Food and Drug Administration Revitalization Act

openUnited States· United States Congress· EN

Introduced

10 April 2007

Last action

10 May 2007 · Floor

Status

Held at the desk.

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.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

10 April 2007
Introduced
Introduced in Senate
Source: IntroReferral
10 April 2007
Introduced
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Source: IntroReferral
18 April 2007
Reported
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Source: Committee
24 April 2007
Calendars
Placed on Senate Legislative Calendar under General Orders. Calendar No. 120.
Source: Calendars
24 April 2007
Reported
Committee on Health, Education, Labor, and Pensions. Reported by Senator Kennedy with an amendment in the nature of a substitute and an amendment to the title. Without written report.
Source: Committee
24 April 2007
Reported
Committee on Health, Education, Labor, and Pensions. Reported by Senator Kennedy with an amendment in the nature of a substitute and an amendment to the title. Without written report.
Source: Committee
30 April 2007
Reported
Measure laid before Senate by unanimous consent. (consideration: CR S5270-5303; text of measure as reported in Senate: CR S5270-5294)
Source: Floor
1 May 2007
Floor
Considered by Senate. (consideration: CR S5325-5329, S5332-5362, S5367, S5368-5371, S5372-5379, S5380-5385, S5387-5388)
Source: Floor
2 May 2007
Floor
Considered by Senate. (consideration: CR S5444-5485, S5486-5492)
Source: Floor
3 May 2007
Floor
Considered by Senate. (consideration: CR S5526-5558)
Source: Floor
7 May 2007
Floor
Considered by Senate. (consideration: CR S5634-5651)
Source: Floor
8 May 2007
Floor
Considered by Senate. (consideration: CR S5682-5686, S5689-5707)
Source: Floor
9 May 2007
Floor
Considered by Senate. (consideration: CR S5759-5824)
Source: Floor
9 May 2007
Vote
Passed/agreed to in Senate: Passed Senate with an amendment and an amendment to the Title by Yea-Nay Vote. 93 - 1. Record Vote Number: 157.(text: CR S5773-5822)
Source: Floor
10 May 2007
Floor
Message on Senate action sent to the House.
Source: Floor
10 May 2007
Floor
Held at the desk.
Source: Floor
10 May 2007
Floor
Received in the House.
Source: Floor

Votes

9 May 2007 · Bill Passed · On Passage of the Bill S. 1082 · Bill Passed · Official source

Yes 93 · No 1 · Abstain — · Absent/not voting 6

Showing the first 4 recorded positions. Vote totals above are complete.

Versions

Engrossed in Senate · 9 May 2007 · Download file
Reported to Senate · 24 April 2007 · Download file
Introduced in Senate · 10 April 2007 · Download file

Documents

9 official files

Engrossed in Senate (text)

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Engrossed in Senate (text)
Engrossed in Senate · EN · 9 May 2007
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Engrossed in Senate (PDF)
Engrossed in Senate · EN · 9 May 2007
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Passed Senate amended
summary · EN · 9 May 2007
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Reported to Senate (text)
Reported to Senate · EN · 24 April 2007
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Reported to Senate (PDF)
Reported to Senate · EN · 24 April 2007
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Reported to Senate with amendment(s)
summary · EN · 24 April 2007
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Introduced in Senate (text)
Introduced in Senate · EN · 10 April 2007
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Introduced in Senate (PDF)
Introduced in Senate · EN · 10 April 2007
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Introduced in Senate
summary · EN · 10 April 2007
Open at official source
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Related records

related to → Food and Drug Administration Amendments Act of 2007
amends ← SAMDT 984
amends ← SAMDT 994
amends ← SAMDT 997
amends ← SAMDT 1000
amends ← SAMDT 986
amends ← SAMDT 1027
amends ← SAMDT 996
amends ← SAMDT 995

Showing 9 of 83 related records.

Sources

PoliticalRepo is an index and interpretation layer, not the authoritative legal source.

Official source: https://www.congress.gov/bill/110th-congress/senate-bill/1082
Open data entity: https://api.congress.gov/v3/bill/110/s/1082
us · 110-s-1082 · source updated 21 April 2025