Congressional Seal
Seal of the State of Michigan

Accutane

Response of Congressman Bart Stupak (D-MI) to FDA Accutane Advisory Panel Recommendations
February 27, 2004

Three years ago, an FDA advisory panel made similar recommendations, but the FDA and Roche failed to implement them. This cannot happen again. I will keep their feet to the fire to immediately implement a mandatory and comprehensive program. For 22 years we have seen the horrific effects this drug has had on women and children. I’m pleased the committee sent a strong message to the drug companies and the FDA that this has got to stop. Unfortunately, the FDA and Roche have ignored past recommendations. That’s why I intend to introduce legislation to ensure that the current toothless voluntary program is replaced with a mandatory and comprehensive registry that includes all patients, prescribers and pharmacists.