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United States · Bill · S

S. 1082 (110th)

Food and Drug Administration Revitalization Act

openUnited States· United States Congress· EN

Introduced

10 April 2007

Last action

—

Status

Held at the desk.

Sponsors

—

Subjects

Discovery layer

Source updated

21 April 2025

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Summary

Prescription Drug User Fee Amendments of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to make changes to provisions governing prescription drug user fees. Removes provisions limiting the postmarket safety activities on approved human drug applications to three years after approval of a new drug. Sets forth provisions regarding user fees for human drug applications and supplements that the Secretary of Health and Human Services must collect beginning in FY2008, including the amount of revenue that such fees are to generate and relevant adjustments to such fees. Requires the Secretary to assess and collect fees for advisory review by the Secretary of direct-to-consumer television advertisements for a prescription drug product. Sets forth procedures for such review. Subjects each person that is assessed an advisory review fee to an operating reserve fee for the first fiscal year in which an advisory review fee is assessed. Requires the Secretary to: (1) annually set the fee for advisory review based on the number of direct-to-consumer advertisements that the Secretary will review in the next fiscal year; and (2) establish a Direct-to-Consumer Advisory Review Operating Reserve in the Food and Drug Administration (FDA) salaries and expenses appropriation account to continue such advisory review program in the event the fees collected in any subsequent fiscal year do not generate the fee revenue amount established for that fiscal year. Terminates the program if the Secretary fails to receive a certain amount of advisory review fees and operating reserve fees. Terminates provisions governing prescription drug user fees on October 1, 2012.

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Documents

9 official files

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