H.R. 5252: Fair Access to Clinical Trials Act

108th Congress · introduced 2004-10-07 · Health · Latest: Sponsor introductory remarks on measure. (CR E1882-1883)

federal

Follow this bill, step by step

Where it came from: introduced 2004-10-07 · official record
Who proposed it: Rep. Markey, Edward J. [D-MA-7] · what a sponsor is
What happened next: no floor votes in our records yet. Why?
Where it stands now: Sponsor introductory remarks on measure. (CR E1882-1883) Not final yet: this can still change. We check for updates every day.
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

Fair Access to Clinical Trials Act

Plain summary

Fair Access to Clinical Trials Act - Amends the Public Health Service Act to prohibit an entity from receiving an award of a grant, contract, or cooperative agreement to conduct a clinical trial to determine the safety or effectiveness of a use of a drug or device unless the entity agrees to: (1) register the trial; (2) provide the results of such trial to the Secretary of Health and Human Services; (3) disclose specified information regarding the trial to the public; and (4) be subject to audits. Requires the Secretary, acting through the Director of the National Institutes of Health (NIH), to establish and operate a databank of such clinical trial information provided to the Secretary. Requires the Director to assign to the National Library of Medicine the primary responsibility for operating such databank. Requires the Secretary to: (1) identify false or misleading information in the databank, correct such information, and make appropriate public notifications; and (2) amend regulations to require institutional review boards to determine the safety or effectiveness of products registered under this Act and deny approval for trials that are not registered. Specifies information required for registration of clinical trials, including information important to clinicians or researchers. Sets forth provisions regarding periodic updates of databank information, submission of results of clinical trials, public disclosure of databank information, and violations of this Act. Amends the Federal Food, Drug and Cosmetic Act to allow exemptions for clinical investigational use of drugs or devices only if such drugs are registered in accordance with this Act.

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

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A “Nay” vote

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

What does this mean? (plain words)

Official text

Fair Access to Clinical Trials Act

Source: Congressional Research Service summary (Introduced in House)

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

Officials and money

Sponsor: Rep. Markey, Edward J. [D-MA-7] · 4 cosponsors

Cost estimate: No cost estimate published yet.

Cosponsors on this site

Janice D. Schakowsky (D-IL)

Sponsor's campaign money: Rep. Markey, Edward J. [D-MA-7] reported raising $6.0 million (2025–2026). Details. Shown for context only; it does not mean any donor supported this bill.

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 (3)

Appropriation: Money a legislature sets aside by law for a specific purpose. Government agencies may spend public money only as it has been appropriated.
Exemption: A rule that removes certain people, property or activities from a tax or requirement.
Rulemaking: The process agencies use to write regulations that carry out laws passed by Congress or a legislature. Usually an agency publishes a proposed rule, takes public comments, then publishes a final rule.

Plain meanings written from linked sources. All words.

Sources

Congressional Research Service summary (Introduced in House)
Congress.gov
Data: GovInfo BILLSTATUS bulk data (Library of Congress), BILLSTATUS-108hr5252.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/108/hr>

Record fed-us-cong108-hr5252 · catalog fed-us-congress-bills-cong108 · updated 2026-11-15 by psicol fed-bills-cong108