2015-05-28 13:01:28 UTC

May 29, 2015

The 21st Century Cures legislation is one step closer to a full House vote.

The House Energy and Commerce Committee approved H.R. 6, the 21st Century Cures Act, by a vote of 51 to 0. The bipartisan legislation will:

  • Accelerate the approval process for drugs and devices.
  • Increase funding for biomedical research.
  • Overhaul the FDA approval process to increase the pace at which new therapies are made available to patients.
  • Authorize an additional $10 billion for NIH over the next five years.
  • Increase FDA’s budget by $550 million.
  • Exclude FDA user fees from sequestration.

The $13 billion bill is financed by taking $5.2 billion from the Strategic Petroleum Reserve, $7 billion from Medicare Advantage prescription drug programs, $2.8 in savings from durable medical equipment in the Medicaid program and $200 million from incentivizing patients to utilize digital imaging, as opposed to x-rays, which is estimated to save $200 million.

The House Ways and Means Committee shares jurisdiction over this legislation and needs to conduct its own markup of the bill. House leadership hopes to vote on this legislation by July 4, 2015. However, the legislation, which is a priority for the Republican leadership and Energy and Commerce Chair Fred Upton, R-MI, still needs to go to the Senate, which has not begun work on its version.

The Senate Health, Education, Labor and Pensions Committee (HELP) Chair Lamar Alexander, R-TN, has made it clear that he will not focus on the 21st Century Cures legislation until next year, and that the committee will introduce its own bill as opposed to rubber stamping the House bill. Waiting until 2016 could be challenging given that it is a presidential election year, which usually trumps all major legislative business.

AGA will continue to meet with members of the Senate HELP Committee as they begin to shape their legislation.

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