3.0.0 5440 2023-01-11T13:20:06Z 2023-01-11T13:20:06Z House H HR 2010-05-27 111 hsif00 Energy and Commerce Committee House Standing Referred to 2010-05-27T14:12:44Z 2010-05-27 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2010-05-27 Introduced in House IntroReferral Intro-H 9 Library of Congress 2010-05-27 Introduced in House IntroReferral 1000 9 Library of Congress K000113 Rep. Kennedy, Patrick J. [D-RI-1] PATRICK KENNEDY D RI J. 1 N E000215 Rep. Eshoo, Anna G. [D-CA-14] ANNA ESHOO D CA G. 14 2010-05-27 True A000210 Rep. Andrews, Robert E. [D-NJ-1] ROBERT ANDREWS D NJ E. 1 2010-07-13 False P000598 Rep. Polis, Jared [D-CO-2] Jared Polis D CO 2 2010-07-14 False H000712 Rep. Holden, Tim [D-PA-17] TIM HOLDEN D PA 17 2010-07-15 False H000324 Rep. Hastings, Alcee L. [D-FL-23] ALCEE HASTINGS D FL L. 23 2010-07-21 False C001037 Rep. Capuano, Michael E. [D-MA-8] MICHAEL CAPUANO D MA E. 8 2010-07-30 False Health Advisory bodies Department of Health and Human Services Drug safety, medical device, and laboratory regulation Education programs funding Executive agency funding and structure Genetics Government studies and investigations Health care costs and insurance Health information and medical records Health programs administration and funding Health technology, devices, supplies Marketing and advertising Medical education Medical research Medical tests and diagnostic methods Medicare Organ and tissue donation and transplantation Research administration and funding Health 00 2010-05-27 Introduced in House 2010-08-11T20:57:06Z Genomics and Personalized Medicine Act of 2010 - Requires the Secretary of Health and Human Services (HHS) to establish the Office of Personalized Healthcare, the purpose of which shall be to coordinate HHS activities related to genomics and personalized medicine with those of other agencies and entities to ensure that personalized medicine meets the highest standards of safety, efficacy, and clinical validity and utility.

Sets forth provisions related to the collection of genetic and genomic data, including providing for a national biobank.

Requires the Secretary, acting through the Director of the Centers for Disease Control and Prevention (CDC), to establish the Committee on the Evaluation of Genomic Applications in Practice and Prevention.

Directs the Secretary to: (1) improve genomics and personalized medicine training; (2) establish a committee to examine barriers to personalized medicine product development; and (3) review billing, coverage, and reimbursement methodologies for personalized medicine products and services.

Requires the Secretary, acting through the Administrator of the Centers for Medicare & Medicaid Services (CMS) and the Commissioner of Food and Drugs (FDA), to: (1) establish a committee to carry out a comparative analysis of laboratory review requirements; (2) facilitate the use of personalized medicine products to assess the risk for and reduce incidence of adverse drug reactions; and (3) include personalized medicine products in adverse event reporting systems.

Authorizes the Secretary, acting through the Commissioner, to require the sponsor of a drug or biological product to: (1) develop a companion diagnostic test under certain circumstances; and (2) conduct additional postmarket studies of drugs shown to be more or less effective in certain racial and ethnic subpopulations.

Requires the Commissioner to collaborate with the Federal Trade Commission (FTC) to identify and terminate advertising campaigns that make false, misleading, deceptive, or unfair claims about the benefits or risks of personalized medicine products.

Requires the Director of CDC to: (1) expand efforts to increase awareness about genomics and personalized medicine; and (2) analyze marketing of personalized medicine products for which consumers have direct access.

]]> Genomics and Personalized Medicine Act of 2010 Display Title Genomics and Personalized Medicine Act of 2010 Official Title as Introduced To secure the promise of personalized medicine for all Americans by expanding and accelerating genomics research and initiatives to improve the accuracy of disease diagnosis, increase the safety of drugs, and identify novel treatments, and for other purposes. Introduced in House IH Short Titles as Introduced Genomics and Personalized Medicine Act of 2010 Introduced in House 2010-05-27T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-111hr5440ih/xml/BILLS-111hr5440ih.xml 2010-05-27 Referred to the House Committee on Energy and Commerce. 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.