FDA Pressured To Act On Acne Drug AccutaneOct 7, 2004 | AP
The Food and Drug Administration is facing renewed pressure from lawmakers to require that patients receiving the acne drug Accutane, health workers who prescribe it and drugstores that dispense it enroll in a national registry.
Four lawmakers including Rep. Bart Stupak, D-Mich., whose teenage son committed suicide while taking Accutane, threatened on Thursday to seek legislation enacting the changes if the FDA fails to act by Nov. 1.
The FDA should "pull this drug until we have more research on the Accutane side effects and the permanency of those effects" on children, the lawmakers wrote Wednesday in a letter to Health and Human Services Secretary Tommy Thompson. It was signed by Stupak, Sen. Gordon Smith, R-Ore., and Reps. Christopher Smith, R-N.J., and Dave Weldon, R-Fla.
Thompson oversees the FDA, which Stupak says has been slow to adopt recommendations from its own advisory committees on the matter. Federal advisers had called for such measures as pregnancy tests for women receiving Accutane and a caution to use two forms of contraception, to avoid birth defects associated with the drug.
Kathleen K. Quinn, an FDA spokeswoman, said Thursday the agency was preparing its response.
The lawmakers seek mandatory tracking of psychiatric events associated with the drug's use, including depression and heightened suicidal thoughts and behaviors, and they want to curb off-label prescriptions responsible for the bulk of Accutane use. It is worth mentioning that the tendency of filing an Accutane lawsuit has been growing rapidly in the US and other territories since many of those who are on the drug face its dangerous side effects.