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S. 3807: Enhancing Drug Safety and Innovation Act of 2006

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S. 3807: Enhancing Drug Safety and Innovation Act of 2006

109th Congress · introduced 2006-08-03 · Health · Latest: Committee on Health, Education, Labor, and Pensions. Hearings held. Hearings printed: S.Hrg. 109-850.

federal

Follow this bill, step by step

  1. Where it came from: introduced 2006-08-03 · official record
  2. Who proposed it: Sen. Enzi, Michael B. [R-WY] · what a sponsor is
  3. What happened next: no floor votes in our records yet. Why?
  4. Where it stands now: Committee on Health, Education, Labor, and Pensions. Hearings held. Hearings printed: S.Hrg. 109-850. Not final yet: this can still change. We check for updates every day.
  5. If it becomes law and spends money: follow the money to money laws, then agencies and contracts and grants.

What does this mean?

Official title

Enhancing Drug Safety and Innovation Act of 2006

Plain summary

Enhancing Drug Safety and Innovation Act of 2006 - 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 within the Food and Drug Administration (FDA) the Reagan-Udall Institute for Applied Biomedical Research 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 establish one or more Critical Path Institutes 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 of Health and Human Services, 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 a member of a panel advising or recommending to the Secretary regarding FDA activities to disclose any financial involvements that the member may have. Directs the Secretary to recuse members with a high magnitude of financial involvement.

Congressional Research Service summary (Introduced in Senate), quoted unchanged (nonpartisan). Read the source.

What a vote does

A “Yea” vote

If it passes both chambers and is signed, it becomes law.

A “Nay” vote

If it is not passed, current law stays as it is.

PSI Sci description of the legislative step (not an opinion).

What does this mean? (plain words)

Official text

Enhancing Drug Safety and Innovation Act of 2006

Source: Congressional Research Service summary (Introduced in Senate)

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The strongest published arguments

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Alternatives

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How did my representative vote? · This bill's floor votes

Officials and money

Sponsor: Sen. Enzi, Michael B. [R-WY] · 3 cosponsors

Cost estimate: No cost estimate published yet.

Cosponsors on this site

No linked floor roll calls in our collected records yet. This does not mean the bill has never had a vote. Check the official bill history.

Words on this page, explained (1)
Ballot initiative
A proposed law or constitutional amendment that citizens place on the ballot by gathering enough voter signatures, so voters decide it directly. About half the states allow some form of it.

Plain meanings written from linked sources. All words.

Sources

Record fed-us-cong109-s3807 · catalog fed-us-congress-bills-cong109 · updated 2026-11-15 by psicol fed-bills-cong109