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