Software Vault: The Gold Collection/Software Vault - The Gold Collection (American Databankers) (1993).ISO/cdr11/fdanews.zip/FDA-NEWS

Text File | 1993-06-03 | 101KB | 1,739 lines

read


P93-21                             Food and Drug Administration
FOR IMMEDIATE RELEASE              Mike Kubic [phone]
June 3, 1993                       (Home) -- [phone]

    The Food and Drug Administration today announced a program to improve the
safety of drugs, biologics, medical devices, dietary supplements, medical
foods, infant formulas and other regulated products by encouraging health
professionals to report serious adverse events and product defects.
    The new program -- called MEDWatch -- is a comprehensive approach to
FDA's post-marketing surveillance and is aimed at more involvement by health
professionals and a better focus of their reporting.
    Clinical trials that precede product approval typically include safety
data on several hundred or several thousand patients.  Once on the market, the
much wider use of the drug or medical device occasionally brings out
additional data on the safety and efficacy of the product that can have a
bearing on its use. The purpose of MEDWatch is to bring this information to
FDA's attention as soon as it is gathered by health professionals.
    "MEDWatch is not just a new FDA system; it is a way of making reporting
of adverse events and product problems a part of the culture of health care
providers," said FDA Commissioner David A. Kessler, M.D. "Physicians, nurses
and others who care for patients are the first to know when a drug or
medical device does not
                                     -MORE-


                                       Page 2, P93-21, MEDWatch
perform as it should.  The sooner they report it to FDA, the faster the
agency can analyze the problem and take corrective action."
    The American Medical Association, Pharmaceutical Manufacturers
Association, Public Citizen Health Research Group and more than 50 other
organizations representing health professionals have agreed to promote the
program to their members by special mailings, ads and other means.
    As part of MEDWatch, the agency has developed several ways to make it
easier for health professionals to report adverse events involving almost
all regulated products. Concerns with vaccines will continue to be reported
separately through the Vaccine Adverse Events Reporting System.
     An important part of MEDWatch is a simplified reporting form that
replaces five other forms previously issued for the same products.
    The self-addressed, one-page form, which can be folded and mailed
postage-free, will be made widely available in several publications,
including the Physicians' Desk Reference, the FDA Medical Bulletin and AMA
Drug Evaluations.
    In addition, the agency has established for adverse event information a
special 24-hour, 7-day-a-week toll-free telephone line. Health professionals
will also be able to make their reports electronically by computer.
                                     -MORE-



                                        Page 3, P93-21, MEDWatch
    FDA keeps track of the performance of drugs, biologics and medical
devices on the basis of mandatory reports -- from manufacturers and device
distributors and user facilities -- and voluntary reporting by health care
professionals.
    FDA has repeatedly identified side effects that did not emerge during the
clinical trials of drugs. Adverse drug reaction reports led to the recall of
such drugs as suprofen, which in 1986 was found to cause flank pain
syndrome, and temafloxacin, which last year was linked to hemolytic anemia
in some patients.
    Two years ago, FDA discovered a potentially fatal latex sensitivity that
prompted an alert to health professionals. In 1992, voluntary reports by
health professionals about product quality problems resulted in 52 drug
recalls. In addition, manufacturers voluntarily accepted many FDA
recommendations for corrective actions to improve the quality of their
products.
    However, in a typical year fewer than one-third of all adverse drug
reaction reports and fewer than one-half of medical device problems reported
to FDA involve serious patient outcomes. Moreover, a survey has indicated
that as many as 50 percent of physicians are not aware of FDA's adverse
events reporting system.
    MEDWatch is designed to stimulate voluntary reporting by all health care
professionals, and to focus them on adverse events that represent a serious
health hazard.
                                     -MORE-
                                       Page 4, P93-21, MEDWatch
    To encourage maximum participation in the program, the agency will hold
next year a special conference on medication- and
device-induced problems for academics and practitioners. FDA will also make
a sustained effort to keep health professionals informed about the use of
their MEDWatch reports, and it will encourage medical, pharmacy, dental and
nursing schools to include in their curricula lectures on adverse event and
product problem recognition and reporting.
    Adverse events that should be reported include the patient's death,
life-threatening illness or injury, hospitalization, disability, congenital
anomaly and experiences that required intervention to prevent permanent
impairment of health. MEDWatch also needs to be informed about suspected
contamination, questionable stability, defective components and poor
packaging or labeling of regulated products.
    FDA is one of the eight Public Health Service agencies in HHS.
                                      ####


P93-20                                     Food and Drug Administration
FOR IMMEDIATE RELEASE                      Sharon Snider [phone]
June 2, 1993                               (Home) -- [phone]


     The Food and Drug Administration today announced the approval of a new
medical device to help keep open blocked heart arteries.
     The Gianturco-Roubin Flex-Stent Coronary Stent, made by Cook Inc. of
Bloomington, Ind., was approved for use with balloon angioplasty in patients
whose heart vessels close back up or threaten to close back up during the
procedure.  This occurs in 2 to 11 percent of patients.
     The stent is an implantable, tube-shaped stainless steel mesh device,
about one inch long.  It is designed to remain in the artery after balloon
angioplasty to keep the artery open.
     "The coronary stent gives doctors another tool to treat diseased
coronary arteries," said FDA Commissioner David A. Kessler, M.D.  "It will be
helpful for that small group of patients in whom balloon angioplasty might
otherwise fail, causing heart attacks or even death."
     Balloon angioplasty is used to unclog heart arteries in patients with
atherosclerosis, a progressive disease in which the heart arteries become
blocked with fatty plaque, causing chest pain, heart attack and death.
     In balloon angioplasty, a balloon-tipped catheter is threaded through an
artery in the leg or arm to the heart artery.  When the
                                      -MORE-

                                   Page 2, P93-20, Coronary Stent
balloon reaches the blockage, it is inflated to compress the plaque against
the artery walls.  The balloon is then deflated, and the catheter withdrawn.
 Balloon angioplasty has a high success rate and is less risky and less
costly than bypass surgery.  However, in some instances angioplasty fails and
the artery partially or totally closes back up, forcing emergency surgery or
causing heart attack or death.             The stent helps prevent this problem
by providing a means to keep the artery open.  When it is apparent during
balloon angioplasty that the artery has closed or is threatening to close, the
balloon catheter is withdrawn and a stented balloon catheter is inserted.
When the balloon inflates, the stent's mesh "scaffold" expands and then
remains in place to hold the artery open after the balloon catheter is
removed.
 FDA's decision to approve the heart stent was based on a review of clinical
studies of 306 patients at 13 medical centers for two years.  The studies
showed that the stent significantly reduced the need for bypass surgery and
incidence of heart attack in patients whose artery had closed or threatened to
close back up during balloon angioplasty.
 Another stent--the Palmaz Balloon-Expandable Stent made by
Johnson & Johnson Interventional Systems Co. of Warren, N.J.--was approved by
FDA in 1991 for use on leg arteries.  It was also approved for treating
blockages of major bile ducts when other techniques do not work.
                                      -MORE-

                                  Page 3, P93-20, Coronary Stent
 Physicians perform an estimated 300,000 balloon angioplasties each year.
 FDA is one of eight Public Health Service agencies in the Department of
Health and Human Services.
                                       ####

 


P93-22                            Food and Drug Administration
FOR IMMEDIATE RELEASE             Mike Shaffer [phone]
June 2, 1993                      (Home) -- [phone]


   The Food and Drug Administration has concluded that no over-the-counter
smoking deterrent product on the market today has been shown to be effective
in helping people quit or reduce smoking.  New shipments of these
nonprescription products will be prohibited after Dec. 1.
   Products that will be affected include pills, tablets, lozenges and
chewing gum-type products sold under various names such as Cigarrest,
Bantron, Tabmint, Nikoban and others.  They may continue to be sold until
supplies are exhausted.
   "Smoking is one of the nation's leading public health risks, and we favor
any safe and effective method for helping people kick the habit," said FDA
Commissioner David A. Kessler, M.D.  "However, to reduce smoking-related
illnesses and deaths, smoking deterrents have to work."
     Several manufacturers of the nonprescription products have discussed
with FDA the possibility of conducting clinical trials on lobeline sulfate
and silver acetate -- two ingredients in products now on the market.  Past
studies with these and other ingredients have not proven their effectiveness
in helping people stop or reduce their smoking, FDA reported.
                             -MORE-


                       Page 2, P93-22, OTC Smoking Deterrents

   Several prescription products are approved as smoking cessation aids.
Marion Merrell Dow Inc., which manufactures Nicorette, a prescription
chewing gum drug for this purpose, has expressed interest in gaining FDA
approval for switching the product to nonprescription status, which would
allow its use without the supervision of a physician.  Before allowing a
switch, the agency would need to consider carefully Nicorette's own
potential for addiction, since it contains nicotine.
   FDA, which is a U.S. Public Health Service agency within HHS, believes
that allowing ineffective products to stay on the market discourages
research to find effective ones. The agency has informed companies that it
is anxious to work with them to develop new products in this area.
     The announcement was published as a final rule in the Federal Register
June 1.
                              ####






