CLSA Continues to Advocate for Action on Bipartisan, Bicameral “Innovation” Initiatives
July 17, 2016
Complementing the efforts of the House Energy & Commerce Committee’s 21st Century Cures Act passed by the full House of Representatives last summer, this spring the Senate Health, Education, Labor & Pensions (HELP) Committee advanced more than a dozen individual bills intended to eventually be combined into a single legislative package to be passed by the Senate, and then go to conference with the 21st Century Cures Act.
Of particular note, the Senate HELP Committee-approved legislation includes a bill to improve and renew the priority review voucher (PRV) program for rare pediatric diseases (S. 1878, the Advancing Hope Act), a bill to establish a program at FDA to expedite the priority review of breakthrough medical devices (S. 1077, the Advancing Breakthrough Medical Devices for Patients Act), and – most reflective of CLSA’s comments submitted to the Committee focused on enhancing public-private research collaborations – a bill aimed at reducing the administrative burdens on scientists at NIH (S. 2742, the Promoting Biomedical Research and Public Health for Patients Act).
Since launching the Innovation for Healthier Americans initiative in January 2015, Chairman Lamar Alexander (R-Tenn.) and Ranking Member Patty Murray (D- Wash.) have struggled to determine a path forward for advancing their innovation initiative through the Senate. Issues that continue to stall movement on the Senate innovation initiative include the concerns voiced by members of the HELP Committee over a lack of funding resources for FDA and NIH to carry out the substantial new responsibilities envisioned by both House 21st Century Cures and the Senate Innovation measures. Senate HELP chairman Alexander has acknowledged that committee Democrats will look to block the legislation unless increased funding for NIH is provided in the package. However, given the difficulty in the current political landscape in finding the off-sets needed to pay for new funding, it remains unclear how increased appropriations would be accomplished.
CLSA had been monitoring the possibility that provisions from the 21st Century Cures legislation could be added to the pending opioids conference report (the Comprehensive Addiction and Recovery [CARA] Act), but unfortunately negotiators on that legislation have since completed their work without the inclusion of any House or Senate innovation initiative bills.
After Congress returns from the summer recess period, only 33 scheduled legislative days will remain in the 114th Congress – and with the current rare pediatric disease priority review voucher program set to expire at the end of September, the timeline for action on these bills is particularly constrained. CLSA continues to strongly advocate in both the House and Senate for swift action on these innovation initiatives to advance biomedical innovation and enhance patient access to innovative treatments and cures.