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HR 4156 112th Congress House

EXPERRT Act of 2012

Official title: 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 … Show full official titleShow less

Official title: 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: June 21, 2012 Introduced by: Markey, Edward J. Democratic · Massachusetts 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 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Mar 9, 2012
Referred to the Subcommittee on Health.
Mar 7, 2012
Referred to the House Committee on Energy and Commerce.
Mar 7, 2012
Introduced in House
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 Latest action March 9, 2012

Referred to the Subcommittee on Health.

 Plain-English summary Congressional Research Service

Expanding and Promoting Expertise in Review of Rare Treatments Act of 2012 or EXPERRT Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS) to establish a program for consultation with external experts to inform and strengthen the Food and Drug Administration's (FDA's) review of drugs and biologic products for rare diseases and drugs and biologic products that are genetically targeted.

Requires, under such program, each review division within 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. Allows external experts to request the opportunity to meet with a review division regarding any such topic. Authorizes the Secretary to determine the timing of each consultation, which may occur prior to, or following, the filing of an investigational new drug application, a new drug application, or a biologies license application.

Requires the experts consulted to be considered special government employees.

 Related & companion bills 1
 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 2
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 4156: EXPERRT Act of 2012. 112th Congress. Open America. https://openamerica.io/bill/112-HR-4156/
MLA
"H.R. 4156: EXPERRT Act of 2012." 112th Congress, 2026, Open America, https://openamerica.io/bill/112-HR-4156/.
Bluebook (legal)
H.R. 4156, 112th Cong. (2026), https://openamerica.io/bill/112-HR-4156/.
Markdown link
[H.R. 4156: EXPERRT Act of 2012](https://openamerica.io/bill/112-HR-4156/)
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