NOTE TO CORRESPONDENTS                          Mike Kubic
May 26, 1993                                    [phone]
             SPOTLIGHT ON ADVERSE EVENTS REPORTING
     Leaders of the Food and Drug Administration and organizations
representing health professionals, consumers and industry will meet
in Rockville, Md., on June 3 to launch MEDWatch, FDA's initiative
to improve adverse events reporting.
     As part of the program, FDA Commissioner David A. Kessler,
M.D., will hold a joint press conference with representatives from
several organizations that have agreed to promote MEDWatch. The
participants will include among others James Todd, M.D., executive
vice president of the American Medical Association, Gerald
Mossinghoff, president of the Pharmaceutical Manufacturers
Association, and Sidney Wolfe, M.D., director of Public Citizen
Health Research Group.
     MEDWatch is a new FDA system for encouraging and facilitating
reports by health professionals on serious adverse events and
problems with drugs, biologics, medical devices and other regulated
products.
     The day-long conference will start at 9:30 a.m. in the main
ballroom of the Crowne Plaza Holiday Inn, 1750 Rockville Pike in
Rockville, Md., near the Twinbrook Metro. The press conference will
begin at 9:45 a.m. in the Rockville Room of the same hotel.
                              ####P93-17                             Food and Drug Administration
FOR IMMEDIATE RELEASE              Monica Revelle [phone]
May 17, 1993                       (Home ) -- [phone]

     The Food and Drug Administration today announced the approval
of a supplemental application that enables Pfizer Inc. to
manufacture streptomycin sulfate injections to treat patients with
tuberculosis.
     This action should end a shortage that started in mid-1991
after the last U.S. manufacturer ceased production.
     HHS Secretary Donna E. Shalala said, "I am gratified by the
way federal agencies and private industry cooperated to fill an
important public health need.  The end of the streptomycin
shortages shows that even major problems can be overcome by goal-
oriented teamwork.   It's the sort of spirit I'd like to see in
action, again and again."
     FDA Commissioner David A. Kessler, M.D., said, "Tuberculosis
is again on the rise, and Pfizer is to be commended for answering
our call for an assured supply of therapies to curb this
resurgence."
     FDA set out to counter the threat of streptomycin shortages as
soon as they became apparent two years ago.  A special task force
headed by Mary Pendergast, Dr. Kessler's deputy commissioner/senior
adviser, canvassed pharmaceutical manufacturers in the United
States, Europe and Asia to identify a firm to seek approval of this
product for the U.S. market.  In the meantime, the agency took
steps to make possible emergency imports of streptomycin from
Canada.  Last summer, the Centers for Disease Control and
Prevention agreed to distribute the drug supplied for free by
Pfizer under an investigational new drug application by CDC.
     FDA's expedited approval of Pfizer's supplemental application
will enable the firm to resume the manufacture of the injectable
formulation of streptomycin sulfate.
     Reported TB cases in the United States continued to rise in
1992.  After reaching an all-time low of 22,201 cases in l985,
cases reported to CDC climbed to 26,673 -- an increase of 20
percent over the seven-year period and a 1.5 percent increase over
1991.  Evidence from previous years suggests that cases among HIV
infected persons and the foreign born are responsible for much of
the rise.  Increases in recent years in TB cases in U.S. born
children under 5 suggest that since such cases result from recent
infection, increased transmission may also be playing a role.
     CDC guidelines recommend the addition of streptomycin to a
core regimen of isoniazid, rifampin and pryazinamide, to prevent
the emergence of drug resistant TB.  Also, the four-drug regimen
can be more easily administered through directly observed therapy,
since this regimen can be given three times per week from the
beginning of therapy or two times per week after a two-week daily
induction phase.
     FDA and CDC are among the eight Public Health Service agencies
in HHS.
                              ####










P93-18                                Food and Drug Administration
FOR IMMEDIATE RELEASE                 Brad Stone -- [phone]
May 18, 1993                          (Home) -- [phone]

     The Food and Drug Administration today announced results of a
nationwide survey showing that more than 70 percent of food stores
are voluntarily providing nutrition information about raw produce
and seafood.
     "The survey shows that food labeling reform has really caught
on," said FDA Commissioner David A. Kessler, M.D.  "These products
were not labeled in the past.  Now, consumers are demanding more
information about the food they buy, and retailers know it's good
business to give consumers what they want."
     The voluntary participation in the site-of-sale labeling
program satisfies the standard that FDA established under the
Nutrition Labeling and Education Act of 1990 requiring that at
least 60 percent of the stores take part, or the program becomes
mandatory.  Retailers may provide information by a variety of
means, including charts or brochures displayed at the point of
purchase, or through labels affixed to the products.
     The foods covered by the voluntary labeling program are 20
each of the top-selling raw fruits, vegetables and seafood.
                             -MORE-


                                 Page 2, P93-18, Food Survey
     The survey, conducted last November and December in
approximately 2,000 stores from coast to coast, found that 75.7
percent of the sampled stores selling raw fruit and vegetables and
73.2 percent of the stores selling raw seafood were taking part in
the program.
     To comply, retailers must provide consumers with nutrition
information for at least 90 percent of the 60 specified raw
products.  The information displayed must include per-serving
values for calories, protein, fat, carbohydrates, sodium, vitamin
A, vitamin C, calcium and iron.  Information on dietary fiber may
also be provided for fruits and vegetables, and information on
cholesterol and saturated fat for seafood.
     FDA will monitor national produce and seafood consumption data
and update the list of the top 20 varieties of fruits, vegetables
and seafood every two years.  Another survey will be conducted in
1994 to determine whether most food retailers continue to comply
with the voluntary program.  In the meantime, FDA will work with
consumer groups and industry to promote even greater participation.
     The following are the raw products in FDA's program:
VEGETABLES -- Asparagus, bell pepper, broccoli, cabbage, carrot,
cauliflower, celery, corn, cucumber, green bean, green onion,
iceberg lettuce, leaf lettuce, mushroom, onion, potato, radish,
summer squash, sweet potato, tomato.

FRUITS -- Apple, avocado, banana, cantaloupe, cherry, grape,
grapefruit, honeydew, kiwifruit, lemon, lime, nectarine, orange,
peach, pear, pineapple, plum, strawberry, tangerine and watermelon.

SEAFOOD -- Blue crab, catfish, clam, cod, flounder, haddock,
halibut, lobster, mackerel (Atlantic/Pacific and jack), ocean
perch, orange roughy, oyster, pollock, rainbow trout, rockfish,
salmon (Atlantic/coho), scallops, shrimp, sole and whiting.
                             -MORE-

                                 Page 3, P93-18, Food Survey

     FDA is one of the eight Public Health Service agencies in
HHS.
                              ####



P93-19                         Food and Drug Administration
FOR IMMEDIATE RELEASE          Donald McLearn -- [phone]
May 18, 1993                   (Home) -- [phone]

     Carl C. Peck, M.D., director of the Food and Drug
Administration's Center for Drug Evaluation and Research, has
announced that he will retire Nov. 1 after 26 years of federal
service.
     Leiden University in The Netherlands has appointed Dr. Peck as
Boerhaave Professor of Clinical Drug Research for a period of eight
months.  He will be associated with the Division of Pharmacology in
the University's Center for Bio-Pharmaceutical Sciences.  In his
new post, Dr. Peck will teach and conduct research in clinical and
preclinical drug research.
     Dr. Peck has received numerous awards and honors for his work
at FDA, including the U.S. Army's Superior Service Medal, the 1992
UCSF Riegelman Lectureship, the Commissioner's Special Citation and
the Outstanding Service and Distinguished Service Medals of the
Public Health Service.  He has authored more than 100 publications.
     "Dr. Peck brought to FDA the spirit of innovative scientific
management," said FDA Commissioner David A. Kessler, M.D.  "He was
personally committed to strengthening the generic drugs and AIDS
programs."
     Deputy Commissioner for Operations Jane E. Henney, M.D., said,
"Dr. Peck has been tireless in recruiting talented medical
                             -MORE-


                                     Page 2, P93-19, Peck Retiring
scientists for the new drugs review program.  He has left his mark,
and he will be missed."
     Dr. Peck came to FDA in 1987 from the Uniformed Services
University of the Health Sciences in Bethesda, Md., where he had
been professor of medicine and pharmacology and director of the
division of clinical pharmacology since 1980.  He earned his M.D.
degree from the University of Kansas Medical School in 1968.  His
special research interests are in experimental design, data
analysis, pharmacokinetics and transdermal chemical permeation.
                              ####

P93-16                                 Food and Drug Administration
FOR IMMEDIATE RELEASE                  Mike Shaffer [phone]
May l2, 1993                           (Home) -- [phone]

   The Food and Drug Administration today proposed sunscreen labeling
requirements designed to help sunbathers better protect their skin
from sun damage. The proposals would require that:
   -- sun protective factors (SPFs) be limited to a maximum of 30;
   -- cosmetic products for tanning that contain no sunscreen display
a warning that they do not protect against sunburn; and
   -- all sunscreen and suntan products bear statements about the
sun's potential harm and about the product's ability to protect
users.
     One statement that FDA proposes to require on sunscreens reads:
"Sun Alert: The sun causes skin damage.  Regular use of sunscreens
over the years may reduce the chance of skin damage, some types of
skin cancer and other harmful effects due to the
sun."
   "There is overwhelming evidence that overexposure to radiation
from the sun is a health hazard," said FDA Commissioner David A.
Kessler, M.D.  "Consumers should not have to guess how much
protection, if any, they'll
get from the sunscreen and tanning products on the market."
                               -MORE-


                                      Page 2, P93-16, Sunscreens
   If finalized, the new document -- known as a monograph -- would
revise and update sunscreen standards originally proposed in 1978 and
reviewed again at a public meeting in 1988. Since the late 1970s,
considerable advances have been made in understanding the effects of
radiation from the sun on the body, while the number of doctors'
office visits for skin cancer has increased more than 50 percent.
Skin cancers in which ultraviolet radiation from the sun plays an
important role are the most common form of cancer.
   Hundreds of comments have been received over the years from
industry, professional and consumer groups and individuals about
sunscreens. Twenty active ingredients, some already in use, are being
proposed as safe and effective for use in sunscreen products.
   The proposal increases to 30 the highest number of permissible sun
protection factors, a value twice as high as was stated in the
standards proposed in 1978.  SPF numbers above 30, which have since
then appeared on some products, may be used until a final  regulation
becomes effective, but such values are not considered necessary for
most consumers.  SPF is an indication of how long users who apply the
sunscreen properly can expect to safely stay in the sun without
burning. The higher the SPF number, the more protection is provided.
   According to the proposal, labeling will advise that products used
on children between six months and two years of age should provide a
minimum SPF of four, and that parents should consult a
                               -MORE-






