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Controversial Acne Drug Could Get Popped (With More Regulation)

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At present, Roche already is phasing in a Targeted Pregnancy Prevention Program directly aimed at those women who, for whatever reason, fail to comply with the mandatory pregnancy prevention provisions required under the prescription. Roche also has prepared a checklist for doctor and patients, which includes a 24-hour contraceptive counseling hotline. And the company has begun shipping pregnancy tests to physicians and now plans to send marketing representatives to about 97% of the prescribing doctors as well.

The FDA has yet to act on the panel's recommendations for Accutane. But the agency recently has taken a number of actions to ensure the proper use of other controversial drugs that, in one instance, eventually resulted in the drug's withdrawal.

The FDA recently attempted to restrict the distribution of Glaxo Wellcome's Lotronex (alosetron), a treatment for irritable bowel syndrome. Lotronex has been associated with 49 cases of a rare, but potentially serious side effect called ischemic colitis. But rather than accept the FDA's proposed restrictions, the British drug maker decided to withdraw the drug voluntarily, saying that the agency's proposed restrictions were equivalent to a withdrawal.

Experts caution that restricting Accutane to only a set of registered pharmacies and physicians could in effect lead to a similar result.

"As dermatologists, we strongly believe that limiting access to [Accutane] is a disservice to patients and erodes the patient-physician relationship," said Richard Scher, MD, president of the American Academy of Dermatology (AAD), following the FDA panel meeting in September. "Education, not regulation, is the key to safe use of this drug to protect women of childbearing age."

"It's not workable," adds David Pariser, MD, FACP, chief of dermatology at the Eastern Virginia Medical School in Norfolk. A registry of all the doctors and pharmacies that need access to Accutane simply would be impossible to generate and maintain, he argues.

Pariser, who will appear at the congressional hearing as a representative of the dermatology association, adds that a registry could drive patients to seek Accutane by other means. "Our fear is that patients will turn to the Internet" and other unreliable sources to get the drug, he tells WebMD.

The American Medical Association (AMA) may soon back the AAD's position. At the AMA House of Delegates interim meeting, currently underway, the AAD is lobbying for the AMA to support encouraging the FDA to seek educational, not regulatory, solutions. The proposed mandatory registry would erode the relationship between patients and their physicians and diminish patient confidentiality, the AAD proposal warns.

But certain influential citizen groups already are uniting in favor of the restrictions. "It is inexcusable that the company has gone for so long without restricting the use of Accutane," says Sidney Wolfe, MD, a director of the consumer watchdog group Public Citizen, the group influential in getting the controversial diabetes drug troglitazone (Rezulin) off the market earlier this year.

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