Implications far-reaching in FDA approval process

Fueling the firestorm The firestorm over the FDA's drug approval process flared up last November when Dr. David Graham, the reviewer in the FDA's Office of Drug Safety, warned that the nation was facing "the single greatest drug safety catastrophe in the history of this country or the history of the world."

Dr. Graham's comment came during testimony before the Senate Finance Committee that was prompted by the voluntary withdrawal of arthritis drug Vioxx from the market by Merck & Co., Inc. Dr. Graham, who has more than 20 years of service at the FDA, cited the anticholesterol drug Crestor, the pain reliever Bextra, the obesity pill Meridia, the asthma drug Serevent and the acne drug Accutane (Roche), as potentially being unsafe. He said the FDA is far too likely to acquiesce to the demands of drug makers.

"Additionally, an even more rigorous regulatory program is in the process of being developed by the FDA and the manufacturers of isotretinoin with input from the Academy," Dr. Elewski said in her response. "The new risk management program for isotretinoin will be one of the most stringent programs ever developed for a drug sold in the United States."

Damaging effects Noting that the Academy is "playing a positive and crucial role" in the development of the new program by providing information about the clinical experiences of practicing dermatologists, Dr. Elewski cautioned that removal of isotretinoin from the market would be extremely damaging to many acne patients.

"Were this drug to be pulled from the market, severe acne sufferers would lose the most effective treatment for their painful, scarring condition," she says. "It is also very likely that many of these patients would resort to the dangerous and unreliable practice of buying isotretinoin on the Internet. Without dermatologists and other qualified prescribers to manage their therapy, the risk of adverse effects would be increased, rather than diminished, by the withdrawal of isotretinoin from the market."

The guiding principle of dermatologists, Dr. Elewski says, "is to protect the health, safety and welfare of our patients taking this drug while ensuring that it remains available for all patients qualified to take it."

'Irresponsible' Dr. Steven Galso, director of the FDA's Center for Drug Evaluation and Research, later characterized Dr. Graham's warnings as "junk science" and "irresponsible."

"Dr. Graham's congressional testimony does not reflect the views of the Agency," Dr. Gelson says. "The five specific drugs that Dr. Graham identified in his oral testimony are currently approved as safe and effective for use in the United States."

He says the FDA evaluates the safety and effectiveness of all drugs independently on a case-by-case basis before they are approved to enter the marketplace and also evaluates reported adverse events with all drugs already on the market to assess whether unforeseen safety concerns need to be addressed.

Dr. Gelson stressed that the Office of Drug Safety in the Center for Drug Evaluation and Research is "already an independent office" separate from the Office of New Drugs, which reviews new drug applications. Both entities report directly to Dr. Gelson as director of the Center.