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Bill Calls For Regulating Accutane

Location: Washington, DC

BILL CALLS FOR REGULATING ACCUTANE -- (Extensions of Remarks - July 22, 2004)

Mr. SMITH of New Jersey. Mr. Speaker, I rise in support of H.R. 4598: the Accutane Safety and Risk Management Act.

In an effort to improve the health and safety of patients using a pharmaceutical product that has been linked to several major side effects, I recently joined with my friend and colleague Congressman BART STUPAK of Michigan to introduce this legislation that will establish a comprehensive patient registry for users of the drug Accutane and its generic forms.

Accutane was approved for use in treating severe acne in the early 1980s. Today, more than 1 million prescriptions are approved each year, and not always for the serious cases of acne for which the drug is intended. The Food & Drug Administration states that, "Accutane may cause depression, psychosis, and rarely, suicidal ideation, suicide attempts, and suicide." Additionally, the makers of the drug state that "there is an extremely high risk that a deformed infant can result if pregnancy occurs while taking Accutane in any amount, even for short periods of time."

Four years ago, Congressman STUPAK had to endure the tragic suicide of his teenage son, who was using Accutane at the time of his death.

Despite the fact that the significant and serious side effects linked to 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. Such a registry has been recommended by FDA advisory panels on two separate occasions.

Mr. Speaker, our bill 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.

H.R. 4598 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 by the FDA 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 potential 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 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, that occurs in a patient while using Accutane.

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