                                        Page 3, P93-16, Sunscreens
physician about using sunscreen on children under six months old.
   Any product that refers to an SPF or makes other sunscreen claims
would be considered a drug and subject to the full sunscreen
requirements.  Although FDA considers all products, including
cosmetics such as lipsticks and shampoos that make sunscreen claims,
to be drugs, alternative labeling would be allowed to distinguish
between products intended for everyday use and those intended to
protect against prolonged and intense exposure to the sun.
    Among other issues discussed in the proposal are claims that a
product is waterproof or water resistant and claims for sunless
tanning, tanning pills and tanning accelerators.
   FDA is one of the eight Public Health Service agencies within HHS.
                                    ####
  






          STATEMENT BY THE FOOD AND DRUG ADMINISTRATION




     The Food and Drug Administration today announced it is
prepared to approve -- with restrictive labeling -- the Reality
Female Condom, the first barrier contraceptive for women that also
offers limited protection against sexually transmitted diseases
(STDs).  The label will be required to emphasize that for "highly
effective protection" against STDs, including AIDS, it is important
to use latex condoms for men.
     The female condom consists of a lubricated polyurethane sheath
with a flexible polyurethane ring on each end.  One ring is
inserted into the vagina much like a diaphragm; the other remains
outside partially covering the labia.
     In addition to the required endorsement of the safety offered
by latex condoms for men, the approval for the product will be
granted with these conditions:
     * The label must compare the pregnancy rate for female condom
users -- approximately 26 percent per year -- to rates for other
women's barrier contraceptives, which are lower.
     * The manufacturer must take part in additional effectiveness
studies for the product.
     "The female condom is not all we would wish for, but it is
better than no protection at all," FDA Commissioner David A.
Kessler, M.D., said.  "I have to stress that the male latex condom
remains the best shield against AIDS and other sexually transmitted
diseases. Couples should go on using the male latex condom."
     FDA's decision to approve the female condom was based on a
review of clinical data submitted by the manufacturer and the
unanimous recommendation of the Obstetrics and Gynecology Devices
Advisory Panel at its meeting on Dec. 10, 1992.
     The agency gave the product an expedited review because it saw
an urgent need for a means whereby women can protect themselves
without depending on the cooperation of their partners. FDA had
reservations about the limited data available on protection the
female condom offered against STDs, as well as about the high
pregnancy rate among users, the small number of women in the
clinical studies and the short duration of the studies, which
lasted less than a year. Eventually, the agency decided to approve
the female condom as the only product of its kind ready for
marketing.
     The manufacturer -- Wisconsin Pharmacal of Jackson, Wisc. --
studied 200 women who used the device for six months.  In the
study, the six-month pregnancy rate among U.S. women was
approximately 12.5 percent--or an estimated 26 percent per year.
This high rate is believed to have been the result of improper use
of the device.  It compares to an expected rate of 85 percent among
women not using any contraceptive method.  Women who use the device
correctly each and every time they have intercourse can expect a
much lower pregnancy rate.

     Details of the required studies on the product's effectiveness
are being worked out.
     FDA is one of the eight Public Health Service agencies within
HHS.
                              ####











P93-15                            Food and Drug Administration
FOR IMMEDIATE RELEASE             Susan Cruzan -- [phone]
April 26, 1993                    (Home) - 301-926-7081

     The Food and Drug Administration today recommended that at the
present time doctors stop using a 100 milligram per day dose of the
new heart drug Manoplax (flosequinan).
     This recommendation is based on the results of a controlled
trial comparing Manoplax and a placebo that showed a significantly
increased risk of death in patients taking 100 mg. of the drug.
Increased mortality has not been seen in patients given 75 mg. of
the drug, and both the 75 mg. and 50 mg. doses may still be used.
     Patients on Manoplax should not alter their use of the drug
before consulting with their physicians.
     The study, being conducted by the manufacturer, Boots
Pharmaceuticals, has been evaluating the effects of two doses of
the drug on the survival of patients with severe congestive heart
failure.
     A Dear Doctor letter has been prepared by Boots that will
provide information about this development to medical
practitioners.  This letter is being sent by overnight mail to
selected cardiologists and internists.  A mailgram, detailing the
same information, is being sent to pharmacists, hospital pharmacies
                             -MORE-


                                         Page 2, P93-15, Manoplax
and primary care physicians.  Additional information is also
available from the company.   Manoplax was approved by FDA on Dec.
30, 1992, for the management of congestive heart failure in
patients who do not respond to or cannot tolerate certain other
medications.  It was released for marketing in late March 1993.
FDA is one of eight Public Health Service agencies in HHS.
                               ####

P93-14                               Food and Drug Administration
FOR IMMEDIATE RELEASE                Sharon Snider [phone]
April 26, 1993                       (Home) -- [phone]

      The Food and Drug Administration has told six major hearing aid
manufacturers and distributors to stop making misleading claims about
product performance or face regulatory action.
      The warnings were issued to Dahlberg Inc., Golden Valley, Minn.;
Electone Inc., Longwood, Fla.; Siemens Hearing Instruments, Piscataway,
N.J.; Omni Hearing Systems, Carrollton, Texas; Starkey Laboratories Inc.,
Eden Prairie, Minn.; and Beltone Electronics Corp., Chicago, Ill.
      FDA warned the firms in letters sent on April 16 that their
advertising, promotion and labeling mislead the public by creating
unrealistic expectations for the performance of their products. The firms
represent some of the largest hearing aid manufacturers and distributors in
the United States.
      "FDA will not tolerate misleading claims on hearing aid products,"
said FDA Commissioner David A. Kessler, M.D.  "These companies have
overstepped the line with their advertising.  They must comply with the
law, or the agency will take further action, including seizure of the
product from the marketplace."
      FDA told the companies to remove all misleading promotional
literature and advertising immediately and warned that continued
distribution of the hearing aids with misleading claims could
result in enforcement actions such as seizure, injunction and civil
penalties.  The agency also advised the firms to correct the misconceptions
they have created by their misleading promotion and advertising.
      Under FDA regulations, companies may make claims about hearing aids
as long as those claims can be supported by clinical data.  FDA said that
the companies getting letters have been claiming that their hearing aids
                                  -MORE-

                                       Page 2, P93-14, Hearing Aids
significantly improve speech recognition and intelligibility in noisy
environments such as restaurants, baseball games, crowded rooms, theaters
and church.  The agency said the claims imply that users will be able to
distinguish speech sounds from extraneous noises and that the hearing aids
will not amplify background noises.  These claims are misleading and are
not supported by clinical data.
      According to the agency:
      --The promotional materials fail to disclose important information
about the limits of the devices' effectiveness, and imply that most or all
people who use these hearing aids will benefit equally--a generalization
that is not supported by scientific data.  For example, although the
hearing aids may improve the volume of sound for the user, they may not
improve the intelligibility.  The agency said these firms fail to disclose
that some background noises will be amplified, and that some speech sounds
will not be.
      --The promotional materials overstate the quality and value of-MORE-
the hearing aids with such claims as, "If you have nerve deafness, hearing
again is no big thing."
      --The promotional materials also mislead the public by including
testimonials that are not supported by documentation or scientific
evidence.
      Among the products in question are: Starkey Laboratories' Secret Ear;
Beltone Electronics' ClearVoice, Prima LFE and Opera; Electone's Gold
Series, Faro I and II, Neptune and M30; Dahlberg's Miracle-Ear Clarifier
and Micro Elite; Siemens' LifeSound models; and Omni Hearing Systems'
Enviro 2000.
      The firms were given 15 days to inform the agency of corrective
action they will take to bring their products into compliance with the law.
                                  -MORE-

                                       Page 3, P93-14, Hearing Aids
      An estimated 5.8 million people in the United States use hearing
aids.
      FDA is one of the eight Public Health Service agencies within HHS.
                              ####



P93-9                                       Food and Drug Administration
FOR IMMEDIATE RELEASE                       Monica Revelle - [phone]
March 30, 1993                                (Home) -- [phone]

    The Food and Drug Administration today announced approval of a combination
vaccine against four serious illnesses that affect small children.  When
started in infancy, the new combination vaccine will allow immunization
against the diseases using four injections, instead of the eight injections
which are currently needed.
    The diseases are diphtheria, tetanus, whooping cough (pertussis) and
Haemophilus influenza type b, the leading cause of meningitis.
    "As secretary of HHS, I call this good news.  If I were an infant about to
get four fewer shots, I'd call it great news," said HHS Secretary Donna E.
Shalala.
    The new vaccine is composed of diphtheria and tetanus toxoids and
pertussis vaccine adsorbed (DTP), and Haemophilus b conjugate vaccine.  A
series of four injections of the combination vaccine has been found to be as
effective as the eight injections of the DTP and Haemophilus b conjugate
vaccines that have been used to provide protection against the same diseases
for almost a decade.
    "Any new product that reduces the need for medical procedures without a
loss of effectiveness is a step in the right direction," said FDA Commissioner
David A. Kessler, M.D. "We're satisfied that the combination vaccine is safe
and gives children the protection they need."
                                    -MORE-

