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S 2281 112th Congress Senate

ExPERT Act

Official title: A bill to amend the Federal Food, Drug, and Cosmetic Act to strengthen the ability of the Food and Drug Administration to seek advice from external experts reg… Show full official titleShow less

Official title: A bill to amend the Federal Food, Drug, and Cosmetic Act to strengthen the ability of the Food and Drug Administration to seek advice from external experts regarding rare diseases, the burden of rare diseases, and the unmet medical needs of individuals with rare diseases.

Introduced: August 1, 2012 Introduced by: Whitehouse, Sheldon Democratic · Rhode Island See on congress.gov
Health Administrative law and regulatory proceduresDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationFood and Drug Administration (FDA)
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GeneticsMedical researchPublic-private cooperation
This bill died when the 112th Congress ended
It never became law before the 112th Congress (2011–2012) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 2 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Mar 29, 2012
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Mar 29, 2012
Introduced in Senate
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 Latest action March 29, 2012

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

 Plain-English summary Congressional Research Service

Expanding and Promoting Expertise in Rare Treatments Act of 2012 or EXPERT Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS) to ensure that opportunities exist for consultation with external experts to promote the efficiency of and inform the review by the Food and Drug Administration (FDA) of drugs and biologic products for rare diseases and drugs and biologic products that are genetically targeted.

Requires the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research to seek the opinion of external experts on topics that may include: (1) rare diseases; (2) the severity of rare diseases; (3) the unmet medical need associated with rare diseases; (4) the willingness and ability of individuals with a rare disease to participate in clinical trials; (5) an assessment of the benefits and risks, including side effects, of current and investigational therapies; (6) the design of clinical trials for rare disease populations and subpopulations; and (7) demographics and the clinical description of patient populations. Authorizes: (1) external experts to request the opportunity to meet with a review division regarding any such topic, and (2) external experts who are consulted to be considered special government employees.

Declares that nothing in this Act shall be construed to: (1) create a right for any external expert to obtain access to proprietary information of a sponsor without that sponsor's permission or a legal right for a consultation on any matter, or (2) require the Secretary to meet with any particular expert.

 Related & companion bills 1
 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 1
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APA
U.S. Congress. (2026). S. 2281: ExPERT Act. 112th Congress. Open America. https://openamerica.io/bill/112-S-2281/
MLA
"S. 2281: ExPERT Act." 112th Congress, 2026, Open America, https://openamerica.io/bill/112-S-2281/.
Bluebook (legal)
S. 2281, 112th Cong. (2026), https://openamerica.io/bill/112-S-2281/.
Markdown link
[S. 2281: ExPERT Act](https://openamerica.io/bill/112-S-2281/)
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