Weekly Policy Update: Congressional Drug Pricing Efforts + CBSA Medical Device Symposium
By: Colorado BioScience Association Date: 08/27/2021
H.R. 3 Impact
House Speaker Nancy Pelosi originally released H.R 3, the Lower Drug Costs Now Act in 2019, the Act went on to pass out of the chamber by a slim bipartisan margin where it then faced predicted strong opposition by the GOP controlled Senate. The legislation was reintroduced in the House this past April and rebranded as the Elijah E. Cummings Lower Drug Costs Now Act. As noted in an article originally published in the Washington Examiner earlier this week, H.R 3 is facing an even steeper challenge to pass out of the House this time with a growing cohort of Democrats who supported the initial bill expressing concerns related to the legislation’s intent to address the affordability of medicines.
It is expected that the House Energy and Commerce Committee will take up the bill in the coming weeks, several committee members are among the cohort expressing concerns about the legislation. If the bill survives the House and makes it through to the ever-challenging dynamic of a tied Senate, it would have direct negative impacts on Colorado’s life sciences ecosystem. These impacts were noted by CBSA and our partners at We Work for Health Colorado in a briefing attended by seven congressional offices this past May. These topline impacts include a total Colorado job loss of 8,153 including 1,537 within the biopharma field along with $2 billion in lost state economic output. Learn more about these impacts in CBSA’s one-pager about International Reference Pricing Policies.
CBSA remains concerned about state and federal policy proposals to allow government price setting of medicines. We will continue to work closely with our members and partners to educate policymakers about how these proposals could negatively impact our life sciences ecosystem and the patients we serve. CBSA is committed to advancing affordability solutions that correct market failures, increase competition, and lower costs for patients.
Policy Takeaways from CBSA’s Medical Device Symposium
This week CBSA hosted the annual Medical Device Symposium sponsored by Snell & Wilmer. On day two of the symposium, Brendan Benner with the Medical Device Manufacturers Association (MDMA) provided a comprehensive update on the current federal landscape impacting life sciences. Highlights include:
- CURES 2.0: Colorado Rep. Diana DeGette (D-CD1) along with Missouri Rep. Fred Upton released a draft of CURES 2.0 including important funding for the would-be created Advanced Research Projects Agency for Health or ARRPA-H. However, there is currently not a clear path for the legislation this year.
- FDA Director Appointment: The FDA remains under the leadership of an acting Director with no timetable coming from the administration on the nomination of a permanent Director whose appointment would require confirmation by the Senate.
- Medical Device User Fees: MDMA is in continued negotiations with the FDA for the upcoming Medical Device User Fee Amendments (MDUFA V) program, MDMA has seen increasing interest in the negotiations from members of Congress and the media in recent weeks. The association will continue to work on closing the gap with the administration in several key areas including the investment of carryover balances and ensuring there is an accurate financial baseline for the program.
The symposium gives Colorado medical device leaders the opportunity to discuss trends impacting medtech. Sessions include a special focus on regulatory milestones and an update on federal policy.