Stupak Proposes Accutane Limits
Bill targets acne drug in push for controls after son's suicideJun 16, 2004 | Detroit News
U.S. Rep. Bart Stupak, whose teenage son committed suicide in 2000 while taking Accutane, will introduce legislation today to tighten control over the controversial acne drug.
Stupak, D-Menominee, wants to require patients to sign a consent form that details risks, without which doctors and pharmacists couldn't prescribe and dispense it. He also wants a mandatory registry of users, prescribers and dispensers of the drug, which is known to cause Accutane birth defects when taken by pregnant women.
Stupak and other critics also charge that the drug can prompt users to commit suicide. Drugmaker Hoffmann-La Roche Inc. disputes the alleged link to severe depression and suicide, although the company alerts users to such possible psychiatric reactions in its product insert.
“We are waiting for the (Food and Drug Administration) and Roche to come up with a final agreement (on tighter controls). That could take forever,” Stupak said in explaining why he is introducing the bill.
In the wake of his son's suicide, Stupak has called for the Accutane recall. His wife, Laurie, is among users and surviving family members who filed an Accutane lawsuit over Roche, claiming the acne drug caused debilitating depression or suicide.
While the first suicide by an Accutane user was reported two years after the drug went on the market in 1982, it wasn't until the suicide of Stupak's 17-year-old son that worldwide attention focused on drug. B.J. Stupak was the president-elect of the student council at Menominee High School when he shot himself during a sleep- over party at his family home.
Roche spokeswoman Carolyn Glynn said the company and three generic manufacturers of Accutane are working with the FDA to implement a mandatory consent form and registry.
“All of these things have been on the label,” Glynn said. “The difference is in linking in a mandatory way the patient, the physician and the pharmacist. We are going to connect all the players to leave no room for error. I have no concern that this won't happen.”
Stupak is also calling for men to be warned that their use of the drug may cause birth defects. Roche maintains birth defects cannot be transmitted by male Accutane users.