                                                Page 2, P93-9, Vaccine
     The new vaccine is recommended for use in children at 2, 4, 6 and 15
months of age.  The clinical trials included 6,793 children who were immunized
with the combination product and 4,232 children who were immunized separately
but simultaneously with the two older vaccines.
    The results showed no significant difference in antibody response between
the two groups. The vaccines were comparable in the frequency and types of
adverse reactions reported, the most common of which were fever, redness and
inflammation at the injection site, and irritability.
    The combination vaccine is manufactured by Lederle Laboratories and Praxis
Biologics, Inc., subsidiaries of American Cyanamid Co. in New York, N.Y.  The
product will be marketed under the name Tetramune.
    Most children have their required vaccines by the time they enter school.
But since many infectious diseases are particularly dangerous in very small
children, public health officials have sought to get children immunized before
age 2.
    To be appropriately immunized by the age of 2 years, a child often will be
given three of the following four shots -- DTP, Haemophilus influenza type b,
hepatitis B and measles-mumps-rubella vaccine -- at the same time, at sessions
at two months, four months, six months and 15 months.  (Polio vaccine is given
orally at three of these times as well.)  Combining Haemophilus influenza type
b in a single vaccine with DTP could reduce the shots to as few as two at each
session -- and also reduce the total number of injections needed during this
period.
                                     ###


NOTE TO CORRESPONDENTS                                Chris W. Lecos
March 5, 1993                                         (202-205-4144)

               FDA EXTENDS BOTTLED WATER COMMENT PERIOD 30 DAYS

    FDA has agreed to extend the comment period on a proposed regulation for
defining the various types of bottled water from March 8 to April 7.  The
proposed labeling definitions for "mineral," "spring," "artesian," "well,"
"distilled" and "purified" bottled waters were first announced in the Federal
Register on Jan. 5.
    FDA had received extension requests from various industry groups and
companies saying they needed additional time to complete surveys of consumer
perceptions of spring and other types of bottled water.
    The 30-day extension does not apply to FDA's other Jan. 5 proposals that
would set new limits for various chemical and other contaminants in bottled
water.
                                     ###P93-8                                       Food and Drug Administration
FOR IMMEDIATE RELEASE                       Sharon Snider--[phone]
March 2, 1993                               (Home) -- [phone]

    The Food and Drug Administration today announced that it has cleared for
marketing the first cholesterol test available for home use by consumers
without a prescription.
    Previously, cholesterol tests, which are used to help determine the risk
of heart disease, were available only for use by medical professionals.
    The test--the Accumeter Cholesterol Self-Test, made by Chem Trak Inc. of
Sunnyvale, Calif.--comes in a kit and allows the user to find the level of
cholesterol in the blood in about 15 minutes.
    "This test can help give consumers greater opportunity to monitor their
health and take steps to prevent disease," said Health and Human Services
Secretary Donna E. Shalala.  "Making it more convenient to check on
cholesterol can help ensure that people are aware of the level so they can see
a doctor before serious problems develop."
    High cholesterol is only one factor that leads to heart disease.  Others
include high blood pressure, smoking, obesity and family history of heart
disease before age 55.  An estimated 17.6 million Americans have heart
disease, which claims some 734,000 lives in the United States annually.
    The agency's decision to allow the test to be sold over-the-counter is
based on results of a multi-center clinical trial involving nearly 500
adults.  The firm's study showed the test to be as accurate as cholesterol
tests used by doctors and medical laboratories.
    "Accuracy is crucial," said David A. Kessler, M.D., Commissioner of Food
and Drugs.  "It is also important, as the study showed, that participants were
able to read and understand the instructions and perform the test without
assistance," he noted.
    To perform the test, the user pricks his finger, squeezes blood into a
cassette that contains a test strip and then waits 10 to 15 minutes for
results.  The strip changes color as the cholesterol rises on it.  When the
time is up, the user compares the height of color shown on the cassette with
an accompanying conversion chart to get the cholesterol reading.
    The test measures total cholesterol.  It does not measure individual
components, such as LDL or HDL cholesterol.  A reading of less than 200 is
desirable; 200 to 239 is borderline high; and 240 or above is high, meaning
the user may be at a greater risk for heart diesase.  People whose cholesterol
is borderline or high should see a doctor.
    The National Institutes of Health's National Cholesterol Education Program
recommends that people with a reading in the desirable range have their
cholesterol checked once every five years, and that those whose cholesterol is
borderline or high follow the recommendation of their doctor for frequency of
testing.
    The home test should not be used by hemophiliacs or by people who take
medicine to thin blood because of the possibility of excessive bleeding from
the finger prick.  Those individuals should have their cholesterol checked by
their doctors.
                                    -MORE-


                                                  Page 2
    The package labeling for the test includes detailed instructions for
proper use and a discussion of the test's limits.  It also includes
information on cholesterol, heart disease, diet and exercise and lists a
toll-free number consumers can call for additional information.  The number is
1-800-927-7776.
    Other home tests approved by FDA include tests for ovulation, pregnancy,
blood glucose, hidden fecal blood, blood pressure and urinary tract infections.
    FDA and NIH are among the eight Public Health Service agencies within the
Department of Health and Human Services.
                                     ###NOTE TO CORRESPONDENTS                               Brad Stone
March 2, 1993                                        [phone]

           FDA TO HOLD PUBLIC MEETING ON MONOSODIUM GLUTAMATE (MSG)
    FDA today announced that it will hold a public meeting on April 7, 1993,
on the food ingredient monosodium glutamate (MSG) and related glutamates.  The
meeting is being organized by the Federation of American Societies for
Experimental Biology (FASEB), under a contract with FDA, to provide a public
forum for submission of scientific data on the safety of MSG.  The meeting
will be at FASEB's Chen Auditorium, 9650 Rockville Pike, Bethesda, Md.
    MSG has been used widely as a food ingredient for many years and has been
generally recognized as safe (GRAS) by FDA.  However, the agency has received
numerous anecdotal reports of adverse health effects associated with the
consumption of MSG or other glutamates, and believes it could be that some
sensitive people may suffer reactions if they consume significant quantities.
Speculation about these possible effects has caused concern about MSG among
segments of the public.
    As part of FDA's ongoing evaluation of the safety of GRAS substances,
including MSG, the agency sponsored two extensive evaluations by FASEB -- in
1978 and 1980 -- to review MSG's safety.  Both studies concluded that MSG was
safe at current use levels.
                                    -MORE-


                                                              Page 2

    In September 1992, the agency asked FASEB to evaluate the current
scientific data related to alleged adverse reactions to MSG.  FASEB published
a preliminary report in February 1993 and determined that some additional data
are required for its final report.  A second part of this study, due to be
completed around March 1994, will evaluate scientific data pertaining to the
biological effects of MSG consumption.  The April 7 meeting is designed to
solicit additional data and information for use by FASEB in preparing its
final report.
    Anyone wishing to make a presentation at the public meeting should submit
a written request to Life Sciences Research Office, Federation of American
Societies for Experimental Biology, 9650 Rockville Pike, Bethesda, MD
20814-3998, and to Dockets Management Branch (HFA-305), Food and Drug
Administration, Room 1-23, 12420 Parklawn Dr., Rockville, MD 20857.  The
request must be received no later than March 19, 1993.  Anyone who is unable
to attend the meeting but would like to submit data for consideration should
provide two written copies of the material to FDA and FASEB (at the above
addresses) on or before April 5, 1993.
                                     ###
NOTE TO CORRESPONDENTS                       Brad Stone
March 2, 1993                                [phone]

         FDA TO HOLD PUBLIC MEETING ON BUTYLATED HYDROXYANISOLE (BHA)

    FDA today announced that it will hold a public meeting on April 15, 1993,
to solicit scientific data and information on the food ingredient butylated
hydroxyanisole (BHA).  The meeting is being organized for FDA by the
Federation of American Societies for Experimental Biology (FASEB) and will be
held at FASEB offices, 9650 Rockville Pike, Bethesda, Md.
    Information presented at the meeting will be used by FASEB to prepare a
report for FDA on the safety of BHA.  Questions about the safety of BHA have
arisen, in part, from some studies that indicated an association between BHA
and cancer in two animal species.  FDA has asked FASEB to reexamine all
available data on the safety of BHA and evaluate whether these animal studies
are relevant to the occurrence of cancer in humans.
    For further information contact:  Sue Ann Anderson or Elwood O. Titus,
Life Sciences Research Office, Federal of American Societies for Experimental
Biology, 9650 Rockville Pike, Bethesda, Md. 20814, [phone]; or Office
of Policy, Planning and Strategic Initiatives, Food and Drug Administration,
200 C St., S.W., Washington, D.C. 20204, [phone].
                                     ###P93-7                                           Food and Drug Administration
FOR IMMEDIATE RELEASE                           Susan Cruzan--301-443-3285
March 2, 1993                                   (Home) -- 301-926-7081

   The Food and Drug Administration today announced approval of a
one-treatment intravenous drug for hairy cell leukemia, a rare, often fatal
cancer of the blood and bone marrow.
   The drug, cladribine, with the trade name of Leustatin, is given to
patients in one continuous treatment over a seven-day period rather than in
several separate treatments over a period of months, as required for other
cancer drugs.  While most cancer drugs act on one specific stage of cell
activity, cladribine destroys both dividing cells and cells at rest.
   The U.S. approval is the first in the world.
   "The drug provides an important new option for patients with hairy cell
leukemia," said FDA Commissioner David A. Kessler, M.D.  "The single treatment
required with this drug represents a significant advance."
   In clinical trials, 89 percent of patients treated once with Leustatin
experienced either complete or partial remission of their cancer for eight to
25 months.  Signs of remission include a return to normal blood and bone
marrow counts without disease symptoms such as fatigue, anemia and recurrent
infections.
   At present, patient followup is too short to assess the long-term benefits
of the drug.  For this reason, the company will be following patients who took
part in the clinical trials and reporting the results to FDA.
   Because only one treatment is required, patients may not experience some of
the recurrent side effects frequently associated with multiple treatments,
such as nausea, vomiting, headaches and rashes.  The most serious side effects
associated with Leustatin include fever and a low white blood cell count
during the first two months after treatment.
   Hairy cell leukemia is named for the "hairy" appearance of the cancer cells
under the microscope.  The disease currently affects about 3,000 patients,
mostly men.  About 600 new cases occur each year.  Due to the low incidence of
the disease, Leustatin has been designated as an "orphan" product.  This
designation provides incentives for companies developing products for rare
diseases -- those affecting fewer than 200,000 people in the United States.
   The drug was granted a treatment IND in early l992, allowing its expanded
use prior to approval.  It will be marketed by Ortho Biotech Inc., of Raritan,
N.J., an affiliate of Johnson and Johnson.
   FDA is one of the eight Public Health Service agencies within HHS.
                                     ###


