To provide that the approved application under the Federal Food, Drug, and Cosmetic Act for the drug commonly known as RU-486 is deemed to have been withdrawn, to provide for the review by the Comptroller General of the United States of the process by which the Food and Drug Administration approved such drug, and for other purposes.
RU-486 Suspension and Review Act of 2007 - Deems the approved application for the drug mifepristone (marketed as Mifeprex, commonly known as RU-486, and used for the chemically induced termination of intrauterine pregnancy) to have been withdrawn.
Deems the drug misoprostol to be misbranded under the Federal Food, Drug, and Cosmetic Act (FFDCA) if it bears labeling providing that the drug may be used for the medical termination of intrauterine pregnancy.
Directs the Comptroller General to review and report on the process by which the Food and Drug Administration (FDA) approved mifepristone. Provides for the reinstatement of the approved application for such drug if the report determines the approval to have been in accordance with FFDCA.
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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