March 11, 2016

House Bill Would Create FDA Breakthrough Pathway

The Senate Health, Education, Labor and Pensions (HELP) committee marked up several bills March 9 addressing biomedical reform, including key provisions of the House-passed 21st Century Cures Act (H.R. 6).

The bills, all passed by voice vote, include legislation that would establish a breakthrough pathway for medical devices, a bill addressing FDA's regulation of combination products and a bill exempting some medical software from FDA oversight. Also approved was legislation adding Zika to the FDA rare disease, priority review, voucher program, a requirement for FDA to document patient engagement in a drug's development and a bill addressing medical countermeasures.

Larger issues pertaining to FDA and NIH funding still present an obstacle to final approval of any large biomedical reform package. HELP committee Democrats want to increase mandatory funding to both the FDA and NIH by $5 billion each year for a decade, while HELP Committee Chairman Senator Lamar Alexander (R-TN) opposes new mandatory funding for FDA.

A third markup is scheduled for April 6. There are no imminent plans for any of these bills to be brought to the Senate floor for a vote in the near future.