P93-6                                             Food and Drug Administration
FOR IMMEDIATE RELEASE                             Brad Stone -- [phone]
Feb. 23, 1993                                     (Home) -- [phone]

     The Food and Drug Administration today warned consumers to be careful
when using many aerosol hairspray products to avoid the danger of serious
burns.  These products may catch fire if exposed to an open flame.
     "It's important for consumers to read and heed the warnings that appear
on product containers and to keep them away from children," said FDA
Commissioner David A. Kessler, M.D.  "Hairspray fires are particularly
dangerous to the user because the product is used around the head.  Others
nearby may also be injured."
     Aerosol hairsprays that contain flammable ingredients are labeled with
warning statements on proper use.  While the exact wording and location on the
label may vary, all provide this basic information:  Flammable.  Avoid heat,
fire and smoking during use until sprayed hair is fully dry.
     FDA's warning was prompted by recent reports of injuries and deaths
resulting from aerosol hairspray-related fires.  In many of these cases,
inadvertent exposure of the aerosol hairspray to lit cigarettes, matches or
lighters -- either directly or before the hairspray completely dried on the
hair -- caused ignition and serious burns to a user's hair and upper body.
Recently, a woman in Kansas suffered fatal burns after apparently trying to
light a cigarette before the hairspray had completely dried on her hair.
                                    -MORE-


                                                 Page 2, P93-6, Hairspray
     As with many aerosol cosmetic and household products, the flammability of
most aerosol hairsprays is attributable to the use of hydrocarbon propellants
in combination with SD alcohol 40 solvent.  This mixture has been widely used
to replace chlorofluorocarbons (CFCs), which were banned from aerosol
propellent use in the United States in 1978 because of environmental concerns.
     FDA is exploring ways to enhance the effectiveness of label warnings.
The agency is also looking into new approaches for heightening consumer
awareness of hairspray-related fire hazards to protect the public health.
     FDA is one of the eight Public Health Service agencies within the
Department of Health and Human Services.
                                     ###


P93-5                                    Food and Drug Administration
FOR IMMEDIATE RELEASE                    Betsy Adams - [phone]
Feb. 3, 1993                             (Home) - [phone]


     Commissioner of Food and Drugs David A. Kessler, M.D., today announced
the appointment of Bruce Burlington, M.D., as director of the Food and Drug
Administration's Center for Devices and Radiological Health.
     The center is responsible for ensuring the safety and effectiveness of
all medical devices, including heart valves, breast implants, hip and joint
replacements and hospital equipment.  The center also ensures the safety of
consumer and medical radiation-emitting equipment, such as x-ray machines,
microwave ovens, mammography machines and television sets.
     "Dr. Burlington has demonstrated his ability to resolve complex issues of
health and public policy, and he is a strong and effective manager," Dr.
Kessler said.  "His experience in enhancing product development and review
across the agency -- in biologics, in generic drugs and, most recently, with
new drugs -- will serve him well in the regulation of new medical technologies.
     "These technologies can mean the difference between life and death," Dr.
Kessler added, "and Dr. Burlington's appointment demonstrates FDA's commitment
to fostering the availability of safe and effective medical devices."
     Dr. Burlington joined FDA in 1981.  Since 1988, he has been deputy
director of the Office of Drug Evaluation II in the Center for Drug Evaluation
and Research (CDER), with responsibility for scientific and managerial
supervision of anti-infective, antiviral, metabolic and endocrine drug
                                    -MORE-


                                           Page 2, P93-5, CDRH-Burlington
products.  From 1989 to 1990, he also served as acting director of the Office
of Generic Drugs.  Since 1990, he has held the post of deputy director for
medical affairs of CDER, as a collateral duty.
     "In his medical affairs post, Dr. Burlington has been especially active
in international harmonization of drug approval standards, program
accountability and productivity," said Deputy Commissioner for Operations Jane
E. Henney, M.D.  "He has been particularly effective in dealing with complex
issues related to the planning and implementation of user fees as well as the
effective use of the agency's scientific advisory committees."
     From 1986 to 1988, Dr. Burlington was in charge of the division of
biological investigative new drugs in the Center for Biologics Evaluation and
Research.  And, from 1981 to 1986, he was a research fellow and then chief of
the respiratory virus laboratory in FDA's biologics unit.
     Dr. Burlington earned his medical degree from Louisiana State University
School of Medicine in 1975.  He came to FDA after completing his internship
and residency in medicine and a fellowship in infectious diseases, at the
University of Colorado Medical Center.
     He succeeds James S. Benson, who recently left the government after a
long and distinguished career in federal service.
     The FDA is one of eight Public Health Service agencies in HHS.
                                     ###








NOTE TO CORRESPONDENTS
Jan. 19, 1992


                  UPDATE ON FDA's OFFICE OF PUBLIC AFFAIRS

    Please note the following appointments in the FDA Office of Public
Affairs:

* Donald C. McLearn, deputy associate commissioner, has been named acting
associate commissioner.  Gary E. Fendler, who had served as associate
commissioner, has left the agency.

* Lawrence L. Bachorik, director, speech writing staff, has been named
acting deputy associate commissioner.

    Mr. McLearn and Mr. Bachorik may be reached at [phone].

    Effective immediately, inquiries from broadcast media should go directly
to Sharan Kuperman, who will direct all the agency's electronic media, at
[phone].

    All print media inquiries should continue to be handled by the Press
Relations Staff.  Betsy Adams, director, Press Relations Staff, may be
reached at [phone].

                                    ###
P93-4                                         Food and Drug Administration
FOR IMMEDIATE RELEASE                         Sharon Snider - [phone]
Jan. 12, 1993                                 (Home) -- [phone]

    The Food and Drug Administration today proposed that manufacturers of
testicular implants be required to submit scientific data to show that these
products are safe and effective.
    Testicular implants, which are made of silicone, are intended for
cosmetic purposes.  They are commonly used to correct congenital
abnormalities in infants and toddlers who are born without one or both
testicles.  They are also used in men who have had one or both testicles
removed because of cancer or other diseases or who have lost one or both
testicles due to injury.  An estimated l,000 are implanted yearly.
    "We need to make sure these devices are safe and effective,"  said FDA
Commissioner David A. Kessler, M.D.  "Therefore, we are proposing that
companies submit data, just as we did for breast implants."
    Testicular implants are pouches that are placed in the scrotum.  They
are made of solid or gel silicone and have a silicone covering.  Some types
are coated with polyurethane foam.
    These implants were on the market prior to the Medical Device Amendments
of 1976, which gave FDA regulatory authority over devices.  Like other
pre-amendment devices, testicular implants were allowed, under the law, to
                                   -MORE-

                                       Page 2, P93-4, Testicular Implants
remain on the market with the understanding that FDA would later require
manufacturers to demonstrate their safety and effectiveness.
    Although some information on the risks and benefits of testicular
implants is available, there is not enough scientific evidence to determine
whether the benefits outweigh the risks.
    The agency's safety concerns regarding the implants involve the lack of
adequate information in these areas:
    * The incidence of leakage, hardening of surrounding tissue and
rupture.  The silicone gel in these implants may leak into adjacent tissue,
causing problems similar to those seen with breast implants.
    * The long-term effectiveness of the implants.  Reported problems of
unknown frequency and origin include infection, pain, discomfort, erosion of
the device and its migration to other parts of the scrotum and abdomen.  It
is also not known how often these complications require corrective surgery.
    * The potential for long-term adverse effects, such as cancer,
immune-related connective tissue disorders and reproductive problems.  This
type of information is particularly important because many of the implant
users are young.
    * The immediate and long-term psychological benefits of the implants,
such as patient satisfaction and improved self-image and psychological
outlook.
    If today's proposal is made final, manufacturers planning to continue
marketing testicular implants will be required to submit a Premarket
Approval Application demonstrating the safety and effectiveness of these
products as a condition for keeping them on the market.
                                   -MORE-

                                       Page 3, P93-4, Testicular Implants
    FDA's call for safety and effectiveness data on testicular implants is
part of the agency's ongoing review of pre-1976 devices.  In addition to
requiring safety and effectiveness data on silicone gel breast implants, FDA
recently proposed calling for safety and effectiveness data on saline breast
implants and will soon do the same for inflatable penile implants, heart
bypass blood pumps and cranial electrotherapy stimulators.
    Today's proposal, which is being published in the Jan. 13 Federal
Register, provides for a 60-day comment period.  Comments may be submitted
to Dockets Management Branch, HFA-305, Rm 1-23, 12420 Parklawn Dr.,
Rockville, Md. 20857.
    FDA is one of the eight Public Health Service agencies within the U.S.
Department of Health and Human Services.
                                    ###
P93-3                                        Food and Drug Administration
FOR IMMEDIATE RELEASE                        Susan Cruzan - [phone]
Jan. 8, 1993                                 (Home) -- [phone]

