Precision Medicine Bill Introduced in Senate

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By Jeannie Baumann

March 18 — A bill to support President Barack Obama's Precision Medicine Initiative was introduced March 17 by the head of the Senate health committee.

The bill (S. 2713) wouldn't impose any additional requirements on top of provisions already in the White House initiative, announced in January 2015 to advance an emerging model of health-care delivery that targets treatments to patient subgroups identified by their genetic makeup . Instead, the bill would encourage the Department of Health and Human Services to establish and carry out the Precision Medicine Initiative “to augment efforts to address disease prevention, diagnosis, and treatment.”

Introduction of the bill by Sen. Lamar Alexander (R-Tenn.), chairman of the Senate Health, Education, Labor and Pensions Committee, comes about three weeks before his committee is scheduled to hold the third and final markup of legislation in a bipartisan effort to accelerate the development of new drugs and devices. Alexander's office hasn't confirmed that the bill will be on the April 6 markup docket, but the chairman's past remarks indicates it's a likely move for the Senate committee.

The Senate's medical innovation agenda is the companion effort to the House-passed 21st Century Cures bill (H.R. 6), which includes language about precision medicine.

Not Confirmed for Markup

Officially, the HELP committee has only confirmed one bill for the April 6 markup as of March 18. But in announcing that bill on the scientific workforce (S. 2700), the committee said it plans to add more legislation to the docket . Alexander also said when announcing the first of the three markups in February that the medical innovation agenda would include bipartisan legislation in support of precision medicine, but no such bill had come before the committee until S. 2713 was introduced .

Alexander's bill includes requirements the HHS already has started to address to:

  • ensure the collaboration of the National Institutes of Health, the Food and Drug Administration and the Office of the National Coordinator for Health Information Technology;
  • comply with existing laws and regulations for the protection of human subjects involved in research, including the protection of participant privacy;
  • implement policies and mechanisms for appropriate secure data sharing across systems that include protections for privacy and security of data; and
  • consider the diversity of the million-person national research study cohort to ensure inclusion of a broad range of participants.
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    The bill also includes language on congressional support for developing new approaches to address scientific, medical, public health and regulatory science issues.

    To contact the reporter on this story: Jeannie Baumann in Washington at jbaumann@bna.com

    To contact the editor responsible for this story: Randy Kubetin at rkubetin@bna.com

    For More Information

    The text of S. 2713 is available at http://src.bna.com/dqr.