Genomics and Personalized Medicine Act of 2010
Latest action. Referred to the House Committee on Energy and Commerce.
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.
Written by analysts at the Congressional Research Service and published on Congress.gov, not by Civibrief. Summarized at the "Introduced in House" stage on May 27, 2010. It describes the bill, it is not the legal text.
Where is it in the process, and what happens next?
4 steps remain before this bill could become law.
The record's latest action, on May 27, 2010: Referred to the House Committee on Energy and Commerce.
- Clearing the committees it was referred to, and being scheduled for a floor vote
- Passage by the House
- Passage by the Senate
- The President's signature. If the President vetoes it, two-thirds of both chambers must vote to override.
How likely is it to become law?
Civibrief does not forecast outcomes and this page has no opinion about this one. What the record supports is a base rate, which is a fact about the whole pile, not a prediction about this measure.
In the 111th Congress (2009-10), 383 of the 10,778 bills and joint resolutions introduced became law, about 3.6 percent. That count covers every measure at every stage, including the many that never left committee.
This one is not there yet: 4 steps are still outstanding, listed above.
Has anyone actually voted on it?
No. No roll call in this Congress cites this measure. That is the ordinary outcome: most measures never reach a recorded floor vote, and a committee ends most of them simply by not acting.
A vote is not the only thing that happens to a measure. Hearings, markups, and referrals are all recorded actions, and none of them is a vote of the full chamber.
Who is behind it?
PATRICK KENNEDY (D-RI) introduced it on May 27, 2010, and 6 members have since signed on as cosponsors.
They are 6 Democrats.
Cosponsoring is a formal signature on the text. It is not a commitment to vote for the measure, it does not bind anyone's party, and a long list of cosponsors is a measure of attention rather than of prospects.
How long has it been in play?
It was introduced on May 27, 2010, 5950 days ago. The most recent recorded action was 5950 days ago, on May 27, 2010.
Measures do not carry over. Anything the 111th Congress has not finished by January 3, 2011 dies when the term ends, and has to be introduced again from the start in the next Congress.
Every answer above is assembled from this measure's own record on Congress.gov and from published counts of what Congress has passed before. Civibrief does not predict outcomes and takes no position on any measure.
Vote history
- HouseIn committee, no floor vote yet
- SenateAwaits House passage
- PresidentAwaits both chambers