TIME: Almanac 1993/TIME Almanac 1993.iso/time/122589/12258900.009

Text File | 1992-09-23 | 6.4 KB | 124 lines

                                                                                BUSINESS, Page 68

What's the Cure for Burnout?


Budget cuts leave the FDA sickly and corporations concerned

By Dick Thompson


    Deodorant soap, pacemakers, food-color additives, blood
banks, coffee, tongue depressors, eyeglass screws, tampons and
cancer drugs -- all come under the scrutiny of the Food and
Drug Administration. The FDA certifies the purity and safety of
one-quarter of all U.S. consumer products, in addition to
regulating the $400 billion food, pharmaceutical and
medical-devices industries. But throughout the 1980s the FDA
has been traumatized by budget and staff reductions, fusses
over testing of drugs to combat AIDS, second-guessing over
poisoned Chilean grapes, corrupt employees and controversies
over the nutritional claims adorning food packages.

    As a result, the agency has a bad case of bureaucratic
burnout. Approval of new drugs requires mountains of corporate
filings, and delays in processing applications now run well over
two years. That has led to more scandal: this summer
investigators discovered that a few generic-drug developers had
bribed underpaid FDA employees to speed up the agency's
responses to the paperwork for their products. Three FDA
reviewers have already pleaded guilty, and more prosecutions are
expected. "This past year has been one of the most difficult in
FDA's history," said Commissioner Frank Young last week.

    Congress, industry and consumer groups agree that something
needs to be done to resuscitate the ailing agency. Young is a
victim of the urge for change: last month Health and Human
Services Secretary Louis Sullivan said he was transferring Young
to a new post -- Deputy Assistant Secretary of Health for Health
Science and Environment -- effective this week. The position was
created especially for Young, and is widely regarded as a
demotion.

    Last week Sullivan went further by announcing the creation
of a blue-ribbon commission to get the FDA back on course. "The
President and I are committed to strengthening the FDA,"
Sullivan declared. In the Senate, meantime, Massachusetts
liberal Edward Kennedy has joined with Utah conservative Orrin
Hatch in a bipartisan effort to beef up the FDA's anemic annual
budget by setting a floor level of $500 million, vs. the current
total of $492 million. Their proposal would also provide the FDA
with a single facility -- currently, it is spread across 22
buildings in Washington, from converted chicken coops to
renovated Army barracks. Even regulated industries, fearing a
loss of consumer confidence, are demanding a stronger FDA. The
agency, as former FDA official Peter Barton Hutt puts it, "is
a precious national resource, and we shouldn't squander it."

    With its meager funds, the FDA is responsible for
monitoring 63,000 food firms, 14,000 drug companies, 13,000
medical-device manufacturers and 1,700 cosmetics houses. During
the Reagan Administration, cutbacks at the FDA were seen by many
probusiness advocates as one important means of unshackling
industry. But now, with the number of staffers at the agency
down to 7,500 from a 1980 high of 8,100, even business lobbyists
are not so sure. "The problems at the FDA stem directly from the
deregulatory process," says John Cady, president of the National
Food Processors Association. "They just do not have the
resources to do the job correctly."

    The shortfall is worsening. Among other things, Congress
reacted to the Reagan cutbacks by passing 23 public health
bills during the '80s, many of them efforts to shore up the
FDA's powers. The action significantly expanded the FDA's
workload. Yet Congress never moved to restore a single lost
staff position or add employees to meet the increased
responsibilities. The advent of an entirely new industry,
biotechnology, demanded an FDA response to more than 950
genetically engineered products during the 1980s.

    Popular pressures have also played a role. As AIDS has
spread, protesters have charged that the agency has been keeping
lifesaving drugs out of the hands of victims. In fact, the FDA
spent $5 million more than the $46 million Congress provided to
seek a cure for the disease. With health-conscious Americans
including less red meat in their diets, the FDA's thin line of
inspectors has been forced to monitor increasing amounts of
seafood, imported fruits and vegetables, and chicken and eggs.
A number of spectacular food-tampering cases, like last March's
poisoned Chilean grape case (only two tainted grapes were
discovered), forced the agency to reassign up to one-third of
all FDA inspectors for long periods of time. "When an emergency
comes along," says one FDA official, "we stop doing things we
were scheduled to do and divert people elsewhere."

    Decaying labs and desperately low salaries have made hiring
another FDA travail. Some important drug-review posts have an
annual turnover rate of 20%. At least one former FDA official
believes many new employees use their stint at the agency to
bolster resumes that are then quickly circulated to industry.

    Amid all the institutional turmoil, Secretary Sullivan's
decision to push out Commissioner Young has been especially
inept. Sullivan has no replacement waiting, and in fact has been
unable to fill many important health jobs because White House
conservatives filter out nominees with proabortion views.
Pro-lifers are sure to scrutinize Young's successor closely
since the agency is likely to decide on approving new
abortion-inducing drugs like RU 486, the pill manufactured by
a French subsidiary of Hoechst.

    With so many intractable problems facing the FDA,
Sullivan's blue-ribbon panel is unlikely to be enough to stop
the agency's decay. Says Democratic Congressman John Dingell,
chairman of the House Energy and Commerce Committee: "It was an
attempt to look like they were doing something, but they aren't
and they won't." In an effort to find some creative financing
for the FDA, the White House has disclosed that it is
considering charging user fees to companies that seek FDA
approval for products. The size of the proposed service charges
has ranged from an official White House suggestion of $1,500 to
Young's own desire for as much as $150,000 for each product.
Those funds would be welcome, but they would represent a tiny
fraction of the cost of refinancing confidence and competence
at the agency.