House of Representatives appears close to passing the 21st Century Cures Act.

  • On May 21, 2015, the House Energy & Commerce Committee voted unanimously to to advance the 21st Century Cures Act (H.R. 6), a bill that its sponsors say would help accelerate the discovery, development, and delivery of life-saving and life-improving drugs and devices.
  • As detailed in the committee’s press release, the legislation would remove barriers to sharing heath data generated in research and clinical settings; strengthen FDA’s ability to incorporate patients’ perspectives in the drug development and approval process; advance personalized medicine by promoting tools such as biomarkers; modernize clinical trials to produce results faster and at less cost; remove regulatory uncertainty with regard to medical apps, provide new incentives for the development of drugs for rare diseases; create a coordinating mechanism to facilitate connections between scientific discovery, drug and device development, approval, and delivery to patients; and create an “Innovation Fund” that would provide $2 billion per year for five years to fund these initiatives.
  • Under the leadership of Reps. Pitts (R-PA) and Upton (R-MI), the legislation has attracted the support of more than 140 members of Congress, as well as a number of industry stakeholders and patient advocacy groups, but the likelihood of its enactment depends, in large part, on how quickly the bill is advanced; as election season approaches, support for and interest in such bipartisan efforts is expected to erode.  Committee and leadership staff expect the bill will come to the floor following the House’s Independence Day recess; in the interim, staff are racing to adjust the bill’s cost offsets to ensure its passage; the Congressional Budget Office’s estimate, released June 23, 2015, puts the cost at $872 million.