FDA’s Record on Drug Reviews

James Driscoll’s column on the Food and Drug Administration (Commentary, June 4) suffers from factual inaccuracies and an apparent lack of knowledge of FDA’s real record on drug reviews and approvals.

First, Driscoll quite amazingly downplays the thalidomide tragedy, writing that it resulted in “several hundred birth defects . . . worldwide.” In fact, it is estimated that between 7,000 and 10,000 infants worldwide were born with severe birth defects because of this drug. Later in his column, Driscoll claims that the time taken by the FDA in the review and approval of Interleukin 2 for kidney cancer cost 3,500 lives “exceed(ing) the number of babies deformed by thalidomide.”

Never mind Driscoll’s math, he is simply wrong about Interleukin 2. Even before the company sought FDA approval in 1988, the FDA and the National Cancer Institute expanded access in 1987 to Interleukin 2, making it available at NCI-supported clinical and comprehensive cancer centers. Moreover, FDA’s review resulted in a substantial modification in the manufacturing, dosing and patient selection to maximize efficacy and decrease toxicity. Finally, it should be noted that even today the U.S. Pharmacopeia, an independent standard-setting organization, recommends “because of its potential life-threatening toxicities . . . that this medication be used only after careful consideration of risk-benefit.”

More misleading than Driscoll’s factual errors is his general failure to recognize FDA’s real record on drug review and approvals and on making drugs available to patients even before final approval. Since 1987, more than 75,000 patients have had access to drugs before final approval under FDA policy.

As for reviewing and approving drugs, FDA’s performance continues to improve as a result of the 1992 Prescription Drug User Fee Act (PDUFA). Compared with the historical average time of about 27 months for review and approval, FDA reviewed and approved all new drugs approved in 1994 in a median time of 19 months. For drugs reviewed under user fees in 1994, the median time was 13.5 months.

In other words, the FDA is well on its way to the 1997 PDUFA goal of reviewing all drugs in 12 months, and significant new therapies in six months.

JAMES A. O’HARA III, Associate

Commissioner of Public Affairs

FDA, Rockville, Md.