Accutane
Accutane Safety and Risk Management Introduction
Statement of Congressman Bart Stupak (D-MI)
June 16, 2004
I want to thank everyone for joining me today to introduce this important legislation, the “Accutane Safety and Risk Management Act.” I especially wish to thank my colleagues who are here and who have cosponsored this legislation. Congressman Chris Smith who worked closely with me on this bill, the March of Dimes, and the Crosland family who traveled all the way from Utah to tell their story.
This legislation represents the efforts of many, especially my family, my colleagues, my Congressional staff and the Energy and Commerce committee staff, who have assisted me over the past few years.
Our investigation of Accutane does not end with this legislation but offers us an opportunity to protect the patients, both children and adults, from this powerful and devastating drug.
In October 2000, my family and I went public with our belief that Accutane led to our son, B.J., taking his own life. We were shocked to learn that consumers, including my family, were not told of the psychiatric side effects and were not adequately warned of the severe birth defects caused by Accutane.
Four years ago, my colleagues and I made specific recommendations to be taken by the FDA and the drug manufacturer, Hoffman-LaRoche, to increase public awareness of this powerful drug.
Now, nearly 4 years later and after two FDA Advisory Committee recommendations to establish a mandatory registry of patients, physicians and pharmacies -- mandatory Accutane registry still does not exist.
Quite frankly, I don’t believe the FDA and the manufacturers of Accutane/Isotretinoin will ever implement a mandatory registry, let alone a registry that will inform and protect the American public. That is why it is necessary to introduce this legislation today. If the FDA is not going to act – we will!
My bill is very simple: it creates a mandatory registry for all patients, prescribers, and pharmacies that dispense Accutane and its generics. Right now, we don’t have a registry. Even reporting of Accutane side effects are voluntary for doctors. The informed consent is voluntary. The pregnancy exposure warnings are limited to only female patients.
The scope and depth of Accutane’s serious adverse event reports compiled by the FDA are only a fraction of the actual number of deaths, birth defects and devastation caused by this drug. The true number of Accutane victims and their families are real, and once again the FDA has let us down!
