H.R.4598 - Accutane Safety and Risk Management Act108th Congress (2003-2004)
Summary: H.R.4598 — 108th Congress (2003-2004)
Introduced in House (06/16/2004)
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 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.
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.