S 1082 · 110th Congress · Health

Food and Drug Administration Revitalization Act

Introduced 2007-04-10· Sponsored by Sen. Kennedy, Edward M. [D-MA]· Senate

Bill Progress

1
Introduced
Committee
Senate Vote
4
House
5
Enacted
Latest: Held at the desk.(2007-05-10)

Recorded Votes

PassedSenate · 2007-05-09
Roll #157
Yea 93Nay 1
PassedSenate · 2007-05-09
Roll #157
Yea 93Nay 1

Plain Language Summary

[AI summary unavailable — showing source text] 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 Reserv…

Summarized by Claude AI · Non-partisan · For informational purposes only

CBO Cost Estimate

Congressional Budget Office

S. 1082, Prescription Drug User Fee Amendments of 2007

Apr 27, 2007

<p>Cost estimate for the bill as reported by the Senate Committee on Health, Education, Labor, and Pensions on April 24, 2007</p>

Full CBO report ↗

S. 1082, Prescription Drug User Fee Amendments of 2007

Apr 27, 2007

Cost estimate for the bill as reported by the Senate Committee on Health, Education, Labor, and Pensions on April 24, 2007

Full CBO report ↗

Official non-partisan budget analysis by the Congressional Budget Office