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Senate HELP Committee Moves Forward with Companion Legislation to 21st Century Cures

May 05, 2016

The Senate HELP committee has approved the final biomedical innovation bills that form its counterpart to the Cures Act. 
The Senate Health, Education, Labor and Pensions (HELP) Committee has since February been working on a companion bill to the House-approved 21st Century Cures bill.  The committee approved the final biomedical innovation bills that form its counterpart to the Cures Act.  Together with the bills cleared by the in February and March 2016, the panel has now passed 19 bipartisan medical innovation bills. The five newly-approved bills:

  • S. 2700: FDA and NIH Workforce Authorities Modernization Act — to enable the FDA and National Institutes of Health (NIH) attract and retain scientists.
  • S. 185: Promise for Antibiotics and Therapeutics for Health Act — to permit FDA to approve an antibacterial drug for a limited patient population upon determining that the drug treats a serious or life-threatening condition and addresses an unmet need.
  • S. 2713: Advancing Precision Medicine Act of 2016 – to authorize the HHS Secretary to foster interagency collaboration and implement data sharing and other actions to support the President’s Precision Medicine Initiative, which seeks to develop treatments, diagnostics, and prevention strategies tailored to the individual genetic characteristics of each patients.
  • S. 2745: Advancing NIH Strategic Planning and Representation in Medical Research Act – to require NIH to develop a strategic plan to direct NIH biomedical research investments and to ensure that NIH activities take into account women and minorities and focus on reducing health disparities.
  • S. 2742: Promoting Biomedical Research and Public Health for Patients Act — to streamline administrative requirements for NIH researchers and recipients of NIH grants.

Committee staff is now working to assemble those and related bills into a final Cures package. The chair of the HELP committee, Senator Lamar Alexander (R–TN ) has indicated the final bill could be available as early as next week, and said yesterday that Senate Majority Leader Mitch McConnell (R–KY) has agreed to schedule a floor vote on the bill if the committee can produce it.

These legislative developments are positive but an important piece remains unresolved; a Senate agreement on how to increase funding for those agencies, and by how much, is still missing. The House version of 21st Century Cures includes $8.75 billion in so-called mandatory spending for NIH, dedicated money not subject to annual appropriations which would be provided by selling oil from the nation’s Strategic Petroleum Reserve. Republicans initially balked at the idea of mandatory funding but a chorus of Democratic lawmakers on the HELP committee, the loudest among them Senator Elizabeth Warren (D–MA), insisted that no innovation bill would get their support without such funding.

HELP Chair Alexander has been supportive of mandatory funding, but has noted that his committee doesn’t have the jurisdiction to call for selling off petroleum reserves to pay for the spending. Still, he told the committee recently that he was optimistic about devising a funding plan that could win a majority vote in the full Senate. NIH Director Francis Collins later explained in response to a question from Alexander, who also sits on the spending panel, which the agency thinks it could spend such a special fund on five specific areas without facing a “cliff” when the money runs out. NIH could submit a “work plan” with “timetables” and “specific dollar figures,” Collins said.
 

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