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Category: Biomedical Research

House Unveils Zika Funding

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Today, House Appropriations Committee released the House Republicans’ $622 million supplemental appropriations bill to fight Zika. The supplemental is expected to be considered by the House this week.

The bill is fully offset, according to a statement released by the Committee. It uses $352 million in “unobligated” money that was appropriated to address the Ebola outbreak in 2014 and $270 million in “unused administrative funding” from the Health and Human Services Department. Funds would be allocated for FY 2016, which means they could be used during the next five months. House Appropriations Committee Chairman Hal Rogers (R-KY) previously announced that the Committee intends to include Zika funding in the FY 2017 Labor-H bill. 

The proposal is likely to be derided by Democratic Members and the Administration, which have repeatedly called for $1.9 billion in emergency funding without offsets to research and combat the mosquito-borne virus.

 

House Turns to 21st Century Cures

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The House will consider HR 6, the 21st Century Cures Act. The bipartisan bill modifies current federal processes involving medical research, developing drugs and other treatments, and testing and approving those drugs and treatments in an effort to accelerate the development and delivery of cures to diseases and medical conditions. It reauthorizes the National Institutes of Health (NIH) for three years and includes numerous initiatives to promote medical research and attract young scientists, and it reauthorizes Food and Drug Administration (FDA) activities for five years and modifies elements of FDA’s drug and medical device review and approval process to accelerate the approval and distribution of new drugs and medical devices for diseases and conditions that don’t currently have treatments. It provides $9.3 billion in fully offset mandatory spending for a five-year “Innovation Fund” to provide additional funding to the two agencies, with NIH to receive $1.75 billion a year for biomedical research and the FDA to receive $110 million a year for Cures development activities.

The measure has bipartisan and Administrative support.

The House will begin to consider the measure today and pass it by Friday.

21st Century Cures Proposes Funding Increase for NIH

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The latest version of the 21st Century Cures Act was released this morning and the House Energy and Commerce Subcommittee on Health is scheduled to markup the measure on Thursday, May 14th. Like the discussion draft, the updated version provides for an increase in funding for the National Institutes of Health (NIH), both through reauthorization and $10 billion over five years in mandatory funding, starting in FY 2016.

Meanwhile, Senator Richard Burr (R-NC), a member of the Senate HELP Committee, said Tuesday the chamber would draft its own biomedical innovation bill rather than picking up the House’s 21st Century Cures Act. HELP Chair Lamar Alexander (R-TN) said the committee had a goal to get a bill on the floor by early next year but many think that is an overly ambitious timeframe.

21st Century Cures Draft Provides $10 Billion Increase for NIH

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Bipartisan House Energy and Commerce Committee leaders have released a discussion draft marking continued progress in the 21st Century Cures Initiative. The discussion draft is the product of months of bipartisan negotiations and bipartisan staff continues working toward finalized legislation.

The biggest and best provision included in the draft provides for an increase in funding for the National Institutes of Health (NIH), both through reauthorization and $10 billion over five years in mandatory funding, starting in FY 2016.

 The discussion draft also includes provisions to:

  • Incorporate the patient perspective in the discovery, development, and delivery process.
  • Foster development of treatments for patients facing serious or life-threatening diseases.
  • Repurpose drugs for serious or life-threatening diseases and conditions.
  • Modernize clinical trials.
  • Break down barriers to increased collaboration and data sharing among patients, researchers, providers, and innovators.
  • Help the development of personalized and precision medicines so the right patient can receive the right treatment at the right time.
  • Provide for continued work in the telehealth space.
  • Advance a truly interoperable health care system.
  • Provide clarity for developers of software products used in health management and medical care.

A complete section-by-section summary of the discussion draft is available online here and a one-page summary is available online here.