    The Food and Drug Administration has been receiving inquiries expressing
concern about the supply of Parke-Davis & Co.'s Nitrostat, a nitroglycerin
tablet that is dissolved under the tongue for treatment of acute angina.
Warner-Lambert, which owns Parke-Davis, has reported that problems with new
manufacturing processes for the drug may have temporarily disrupted
distribution of the drug in certain strengths to some outlets.
    Although spot shortages have occurred, the company is quickly
resupplying pharmacies, and no public health problems are anticipated.
According to reports the agency has received, production problems with this
product have been resolved, and full distribution has now resumed.
    The company has released an additional 300,000 bottles of Nitrostat in
the 0.3 and 0.4 milligram strengths, which should take care of any backlogs
and provide an adequate supply of the drug throughout the country by Tues.,
Jan. 12.  Warner-Lambert has informed doctors and pharmacists of the status
of the distribution and is sending an additional letter to pharmacists today
with more details.  The company is shipping the product by air freight to
its distributors, and has established a mechanism to ensure availability to
all pharmacies.
    In the meantime, patients should obtain the drug in normal quantities
only, to ensure adequate supplies for all.  Pharmacists should use prudence
in filling large requests.  Substitution of lower-strength tablets may be
made in some cases where higher-strength tablets are unavailable.  Patients
with questions about this matter should consult their physician or
pharmacist.
                                    ###P93-2                                       Food and Drug Administration
FOR IMMEDIATE RELEASE                       Susan Cruzan - [phone]
Jan. 5, 1993                                (Home) -- [phone]

    The Food and Drug Administration today announced a proposal that
manufacturers of saline breast implants be required to submit evidence of
their safety and effectiveness to keep them on the market.
    Saline breast implants designed for augmentation or reconstruction have
been on the market for about 20 years.  Introduced as an alternative to
silicone gel implants, they have been used by about 10 percent of the one
million women estimated to have breast implants.  These implants are made
using silicone rubber shells inflated to the desired size with sterile
saline solution (salt water) before or after implantation surgery.
    "We are proposing that manufacturers collect and present all relevant
data in support of the safety and efficacy of these implants," said FDA
Commissioner David A. Kessler, M.D.  "In the meantime, women should
carefully read the patient information sheets that accompany the implants
and discuss the risks with their doctors before undergoing implant surgery."
    Among the issues to be addressed by manufacturers are infection,
capsular contracture and interference with mammography.  The implants can
also rupture and rapidly deflate, requiring further surgery.  FDA has
                                   -MORE-


                                            Page 2, P93-2, Saline Implants
received numerous reports of rupture, leakage and deflation associated with
saline implants.
    FDA is relying on physicians to provide patients with the manufacturers'
information sheets on the known risks and unanswered questions concerning
breast implants so that women who are considering implant surgery can weigh
their risks and benefits.
    These devices were on the market prior to the Medical Device Amendments
of l976, which gave FDA regulatory authority over devices.  Like other
pre-amendments devices, saline implants were allowed, under the law, to
remain on the market with the understanding that FDA would later require
manufacturers to demonstrate their safety and effectiveness.
    Although the safety and effectiveness of the saline implants have not
been proven, leakage or rupture would release only salt water, which is not
thought to be harmful.  Nevertheless, like silicone gel-filled implants,
saline implants have a silicone rubber envelope and therefore may not be
entirely without risk.  Although scientific evidence is not available to
establish a risk of immune-related diseases or cancer related to the
silicone envelope of saline implants, these dangers cannot be ruled out.
    In l991, FDA published regulations requiring manufacturers to submit
safety and effectiveness data for silicone gel-filled breast implants.
These implants are still under study to answer questions about the effects
of silicone gel in the body due to gel bleed, rupture and migration of the
gel.
    When today's proposal becomes final, manufacturers planning to continue
the marketing of the saline implants will be required to submit Premarket
                                   -MORE-


                                            Page 3, P93-2, Saline Implants
Approval Applications demonstrating the safety and effectiveness of these
devices as a condition of keeping them on the market.
    The proposal which will be published in the Jan. 8, 1993, Federal
Register provides for a 60-day comment period.  Comments may be submitted to
Dockets Management Branch, HFA-305, Rm 1-23, 12420 Parklawn Drive,
Rockville, Md. 20857.
                                    ###

P92-45                                      Food and Drug Administration
FOR IMMEDIATE RELEASE                       Chris Lecos - [phone]
Dec. 31, 1992                               (Home) -- [phone]

    The Food and Drug Administration today proposed standard definitions for
various terms used on the labels of bottled water.  They include the terms
"mineral," "spring," "artesian," "well," "distilled" and "purified," which
are frequently used on the labels but have had no standard meanings.
    The agency also announced one final rule and two proposals to establish
new limits for approximately 50 chemical and other contaminants that may be
present in bottled water.
    "We want to ensure that bottled water is labeled truthfully," said FDA
Commissioner David A. Kessler, M.D.  "If the label says it's mineral water,
it should be mineral water.  If it's from a municipal water source, the water
should be so labeled."
    FDA is responsible for overseeing the safety of bottled water which, like
other foods, must be processed, packaged, shipped and stored in a safe and
sanitary manner and be truthfully and accurately labeled.  The 1974 Safe
Drinking Water Act makes the Environmental Protection Agency responsible for
the safety of drinking water from public water systems.  This function
includes setting maximum limits for chemical, bacteriological, radiological
and physical contaminants that may be present.
    When EPA adds or amends a contaminant standard, FDA also must adopt a
level for it in bottled water or publish in the Federal Register its reasons
                                    -MORE-


                                             Page 2, P92-45, Bottled Water
for not doing so.  In effect, bottled water generally must meet EPA's purity
and safety requirements for public drinking water.  FDA had already
established quality standards for 31 contaminants.
    The new proposal would define mineral water, which was previously exempt,
as bottled water with at least 250 parts per million in total dissolved
solids.  The water would have to come from a source "tapped at one or more
bore holes or springs, originating from a geologically and physically
protected underground water source..."
    Besides including mineral water in the new regulations, the proposal
would also require it and certain types of flavored bottled waters to comply
with the same minimum contaminant or quality standards required of other
bottled waters.  This proposal is in response to a 1988 petition from the
International Bottled Water Association.
    "We agree with industry on the need to extend bottled water contaminant
standards to mineral water," said Dr. Kessler.  "Production and sales have
increased so dramatically that we think many consumers may be using it in
place of tap water for general consumption."
    Among the other terms included in the proposal, spring water is defined
as bottled water obtained from an underground formation from which water
flows naturally to the surface -- or would if it were not collected
underground.  To be identified as spring water on the label, the water would
have to be collected at the spring or through a bore hole next to the point
where it emerges.
    The proposal would continue to exclude products labeled as "carbonated
water," "seltzer water," "soda water" and "tonic water," which are considered
soft drinks.
                                    -MORE-


                                              Page 3, P92-45, Bottled Water
    Besides defining several terms, the proposal addresses various other
labeling concerns.  For example, water bottled from municipal water supplies
would have to be clearly labeled as such.  The requirement would be dropped
if municipal water was used but was processed and treated so that it could be
labeled as "distilled" or "purified" water.
    The proposal also would require accurate labeling of bottled waters
marketed for infants.  Labeling for such water would have to indicate that it
is not sterile.  The label would have to state that it should be used as
directed by a physician or according to infant formula preparation
instructions.
    FDA also announced a final regulation setting maximum limits for seven
synthetic volatile organic chemicals that may be present in bottled water.
The agency announced two regulations that propose to establish maximum levels
for lead and copper in bottled water and that would establish or modify the
permitted levels for 10 inorganic chemicals and 28 synthetic organic
chemicals, including 10 synthetic volatile organic chemicals, 17 pesticides
and polychlorinated biphenyls (PCBs).  The latter regulation also would
affirm existing contaminant limits for mercury and nitrate.
    These regulations will be published in the Federal Register on Jan. 5,
1993.  The final regulation becomes effective in six months.  The public has
60 days in which to submit written comments on the proposals.  Comments
should be sent to:  Dockets Management Branch, Food and Drug Administration,
12420 Parklawn Dr., Rockville, Md. 20857.  Comments on the definitions
regulation should be directed to Room 1-25, the others to Room 1-23.
    The FDA is an agency of the Public Health Service within HHS.
                                     ###
     The FDA Office of Information Resources Management has created
"FDA on disc" a CD-ROM which contains manuals and documents that can
be used by Scientists, Inspectors and Administrators.

Documents currently available in "FDA on disc":

o CDER CGMP and NDA Guidelines
o Center for VET. Med. Policy and Procedures
o Generic Drug Chemistry Review
o Code of Federal Regulations (Title 21)
o Compliance Policy Guides
o Drug Study/Health Fraud Bulletins
o FDA Import Alert Retrieval System
o FDA Phone Book
o Food Drug Cosmetic Act and Related Laws
o Investigations Operations Manual
o Market Names of Fish
o Medical Products Quality Manual Chapter 15
o New Regulations (Title 21)
o Preamble Medical Devices Reporting Regs.
o Regulatory Procedures Manual Chapter 5
o Regulatory Procedures Manual Chapter 8
o Talk Papers/Press Releases


How do I obtain "FDA on disc"?

