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The Accutane Safety and Risk Management Act

Location: Washington, DC

THE ACCUTANE SAFETY AND RISK MANAGEMENT ACT -- (Extensions of Remarks - July 14, 2004)

TUESDAY, JULY 13, 2004

Mr. SMITH of New Jersey. Mr. Speaker, I rise today to join with my colleague, Congressman BART STUPAK of Michigan, to introduce legislation that will help improve the safety and health of thousands of Americans who may be using the acne medication Accutane.

Accutane has been documented as causing severe birth defects and miscarriages in pregnant women using the drug, and its side effects can result in the onset of depression, psychosis, and even suicide. Four years ago, my colleague and friend Mr. STUPAK had to endure the tragic suicide of his teenage son, who was using Accutane at the time.

Despite the fact that the significant and serious side effects associated with Accutane are well known, the Food and Drug Administration has yet to mandate a program to better monitor the use of this drug and to document its effects in patients, despite the fact that such a registry has been recommended by FDA advisory panels on two separate occasions.

The Accutane Safety and Risk Management Act is common sense legislation that will build upon a safety plan first proposed by the makers of this drug themselves. It will still permit doctors to prescribe Accutane, but will also institute several additional patient safety and protection measures and ensure patients and their families know the full risks before beginning treatment.

Mr. Speaker, the legislation we propose will permit physicians to prescribe Accutane only for "severe, recalcitrant nodular acne" that has been unresponsive to other forms of treatment. Severe acne is the condition for which Accutane was originally approved to treat. For patients with severe acne, Accutane may be the only medication that can successfully treat their affliction. But in far too many cases, Accutane is prescribed in an overly cavalier manner, and patients are being placed at risk to the drug's side effects for no medically valid reason. Many teenagers suffer from acne, and doctors and patients need to be cautious and not treat this drug lightly.

The legislation will also register all doctors, physicians, and pharmacists who prescribe and dispense the drug, and institute an education campaign to ensure these providers are well-informed about the potential risks associated with Accutane. All patients will also be educated and be required to receive similar information before starting treatment with Accutane and throughout the treatment regimen.

Prescriptions will only be written for 30 days and will not be permitted via the telephone, Internet, or mail. Female patients will also have to undergo a monthly pregnancy test before receiving a renewal on their prescription, and all patients will be required to take a monthly blood test.

The makers of the drug and all practitioners who dispense Accutane will also be required to file prompt reports with the Department of Health and Human Services anytime they learn of a negative reaction, including a death.

In closing, Mr. Speaker, let me just add that I commend my good friend BART STUPAK for having the courage and fortitude to turn a heartbreaking family tragedy into an effort to spare others from suffering a similar loss. I look forward to working with him to advance this important, common-sense health reform.


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