Americans Receive New Medicines as Quickly as Others, FDA Asserts

Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.

Americans Receive New Medicines as Quickly as Others, FDA Asserts

Washington Post (12/13/95) P. A3
Schwartz, John

Food and Drug Administration Commissioner David A. Kessler said Tuesday that Americans receive new medicines as quickly as citizens of other countries, including treatments ranging from AIDS therapies to drugs for ovarian cancer, multiple sclerosis, cystic fibrosis and osteoporosis. Kessler said the average total development time for a U.S. drug is 11.5 years and cited an FDA study showing that 96 percent of all applications for new drugs and "biologics" are acted upon within the 12-15 month period required by law. Another FDA study revealed that, in cases where approval for a single drug was sought in the United States and another country, the FDA was more likely to have approved the drug first. Gerald J. Mossinghoff, president of the Pharmaceutical Research and Manufacturers of America, said the average total drug development time is really 15 years and fundamental FDA reforms are still a necessity. Related Story: New York Times (12/13) P. C13; Washington Times (12/13) P. B9

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