Controversial Acne Drug Could Get Popped (With More Regulation)

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"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.

Some lawmakers also believe that the FDA and Roche have underestimated Accutane's ability to cause depression and suicide. According to Stupak, his office has determined that over the last two-and-a-half years there have been about two suicides per month that can be associated with Accutane use.

While this does not confirm that Accutane causes depression or suicide, it is ample proof that patients should at least receive additional information concerning these risks, add representatives of the House Committee on Government Reform, which will be hosting the congressional hearing Tuesday.

The hearing is titled "Is Teen Acne Drug Linked to Depression and Suicide?" Besides testimony from experts, the committee is scheduled to hear from family members of teens that committed suicide while on Accutane, as well as federal regulators such as Janet Woodcock, MD, director of the FDA division responsible for prescription drugs.

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