Lawmakers urged the Food and Drug Administration yesterday to impose mandatory controls on sale of the prescription acne drug Accutane, but a top agency official told a House panel that such steps could drive use of the drug underground, with more teens trying to buy it illegally on the Internet or from sources in Mexico.
The drug, approved for treatment of severe acne, is a known cause of serious Accutane birth defects and also has generated controversy for its possible association still unproved with depression, suicide and violent behavior in some.
Rep. James Greenwood (R-Pa.), who led a hearing on Accutane by the oversight and investigations subcommittee of the House Committee on Energy and Commerce, asked the FDA why the agency did not impose stricter controls on Accutane beyond the voluntary anti-pregnancy program now in effect.
Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said the agency had told the manufacturer, Hoffmann-La Roche Inc. (Roche) of Nutley, N.J., as well as physicians and pharmacists, that “more stringent and rigorous options” will be explored if the existing anti-pregnancy program does not meet its goals. But she stopped short of endorsing any mandatory registry of Accutane patients, as was proposed by an FDA advisory panel in September 2000. Woodcock said stricter controls could spur more “gray market” purchases of the drug, online or elsewhere, and “end up doing more harm than good.”
Pharmacists dispense Accutane only after receiving certification that the patient has had a negative pregnancy test and meets other criteria, including use of two effective methods of birth control for women who are sexually active.
Susan Ackermann, head of risk management for Roche, said the company has received reports of about 2,300 pregnancies among Accutane users since the drug was introduced in 1982.
Dr. Nancy Green, medical director of the March of Dimes Birth Defects Foundation, called on the FDA to regulate Accutane under the same type of system used for thalidomide, a drug that caused birth defects in Europe in the late 1950s and early 1960s but is now approved in the United States to treat skin sores associated with leprosy. Among the required thalidomide controls, patients must register in a mandatory and confidential outcomes registry to track their progress on the drug. Physicians and pharmacists also must be registered.
The hearing also was marked by sharp questioning by Rep. Bart Stupak (D-Mich.). Stupak’s 17-year-old son, an Accutane patient, died on Mother’s Day in 2000 of a self-inflicted gunshot wound.
George B. Abercrombie, president of Hoffman-La Roche, told the panel “the science has not demonstrated that Accutane causes psychiatric events.” But he said, “We label this medication as if such causation does exist.” Since the label still doesn’t include the information about all possible side effects, one can think over retaining an Accutane lawyer to learn all the options of getting coverage for medical expenses and moral compensation if the link between acne treatment and one’s health problems is proved.