    A one year subscription to the quarterly "FDA on disc" is $300.
Please write to the following address to obtain a subscription form:

Food and Drug Administration
Parklawn Computer Center Room 2A-45
Attention: FDA on disc
5600 Fishers Lane
Rockville, Maryland 20857














P92-42                                      Food and Drug Administration
FOR IMMEDIATE RELEASE                       Susan Cruzan - [phone]
Dec. 29, 1992                               (Home) -- [phone]

    The Food and Drug Administration today announced the approval of
sumatriptan, an injectable drug for relief of the acute pain of migraine
headaches.  Migraine is a common condition affecting 16 to 18 million people
in this country.
    "Sumatriptan should improve the quality of life for many of the millions
of people who suffer from these debilitating headaches," said FDA
Commissioner David A. Kessler, M.D.
    Although effective in alleviating pain in a high proportion of patients,
sumatriptan is not a cure for migraines.  Moreover, people with underlying
heart disease should not take the drug because of its potential to cause
constriction of coronary arteries.
    "FDA advises, as a precautionary measure in people who might have
underlying coronary artery disease, that physicians consider giving the
first injection in their office.  This will allow patients to be observed
and treated for adverse reactions, if necessary," said Dr. Carl Peck,
director of the Center for Drug Evaluation and Research.
    While sumatriptan is a prescription drug, it will be available as an
auto-injector, a device designed to self-administer 6 mg., the maximum
recommended dose of the drug to be used by the patient.  Dr. Peck said that
having the first injection given by a doctor would also ensure proper use of
the auto-injector.  Lower doses in patients who do not tolerate 6 mg. can be
                                   -MORE-

                                               Page 2, P92-42, Sumatriptan
given using a separate syringe and single dose vial.  Educational
information, including a videotape, on how to use the automatic injection
device and the injectable vials will be provided to physicians and their
patients.
    The manufacturer will also provide a patient brochure that will explain
the benefits and risks of the drug.  It indicates that while the drug is
effective for many people, it does not work for every headache.  Some of the
side effects patients may experience include a mild, short-lived rise in
blood pressure, fatigue and drowsiness.
    In addition, the patient labeling will advise women of childbearing age
to consider carefully the benefits and risks of using the drug.  In animal
studies of sumatriptan, fetal deaths were seen in rabbits, although not in
rats.
    As part of extensive post-marketing studies, the manufacturer will
collect data on women who become pregnant while on the drug.  Because there
are no adequate and well controlled studies in pregnant women, the labeling
for physicians and patients will also indicate that the drug should be used
during pregnancy only if the benefit justifies the risk.
    In two U.S. clinical trials involving more than a thousand patients with
acute migraine headaches, relief began for a few patients in 10 to 30
minutes following a 6 mg. injection of sumatriptan; 75 percent of patients
reported relief of symptoms within one hour and 80 percent within two hours
after the injection.  Doses as low as 1 mg. have been shown to be effective
for some patients.
    Made by Glaxo, Inc., of Research Triangle Park, N.C., sumatriptan will
be sold as Imitrex injection.
                                    ###










P92-43                                      Food and Drug Administration
FOR IMMEDIATE RELEASE                       Susan Cruzan - [phone]
Dec. 29, 1992                               (Home) 301-926-7081

    The Food and Drug Administration today announced the approval of Taxol
for ovarian cancer that has failed to respond to other chemotherapy, or has
progressed afterward.
    HHS Secretary Louis W. Sullivan, M.D., said, "This is an important,
second-stage use because, although most patients respond to chemotherapy
initially, the disease often recurs.  Ovarian cancer is diagnosed in 21,000
women and claims 13,000 lives each year.  I'm pleased to see the Bush
Administration's recent reforms pay off in expediting this key drug review,
which was among the most complex FDA has faced."
    Dr. James Mason, HHS assistant secretary for health and head of the
Public Health Service, said, "Taxol's quick approval by FDA in a record five
months -- with the cooperation of the National Cancer Institute's network of
investigators -- makes a good conclusion to a year of increased emphasis on
women's health at the National Institutes of Health, FDA and throughout the
Public Health Service agencies."
    "We are committed to expediting the review of drugs for serious and
life-threatening diseases like cancer and AIDS," FDA Commissioner David A.
Kessler, M.D., said.  "Although it is not a cure, Taxol clearly will make a
difference in the lives of many women with ovarian cancer."
                                    -MORE-

                                            Page 2, P92-43, Taxol
    Although Taxol is derived from the bark of the Pacific yew tree,
adequate supplies of the drug are expected to be available, FDA said.
Researchers are also working on alternative sources of the drug.
    Michael A. Friedman, M.D., associate director of NCI's therapy
evaluation program, said, "The Department of Agriculture's Forest Service,
Interior's Bureau of Land Management and Bristol-Myers Squibb Co. have done
outstanding work in procuring adequate supplies of Taxol."
    Also known as paclitaxel, the drug was tested in clinical trials
involving 200 women in the United States.  The drug was further tested in
more than 2,000 patients in treatment referral center studies.  It was found
effective in reducing tumor size by at least one half in 20 to 30 percent of
patients, with an average survival rate of nine months.
    These data were reviewed jointly by officials from FDA and the Health
Protection Branch of the Canadian Department of Health and Welfare.
Bristol-Myers Squibb of Wallingford, Conn., will market the drug.
    Taxol may be particularly useful for patients with ovarian cancer that
has progressed despite treatment with standard chemotherapy regimens and is
resistant to treatment with platinum-based drugs such as cis-platin.
Platinum-based drug regimens have been the most effective standard agents
available for treating ovarian cancer.
    While Taxol is toxic, its risks are outweighed by potential benefits for
patients with advanced ovarian cancer.  Taxol's side effects are similar to
those of other cancer therapies, including hair loss, decrease in white
blood cells -- which may increase susceptibility to infections -- and
numbness of the fingers and toes.
                                   -MORE-

                                                  Page 3, P92-43, Taxol
    Although FDA's approval of Taxol is limited to its use in refractory
ovarian cancer, patients with many other forms of cancer are receiving the
drug in clinical trials.
    FDA and NIH, including NCI, are agencies of the U.S. Public Health
Service within HHS.  A Public Health Service Action Plan for Women's Health
was set in motion last year to emphasize work on such conditions as breast
cancer, reproductive disorders and diseases, substance abuse in women and
osteoporosis.
                                    ###











P92-44                                  Food and Drug Administration
FOR IMMEDIATE RELEASE                   Chris Lecos - [phone]
Dec. 29, 1992                           (Home) -- [phone]

    The Food and Drug Administration today informed consumers that F. B.
Washburn Candy Corp., Brockton, Mass., has agreed to recall its Waleeco
Dainty Filled Candies because they contain peanut butter that is not
declared on the product's label.  People who are allergic to peanuts run the
risk of serious or life-threatening reactions if they consume the candies.
    On Dec. 24, FDA warned people who are allergic to peanuts not to consume
the candies.  Canadian health authorities have issued a similar warning.
    The product has no lot or code number.  It is sold in two-pound,
cardboard cylinders bearing the name, "Waleeco Dainty Filled Candies."  FDA
has not received any reports of illnesses due to consumption of the candies.
    An estimated 53,000 two-pound cylinders of the candies may have been
distributed in this country, primarily in New England and elsewhere on the
eastern seaboard.
    The company has notified its distributors in New England, Maryland, New
York and eastern Pennsylvania of the recall.  The distributors are
contacting local retailers to withdraw the product from their shelves.
    FDA is one of the eight Public Health Service Agencies in HHS.
                                    ###










note to correspondents                             brad stone or chris lecos
december 28, 1992                                  [phone]

                fda publishes nutrition labeling regulations
    final regulations implementing the nutrition labeling and education act
are on display at the federal register today.  they will be published in the
federal register on jan. 6, 1993.  a backgrounder summarizing the most
significant points is attached.
    the regulations, announced dec. 2, 1992, establish new rules for
labeling of virtually all foods (see press release p-92-35, dec. 2, 1992).
although they are final rules, public comments will be accepted, only on
technical matters that have not previously been raised.  comments may be
sent to fda dockets management branch, 12420 parklawn drive - room 1-23,
5600 fishers lane, rockville, md. 20857.  to be considered, they should be
received by the agency no later than the beginning of february.
    copies of the regulations will be available from the government printing
office bookstore, 710 north capitol st., n.w., washington, d.c., telephone
[phone], after they are published in the federal register.  until
then, they may be obtained through the national technical information
service, 5285 port royal rd., springfield, va. 22161, telephone (703)
487-4650; the order number is pb93-134179.
                                    ###













P92-41                                        Food and Drug Administration
FOR IMMEDIATE RELEASE                         Monica Revelle - [phone]
Dec. 23, 1992                                 (Home) 410-290-6575

    The Food and Drug Administration today announced the approval of
rifabutin, a drug to prevent Mycobacterium avium complex (MAC) disease in
people with advanced HIV infection.
    Rifabutin is the first drug approved for the prevention of MAC disease.
Individuals with MAC infection experience chronic debilitating symptoms
including fever, night sweats, weight loss, fatigue, abdominal pain, severe
anemia and liver dysfunction.  Estimates of its prevalence in patients with
advanced HIV infection range from 30 to 50 percent.  In people with AIDS,
this infection can contribute to death.
    "As the first product approved for the prevention of MAC disease, this
drug will provide significant benefits for AIDS patients," said FDA
Commissioner David A. Kessler, M.D.  "It is a welcome addition to the
growing number of products used to fight AIDS and diseases that can
accompany it."
    Patients enrolled in clinical trials who received rifabutin were
one-third to one-half as likely to develop MAC as were patients who received
a placebo.
    The most common adverse reactions associated with rifabutin are rash,
gastrointestinal symptoms, muscle and joint aches and discolored urine.  In
the trials, a decrease in certain infection-fighting white blood cells was
the only serious adverse reaction that occurred in more patients who
received rifabutin than patients who received a placebo.
                                   -MORE-


