Accutane Safety and Risk Management Act

Summary

Accutane Safety and Risk Management Act - Requires the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to withdraw approval within 30 days for the sale of drugs that contain isotretinoin as an active ingredient, including Accutane. Allows the Secretary to approve subsequent supplemental applications for such drugs subject to certain restrictions, including safety reporting. Requires that distribution of such subsequently approved drugs be limited, including by: (1) allowing distribution only directly from manufacturers to pharmacists; (2) requiring pharmacists to register, receive education on side effects, dispense only those prescriptions from physicians at certified treatment centers, and file a statement of compliance; (3) developing educational materials for patients, including monthly questionnaires for patients to monitor the development of adverse side effects; (4) requiring patients to register, receive counseling on the drug, sign a statement providing informed consent for treatment, and undergo appropriate tests; and (5) limiting prescriptions to a 30-day supply with no refills. Specifies conditions for a clinic to be certified as a treatment center for a drug containing isotretinoin, including requiring each practitioner to meet certain conditions, such as requirements for registration, an agreement to prescribe in accordance with this Act, and reporting of adverse events. Requires the Secretary to monitor the distribution of such drugs to determine whether the drug is being distributed in accordance with this Act. Specifies conditions under which the Secretary may approve a drug that contains isotretinoin as an active ingredient for a new use. Requires manufacturers and distributors of isotretinoin to report any information on adverse events associated with the drug to the Secretary. Requires the Secretary to conduct and support studies to explore the effects of isotretinoin on the central nervous system and behavior, including depression, suicide, and violent behavior.

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3 official files

• Introduced in House (text)

  Introduced in House · EN · 16 June 2005

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• Introduced in House (PDF)

  Introduced in House · EN · 16 June 2005

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• Introduced in House

  summary · EN · 16 June 2005

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