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Accutane called "a 20-year regulatory failure by the FDA" by FDA scientist

-November 21, 2004

A congressional hearing convened to review the FDA and Merck & Co's handling of Vioxx also put the spotlight on safety issues regarding five other drugs, including Accutane. Accutane is a powerful acne drug that has been used by more than six million people in the U.S. Although Accutane was FDA approved nearly 22 years ago, Hoffmann-La Roche's drug has been the source of controversy and scrutiny ever since it has been on the U.S. market.

David Graham, an FDA scientist, described Accutane as "a 20-year regulatory failure by the FDA." The acne medication can cause miscarriage and birth defects when taken by pregnant women. Even with the risk-management system SMART (System to Manage Accutane-Related Teratogenicity), which did not go into effect until 2000 to better manage Accutane's safety issues in women, Graham said the system has not been adequate, saying "In my view, SMART was dumb."

In February, experts working with the FDA recommended Hoffmann-LaRoche and companies making generic versions of Accutane do more to protect patients from safety problems, especially pregnant women. An agreement with Celgene, a biotechnology company, to license parts of a safe distribution system could be reached soon, requiring pharmacists to receive documentation showing a woman has taken a pregnancy test before prescribing Accutane. The system would also establish a registry with the names of physicians and pharmacists prescribing the drug and the patients who are using it.

For more information on accutane, please contact us.

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