                                                    Page 2, P92-41, Rifabutin
    Rifabutin was made available in February under a Treatment
Investigational New Drug (IND) protocol, under which FDA allows drug
developers to provide pre-approval access to experimental drugs that are
intended to treat serious and life-threatening conditions for which there
are no satisfactory treatments.  Drugs that are granted Treatment IND status
must have demonstrated through clinical testing that they may be efficacious.
    This is the first drug whose approval was based on research from
multi-center clinical trials conducted in community-based research groups,
according to David W. Feigal, Jr., M.D., director of the Division of
Anti-Viral Drug Products, which is responsible for reviewing rifabutin.
"The approval of rifabutin marks an important medical advancement for AIDS
patients," said Dr. Feigal.
    In September, FDA's Antiviral Drug Products Advisory Committee
recommended approval of rifabutin.  The committee reviewed data from two
clinical trials involving 1,146 AIDS patients whose white blood cells or CD4
helper cell counts were 200 or less.  CD4 helper cells are white blood cells
important in the immune system that are destroyed by the AIDS virus.
    Rifabutin is manufactured by Adria Laboratories, Columbus, Ohio, and
will be sold under the brand name Mycobutin.
                                    ###


P92-40                                          Food and Drug Administration
FOR IMMEDIATE RELEASE                           Monica Revelle [phone]
Dec. 18, 1992                                   (Home) [phone]

    The Food and Drug Administration today announced the licensing of a
vaccine against Japanese encephalitis.  The Japanese encephalitis virus,
which is mosquito-borne, is common in parts of Japan, other Pacific Islands
and the Far East, and it can cause a fatal inflamation of the brain.
    Infection with the virus leads to overt disease in only one of 200
instances.  Illness, however, is usually severe, resulting in death in 25
percent of cases and residual brain disorders in an additional 50 percent of
cases.
    The new vaccine is recommended for certain travelers to Asia -- persons
spending a month or more in areas where the virus is prevalent, or those on
a trip involving extensive outdoor activities in rural areas.  The labeling
will advise travelers also to take personal precautions to reduce exposure
to mosquito bites.
    "This new vaccine represents a major improvement," said FDA Commissioner
David A. Kessler, M.D.  "It is safer and more effective than previously
available products."
    To determine efficacy, the U.S. Army conducted a controlled trial,
involving 65,224 Thai children, that demonstrated a 91 percent efficacy rate
for the vaccine.
    In 1990, the U.S. Army conducted a safety and immunogenicity clinical
trial of the vaccine at two different dosing schedules.  At two months, all
                                   -MORE-

                                                 Page 2, P92-40, Encephalitis
of those vaccinated had developed antibodies.  One year later, all of the
252 patients vaccinated who volunteered to be sampled still had the
protective antibodies.
    In June 1992, FDA's Vaccines and Related Biological Products Advisory
Committee, a panel of outside experts, recommended approval of the new
vaccine.  The panel had previously received data concerning allergic
reactions that had been reported in non-U.S. populations.
    This recommendation was based on additional clinical data from a study
conducted by the U.S. Navy regarding allergic adverse reactions following
immunization with the vaccine.  In this study, the U.S. Navy immunized
35,253 active duty military personnel and their dependents following an
outbreak of Japanese encephalitis on Okinawa.  The overall adverse reaction
rate was 62 per 10,000 persons vaccinated, and reactions were generally mild
to moderate, including hives, itching and wheezing.  Nine persons were
hospitalized (3 per 10,000 persons vaccinated), primarily to allow for
administration of intravenous steroids for hives.  None of these reactions
were considered life-threatening.
    Approximately 20 percent of those who received the Japanese encephalitis
virus vaccine experienced mild to moderate local side effects including
tenderness, redness and swelling.  Ten percent reported fever, headache,
malaise, rash, chills, dizziness, muscle pain, nausea, vomiting or abdominal
pain.
    Persons with certain allergic histories appear to be more likely to
experience an adverse reaction following vaccination.
    The Japanese encephalitis virus vaccine is manufactured by the Research
Foundation for Microbial Disease of Osaka University, Japan (BIKEN).
Connaught Laboratories, Inc., Swiftwater, Penn., is the U.S. distributor.
    FDA is a Public Health Service agency within HHS.
                                    ###









P92-39                                          Food and Drug Administration
FOR IMMEDIATE RELEASE                           Monica Revelle [phone]
Dec. 10, 1992                                   (Home) [phone]

    The Food and Drug Administration today announced the licensing of the
first recombinant DNA-derived clotting factor for use in persons with
hemophilia A.  The product, antihemophilic factor (recombinant), is intended
for the prevention and control of excessive bleeding and for people with
hemophilia A who require surgery.
    Hemophilia A is an inherited disorder, sometimes called classic
hemophilia, in which the blood clotting protein factor VIII is deficient or
missing.  Affected persons are unable to form blood clots adequately and,
therefore, risk serious and life-threatening bleeding.  Replacement therapy
with factor VIII concentrate corrects the defect temporarily but must be
given by intravenous infusion, in many cases daily or more often.
    Prior to the licensure of antihemophilic factor (recombinant), factor
VIII concentrates made from human plasma have been relied upon.  To obtain
sufficient quantities of factor VIII, plasma pools of thousands of donations
were used.
    In the past, some factor VIII made from such pools transmitted hepatitis
and AIDS viruses to patients, but all anti-hemophilic factors currently
licensed in the United States are now manufactured in ways that are believed
to eliminate the risk of transmission of these viruses.
    "The production of factor VIII by recombinant DNA technology eliminates
even the theoretical possibility of the transmission of viruses from
plasma," said FDA Commissioner David A. Kessler, M.D.  "Its approval is a
milestone in the history of treatment of hemophilia."
                                   -MORE-

                                                  Page 2, P92-39, Factor VIII
    Antihemophilic factor (recombinant) is produced by Chinese hamster ovary
cells that have been modified by recombinant DNA techniques to introduce and
express the gene for human factor VIII.  The antihemophilic factor
(recombinant) is highly purified by several steps involving biotechnology
processes.
    Studies of antihemophilic factor (recombinant) were performed both in
persons who had been exposed previously to clotting factor concentrates or
other blood products and those who had not.  The trials demonstrated
pharmacokinetic equivalence to plasma-derived factor VIII and showed that
antihemophilic factor (recombinant) is safe and effective when used
prophylactically or therapeutically in persons with hemophilia A.
    In December 1991, FDA's Blood Products Advisory Committee recommended
approval of antihemophilic factor (recombinant).  However, the committee
requested that additional clinical trials be conducted in previously
untreated patients because antibodies that inhibited the activity of factor
VIII were observed in some persons.  At this time, it does not appear that
the antibodies are more of a problem with antihemophilic factor
(recombinant) than with plasma-derived factor VIII, but more data are
needed.  Such data are being collected from persons who have not previously
received factor VIII.
    Antihemophilic factor (recombinant) is manufactured under a shared
manufacturing agreement between Genetics Institute, Inc., Cambridge, Mass.,
and Baxter Healthcare Corporation, Glendale, Calif.  Genetics Institute will
make the bulk product, and Baxter Healthcare Corporation will manufacture
the final dosage form.  It will be sold under the brand name Recombinate.
                                   -MORE-


                                            Page 3. P92-39, Factor VIII
Antihemophilic factor (recombinant) was approved on the same day in both the
United States and Canada, through collaborative efforts of FDA, the Canadian
Bureau of Biologics and Baxter.
    FDA is a Public Health Service agency within HHS.
                                    ###


P92-37                                      Food and Drug Administration
FOR IMMEDIATE RELEASE                       Monica Revelle - [phone]
Dec. 8, 1992                                (Home) -- [phone]

    The Food and Drug Administration today announced that it will soon
publish new rules to speed the approval of drugs for patients with serious
or life-threatening illnesses, such as AIDS, cancer and Alzheimer's disease.
    "These final rules will help patients who are suffering the most serious
illnesses to get access to new drugs months or even years earlier than would
otherwise be possible," said HHS Secreatry Louis W. Sullivan, M.D.  "The
effort to accelerate FDA review for these drugs has been a long-term
commitment and indeed a hallmark of this administration."
    These rules establish procedures for the Food and Drug Administration to
approve a drug based on "surrogate endpoints" or markers.  They apply when
the drug provides a meaningful benefit over currently available therapies.
Such endpoints could include laboratory tests or physical signs that do not
in themselves constitute a clinical effect but that are judged by qualified
scientists to be likely to correspond to real benefits to the patient.
    Use of surrogate endpoints for measurement of drug efficacy permits
approval earlier than if traditional endpoints -- such as relief of disease
symptoms or prevention of disability and death from the disease -- are used.
    The new rules provide for therapies to be approved as soon as safety and
effectiveness, based on surrogate endpoints, can be reasonably established.
The drug's sponsor will be required to agree to continue or conduct
                                   -MORE-

                                                  Page 2, P92-37, Accelerated
postmarketing human studies to confirm that the drug's effect on the
surrogate endpoint is an indicator of its clinical effectiveness.
    One new drug -- zalcitabine (also called ddC) -- was approved June 19,
using a model of this process, for treating the human immunodeficiency
virus, HIV, the cause of AIDS.
    Accelerated approval can also be used, if necessary, when FDA determines
that a drug, judged to be effective for the treatment of a disease, can be
used safely only under a restricted distribution plan.
    "The new rules will help streamline the drug development and review
process without sacrificing good science and rigorous FDA oversight," said
FDA Commissioner David A. Kessler, M.D.   "While drug approval will be
accomplished faster, these drugs and biological products must still meet
safety and effectiveness standards required by law."
    The new procedures also allow for a streamlined withdrawal process if
the postmarketing studies do not verify the drug's clinical benefit, if
there is new evidence that the drug product is not shown to be safe and
effective, or if other specified circumstances arise that necessitate
expeditious withdrawal of the drug or biologic.
    FDA is a Public Health Service agency within HHS.
                                    ###
Error: /usr/bbs/topics/NEWS/NEW00310 24
YOUR CURRENT TOPIC: NEWS
TYPE QUIT TO LOGOFF OR TYPE HELP FOR AVAILABLE BBS COMMANDS

PLEASE ENTER A BBS COMMAND ==>