$Unique_ID{BRK01730} $Pretitle{} $Title{Orphan Drugs} $Subject{Resources Resource Orphans Orphan Drugs Drug pharmaceutical development Manufacturers medicines pharmaceuticals Manufacturing medicine medication medications} $Volume{Z-0} $Log{} Copyright (c) 1991-92,1993 Tribune Media Services, Inc. A Resource About Orphan Drugs ------------------------------------------------------------------------------ The story of the development of Orphan Drugs is one of unusual foresight and astonishing success. An orphan drug is a status granted to a medicine which has been created to treat a rare disease that may affect less than 200,000 people. Because the cost of research to discover such drugs is so high, the Food and Drug Administration (FDA), under the Orphan Drug Act of 1983, may grant the pharmaceutical research company seven years of exclusive marketing, to help the company recover the funds that were spent on development. Such a designation has been granted by the FDA to a total of 442 drugs as of February, 1991. Now the Pharmaceutical Manufacturers Association (PMA), with the assistance of the FDA has published a full sized, 24 page booklet that tells the tale of 176 medicines now in testing for rare diseases. Developing these drugs are 104 companies and 16 other sponsors. In addition all of the orphan drugs approved since the 1983 Drug Act are also listed. There are 54 drugs in development for cancers of all types, 46 drugs for childhood diseases, 31 drugs in development for genetic as well as 24 drugs for AIDS and AIDS related conditions. The listings are very complete, including the names of the medicines, the company or sponsors, development status for drugs still in research, and indications for the already approved drugs. A very complete glossary with definitions of all those medical terms that no one can pronounce, makes this booklet a must. Send your request to Editor, Orphan Drugs in Development, Pharmaceutical Manufacturers Association, Dept. AB, 1100 Fifteenth Street NW, Washington, DC 20005. No need for a stamped envelope, as this book is just to big to fit. My thanks to the PMA for allowing me to offer this booklet to my readers. ---------------- The material contained here is "FOR INFORMATION ONLY" and should not replace the counsel and advice of your personal physician. Promptly consulting your doctor is the best path to a quick and successful resolution of any medical problem.