Enhancing Drug Safety and Innovation Act of 2007

A bill to amend the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act to improve drug safety and oversight, and for other purposes.

2/1/2007--Introduced.
Enhancing Drug Safety and Innovation Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require an application for approval for a new drug or biological product to include a proposed risk evaluation and mitigation strategy, which must include:
(1) labeling for the drug for use by health care providers;
(2) submission of reports for the drug; and
(3) a statement as to whether the analysis and surveillance are sufficient to assess the serious risks of the drug. Establishes a Drug Safety Oversight Board. Requires the Secretary of Health and Human Services to establish the Reagan-Udall Institute for Applied Biomedical Research as a nonprofit corporation to advance the Critical Path Initiative to modernize medical product development, accelerate innovation, and enhance product safety. Requires the Institute to have a Board of Directors. Allows the Board to coordinate and collaborate with other entities to conduct research, education, and outreach and to modernize the sciences of developing, manufacturing, and evaluating the safety and effectiveness of diagnostics, devices, biologics, and drugs. Amends the Public Health Service Act to require the Secretary, acting through the Director of the National Institutes of Health (NIH), to establish and administer a clinical trial registry database and a clinical trial results database. Requires a responsible part for a clinical trial to submit clinical trial information to the Director for inclusion in the databases. Requires each individual under consideration for a term on an advisory committee providing advice or recommendations to the Secretary regarding FDA activities to disclose industry financial interests.


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Sponsor

• Sen. Michael Enzi [R, WY]
• and 1 Co-Sponsors
  • Sen. Edward Kennedy [D, MA]
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Committees

• Senate Health, Education, Labor, and Pensions

Amendments

This bill has no amendments.

Amendments to S.484

Number	Status	Purpose

Bill Status

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Introduced		Voted on by Senate		Voted on by House		Considered By President		Bill Becomes Law
February 01, 2007

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All Bill Actions

• Mar 14, 2007: Committee on Health, Education, Labor, and Pensions. Hearings held.
• Feb 01, 2007: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
• Feb 01, 2007: Sponsor introductory remarks on measure. (CR S1530-1532)
• Introduced on Feb 01, 2007.
• Feb 01, 2007: Introductory remarks on measure. (CR S1530-1532)

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Related Bills:

• H.R.1561

Related Issue Areas:

• Medical supplies
• Medicine
• Biomedical engineering
• Business
• 39 more
• Clinical trials
• Conflict of interests
• Congress
• Congressional reporting requirements
• Consumers
• Corporations
• Data banks
• Department of Health and Human Services
• Drug approvals
• Drug industry
• Drug interactions
• Drug utilization
• Drugs
• Executive departments
• Executive reorganization
• Federal advisory bodies
• Finance
• Financial disclosure
• Food and Drug Administration (FDA)
• Generic drugs
• Government information
• Government paperwork
• Government publicity
• Health information systems
• Labeling
• Medical care
• Medical instruments and apparatus
• Medical technology
• Nonprofit organizations
• Pharmaceutical research
• Politics and government
• Product development
• Product safety
• Research centers
• Risk
• Science policy
• Social services
• Technological innovations
• Technology

Data from the Congressional Research Service

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In the News

March 08, 2007 Drug safety data need airing, say US researchers

Failing that, it will be down to congressional initiatives such as the Enhancing Drug Safety and Innovation Act (S 484), recently re-introduced by Senators ...

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Source: Pharma Times (subscription), UK

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February 06, 2007 Fears over drug safety risk stalling US user fee legislation

Sen Enzi added that S 484 "will raise the bar to ensure that drug safety is not an afterthought, but an integral part of the process throughout the life of ...

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Source: Pharma Times (subscription), UK

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February 02, 2007 Pharmaceutical Company Misdeeds Being Exposed in Washington

introduced a bill (S 484) that would boost FDA's oversight authority by requiring drug approvals to be paired with programs to manage risk once they reach ...

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Source: SeniorJournal.com, TX

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Blog Coverage

May 03, 2007 May 3, 2007 - DVD-code snafu highlights perils of user-controlled ...

The Enhancing Drug Safety and Innovation Act (S.484) contains provisions that would impose new limitations on advertisers before they can deliver commercial messages to American viewers about prescription medicines. ...

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Source: DUBAI BLOG

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April 26, 2007 April 26, 2007 - Is Shrek too conflicted to promote exercise?

The Enhancing Drug Safety and Innovation Act (S.484) contains provisions that would impose new limitations on advertisers before they can deliver commercial messages to American viewers about prescription medicines. ...

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Source: DUBAI BLOG

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March 27, 2007 Petition Tell Condress:Stand up for patients, not drug companies!

Tell Congress: Stand up for patients, not drug companies! Strengthen S.484 when it gets to the Senate floor for a vote!Dear Senator,You will soon be voting on an extremely important issue to me and m...

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Source: In Loving Memory Of My Son Nick Gentile...

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