WASHINGTON – Today, the Food and Drug Administration (FDA) presented their new pregnancy risk management plan announced in November 2004 to restrict the use of Accutane by pregnant women. Congressman Bart Stupak (D-MI), who has been a fierce critic of FDA’s inaction on Accutane regulation, said the program is lacking several components to meaningfully protect the public’s health.

The new Accutane risk management plan, called iPLEDGE, requires the mandatory registry of all wholesalers, pharmacies, and doctors involved in the distribution and dispensing of Accutane.  It also requires mandatory registry, education, and pregnancy testing for patients prescribed Accutane. 

“In my family’s case and that of over 200 other families that lost a son or daughter since my family and I went public with our concerns about Accutane in October of 2000, the FDA’s proposal is too late,” said Stupak. “However, I’m pleased the FDA is finally going to require strong educational and tracking components to minimize pregnancy exposures after being told to do so for over five years.”

After years of FDA delay on a mandatory registry, Stupak introduced legislation last Congress and again this year to create a registry of patients, providers, and pharmacists.   Stupak’s bill would also require more education for prescribers and patients on the psychiatric effects of the drug.  The bill would also authorize more research on the drug’s psychiatric effects and restrict the use of the drug to treat only the severest form of acne.  Accutane, or Isotretinoin, is a drug that is approved to treat the most severe forms of acne.  However, it has been widely prescribed for mild and moderate skin problems since it went on the market in 1982.  

“While I’m pleased many of my recommendations are included in the new plan, many loopholes and shortfalls still exist that will leave the public at risk,” said Stupak. “The FDA acknowledges that it does not regulate the practice of medicine and therefore has no power or intention to limit the prescription of this drug to just the most severe acne. Off-label use of this drug will remain rampant under this new system.”     

In addition, the plan requires patients to report pregnancy exposures to the FDA, their doctors, and the iPLEDGE system; however, the plan does not require or inform patients of their ability to report other side effects, including psychiatric symptoms, to the FDA. 

The new tracking system will only track pregnancy exposures and will not track other adverse events.  The current FDA adverse events reporting system, MedWatch, only receives two to ten percent of the actual numbers of adverse events reported, according to the FDA. 

“The FDA acknowledges scientific studies that show Accutane’s harmful effects on the brain and they have received thousands of reports of depression, suicidality, and suicide, yet they have taken no meaningful steps to better track this deadly potential side-effect.  The FDA acknowledges that their current system of reporting doesn’t work, yet they failed to take this opportunity to strengthen it,” Stupak said. “The agency cannot continue to claim this drug is safe, while at the same time say Accutane may cause serious psychiatric events, including suicide.”

“Unless there is adequate tracking of the psychiatric effects and further research into the cause of these potentially deadly side effects, the FDA cannot tell the American people it is adequately protecting their health and the health of their children,” said Stupak. 

“Almost a year ago, I and other members of Congress shared a study on PET scans with then FDA Commissioner Lester Crawford that demonstrated how Accutane decreased brain function in some Accutane users,” said Stupak.  “At that time, Crawford estimated that up to 150,000 young people may experience restricted brain function with Accutane use.  Still, the FDA has not addressed this side effect in today’s announcement.  The FDA has claimed that the dosage of Accutane maybe stronger than necessary to treat even the most severe acne, yet the FDA does not require Accutane’s manufacturers to conduct studies to determine the proper dosage of Accutane on young developing brains.  This over dosing may explain why we see PET scans of young developing brains with decreased function in the front part of the brain, the area known to mediate depression.”

Other problems with the program identified by Stupak include that physicians do not have to attest to understanding the psychiatric risks associated with the drug nor does each pharmacist at a registered pharmacy have to register with the program and certify that he or she understands his or her responsibilities.

According to a December 9, 2004, USA Today article, Roche, the maker of Accutane, admits they have estimates that the depression rate is 1.5 times higher among Accutane users. The FDA has received 4,992 spontaneous psychiatric event reports as of August of this year.

For those who have experienced negative effects from taking Accutane or any other prescription drug, it is important that they report those events to the FDA by calling 800-FDA-1088. 

For more information about Accutane and Stupak’s work on the issue, go to www.house.gov/stupak.accutane.htm.

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