Genomics and Personalized Medicine Act of 2010
Latest action (27 May 2010): Introduced
What this bill does
This bill, introduced May 27, 2010, by Rep. Patrick Kennedy (D-RI) with Rep. Anna Eshoo, aims to expand federal efforts in genomics and "personalized medicine"—health care that uses genetic and family history information to guide prevention, diagnosis, and treatment. It would create an Office of Personalized Healthcare within the Department of Health and Human Services to coordinate related activities across agencies, develop a long-term research strategy, and report to Congress on progress and on how genetic and genomic tests should be regulated. The bill also authorizes research grants for genomics studies, directs the National Institutes of Health to establish a national biobank of human biological specimens and associated data for research, and creates a grant program to help other organizations build or expand their own biobanks, with attention to privacy protections, informed consent, and inclusion of underrepresented populations. Additional provisions address clinical laboratory oversight, public engagement, an Institute of Medicine study, and related FDA and CDC activities, with funding authorized through fiscal year 2016.
The bill would primarily affect federal health agencies (HHS, NIH, CDC, FDA), researchers, clinical laboratories, and organizations operating biobanks, as well as patients whose genetic data and specimens might be collected for research.
The bill was referred to the House Committee on Energy and Commerce after introduction and did not receive a vote before the 111th Congress ended, meaning it did not become law.
Plain-English summary generated by Bill100 AI from the official record. Always verify against the source below.
Official summary
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.
Common questions
- What does H.R. 5440 do?
- This bill, introduced May 27, 2010, by Rep. Patrick Kennedy (D-RI) with Rep. Anna Eshoo, aims to expand federal efforts in genomics and "personalized medicine"—health care that uses genetic and family history information to guide prevention, diagnosis, and treatment. It would create an Office of Personalized Healthcare within the Department of Health and Human Services to coordinate related activities across agencies, develop a long-term research strategy, and report to Congress on progress and on how genetic and genomic tests should be regulated. The bill also authorizes research grants for genomics studies, directs the National Institutes of Health to establish a national biobank of human biological specimens and associated data for research, and creates a grant program to help other organizations build or expand their own biobanks, with attention to privacy protections, informed consent, and inclusion of underrepresented populations. Additional provisions address clinical laboratory oversight, public engagement, an Institute of Medicine study, and related FDA and CDC activities, with funding authorized through fiscal year 2016. The bill would primarily affect federal health agencies (HHS, NIH, CDC, FDA), researchers, clinical laboratories, and organizations operating biobanks, as well as patients whose genetic data and specimens might be collected for research. The bill was referred to the House Committee on Energy and Commerce after introduction and did not receive a vote before the 111th Congress ended, meaning it did not become law.
- Has H.R. 5440 become law?
- Not yet. As of 27 May 2010, H.R. 5440 is introduced.
- Who sponsored H.R. 5440?
- H.R. 5440 was sponsored by Rep. Patrick Kennedy [D-RI1, 1995-2010] (Democrat-RI), with 6 cosponsors.
- What's the latest action on H.R. 5440?
- Introduced (27 May 2010).
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