3.0.0 2281 2020-02-10T17:00:03Z 2020-02-10T17:00:03Z Senate S S 2012-03-29 112 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2012-03-29T21:43:17Z EXPERRT Act of 2012 112 4156 HR 2012-03-09 Referred to the Subcommittee on Health. Related bill CRS 2012-03-29 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2012-03-29 Introduced in Senate IntroReferral 10000 9 Library of Congress W000802 Sen. Whitehouse, Sheldon [D-RI] Sheldon Whitehouse D RI N S000033 Sen. Sanders, Bernard [I-VT] Bernard Sanders I VT 2012-08-01 False Health Administrative law and regulatory procedures Department of Health and Human Services Drug safety, medical device, and laboratory regulation Food and Drug Administration (FDA) Genetics Medical research Public-private cooperation Health 00 2012-03-29 Introduced in Senate 2012-06-25T19:51:32Z 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.

]]> ExPERT Act Short Titles as Introduced ExPERT Act Short Titles as Introduced Expanding and Promoting Expertise in Rare Treatments Act of 2012 Display Title ExPERT Act Official Title as Introduced 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 in Senate 2012-03-29T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-112s2281is/xml/BILLS-112s2281is.xml 2012-03-29 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.