Accutane
Safety and Risk Management Act
Background and Legislative Summary
The Isotretinoin Safety and Risk Management Act will create a mandatory program to restrict the distribution of Accutane and its generics, a powerful acne drug that can cause severe birth defects in patients who take the drug while pregnant. The bill is based upon the manufacturer’s own plan but includes additional provisions to protect the health of patients and their children.
Twice in the past four years, FDA Advisory Committees have called for stricter distribution controls, most recently in February 2004. So far nothing has changed. We need to act now.
The Need
The severe birth defects and spontaneous abortions caused by Accutane have been known since its approval in 1982. Four years ago (September 2000) an FDA Advisory Committee recommended a mandatory registry of patients, practitioners, and pharmacists. Rather than act on the Advisory Committee’s recommendations, the FDA approved the current, voluntary SMART (System to Manage Accutane Related Teratogenicity) program, which has failed to reduce the already unacceptably high number of pregnancy exposures.
In February 2004, the Advisory Committee again recommended a mandatory registry. Currently, FDA is working with the manufacturers of Accutane and its generics on a new system, yet there are no deadlines for implementation and no guarantees that the FDA and manufacturers will not once again circumvent the Advisory Committee’s recommendations.
"Exactly how many women have become pregnant while taking the drug is not known. According to the FDA, between 1982 and Dec. 31, 2001, there were 2,261 pregnancies for women who had been exposed to Accutane. Of these, 1,349 chose to abort, 252 had spontaneous abortions, 195 had normal babies, and 167 had babies with birth defects. But these figures don't tell the whole story. Only about 1 in 10 adverse drug effects are reported to the FDA, and agency spokeswoman Kathleen Kolar says that figure could be as low as 1 in 100.” [The Boston Globe 4/11/02]
The adverse psychiatric effects of this drug are also well known. According to the FDA, “Accutane may cause depression, psychosis and, rarely, suicidal ideation, suicide attempts and suicide.” There are now over 235 documented suicides associated with this drug, according to FDA. Patients and parents have a right to know the risks associated with this drug, and this legislation will allow them to make informed decisions.
A Reasonable Approach
This legislation builds upon a plan submitted by Roche, Accutane’s manufacturer, at a February 26-27, 2004 FDA Advisory Committee hearing. However, the Stupak legislation includes additional consumer protections. This legislation directs FDA to approve a program to restrict and manage the prescription of Accutane and its generics within 30 days of enactment, or the drug is removed from the market until a program is approved. The program must include:
- Mandatory registry of all patients, practitioners, and pharmacists.
- Education of practitioners and pharmacists on the risks associated with the drug, including birth defects and mental health risks.
- A requirement that Accutane and generics are only prescribed for severe recalcitrant nodular acne, the medical condition for which Accutane was approved, that is unresponsive to conventional therapy, including antibiotics. Accutane and its generics are often prescribed for mild acne or without trying other medications first.
- Monthly education of patients, both male and female, of the need to avoid pregnancy as well as completion of a survey to warn patients of the adverse side effects. Patient visits will include one-on-one counseling, and patients or parents must sign an informed consent form.
- Certification of medical offices and clinics as treatment centers. No Internet, phone, or mail order prescriptions.
- 30-day prescription allotments.
- Female patients required to have monthly pregnancy test and receive a negative result before renewal of prescription.
- Appropriate blood testing during treatment and 30 days following treatment.
- Yearly evaluation of treatment centers to ensure compliance with program.
- Mandatory quarterly reporting of all adverse reactions and mandatory reporting within 15 days of all patient deaths associated with the drug.
The legislation also directs HHS, CDC, NIH, and National Institute of Mental Health to conduct further studies to explore the effects of this powerful drug.
For more information or to cosponsor this legislation, contact Congressman Stupak or Sonya Wendell of his staff (office line: 225-4735, direct line: 226-0540).
