Advocacy at a Glance

Top-Line: The reconciliation legislation, with substantial money to support FDA’s COVID activities, is advancing, but slowly. HHS Secretary-Designate Becerra faced confirmation hearings this week, but there were only a couple of questions involving FDA, none of them major. A panel and a great infographic on COVID-19 therapies is described. CDRH reached milestones in 2020 in its support of innovation in medical devices. This week’s Analysis and Commentary responds to questions about FDA’s funding needs and the limited history of HHS Secretaries with medical, public health, or scientific training.
 
Reconciliation Bill Likely to Advance with House Passage. As of Friday morning (February 26), the House was on track to pass the COVID relief reconciliation package before the weekend. If that occurs, the Senate will likely start consideration next week. Once the Senate concludes, there is likely to be a House-Senate Conference Committee to resolve differences. The target is still to have the bill on the President’s desk before March 14, the day upon which many existing relief provisions would otherwise lapse.  
 
The Alliance’s interest is in the $500 million in no-year money to support FDA’s COVID-19 efforts. We are optimistic that it will remain in any final version of the legislation. If enacted, it would be by far the largest Congressional acknowledgement of the pressures and costs that the pandemic has imposed on FDA. We thank FDA’s Congressional champions for their continuing support of the agency’s pivotal role in this unprecedented health crisis. This week’s Analysis and Commentary responds to a question about how the COVID monies relate to the funding of FDA’s non-COVID activities.
 
Becerra Confirmation Hearings Reveal Senators’ Priorities. President Biden’s nominee for HHS Secretary, Xavier Becerra, faced both the Senate HELP and Finance Committees this week. While opposition to Becerra has formed, the consensus at week’s end was that he had sufficient support to be confirmed. The Senate Finance Committee is likely to vote next week and a floor vote would be expected soon thereafter.
 
During the Senate HELP Committee hearing (here), most of the focus was on health care costs and coverage, school re-openings, and reproductive rights (as anticipated by Politico here and reported here). As might be expected, there was no discussion of FDA’s budget or personnel needs. We noted three exchanges worth reporting:

• Chairwoman Murray (D-WA) criticized the Trump administration for demanding that FDA authorize unproven therapies. Secretary-Designate Becerra highlighted the need to follow science.
• Sen. Braun (R-IN) asked Becerra if he would acknowledge that the government worked with pharmaceutical companies to rapidly produce COVID-19 vaccines. Becerra stated that the government worked with the private sector to rapidly produce vaccines and would make sure that FDA has learned that vaccines can be rapidly produced in a way that ensures safety.
• Sen. Marshall (R-KS), who is a physician himself, asked Becerra how many doctors and nurses work at HHS. Becerra indicated that some employees at top levels of CDC, NIH, FDA have healthcare and medical backgrounds.

On this last item, we expect that Secretary Becerra will soon have a better sense of how many health professionals and PhDs are required for Public Health Service agencies to fulfill their missions and responsibilities. This week’s Analysis and Commentary responds to a question about whether HHS Secretaries are expected to have medical, public health, or scientific training.

Panel Discusses Range of COVID-19 Therapeutics; FDA’s Role Highlighted in Accompanying Graphic. Compared to vaccines, much less public attention has been given to the development of therapeutic interventions to combat COVID-19. The impressive amount that has been achieved in a year, as well as some troubling access issues, are highlighted in a panel put together by Alliance member Research!America (panel video here). The FDA is a largely uncredited star in the video -- unnamed but essential to almost all the progress that’s described. That omission is more than made up by the infographic that accompanied the panel, which brilliantly documents progress and reflects FDA’s role. We expect that many of our readers will find that graphic to be valuable in their work.
 
FDA Hard at Work: CDRH’s Record 2020 Approval of Novel Devices. FDA Voice features an article (here) on medical device innovation in 2020, authored by CDRH Director Jeff Shuren and CDRH’s Office of Product Evaluation and Quality Director William Maisel. Among the year’s milestones,

FDA approved, cleared, or authorized a record high of 132 novel medical devices in 2020, surpassing the 40-year high set in 2017 and capping off 10 years of progress.

They add:

It is a big leap from the 29 novel devices the FDA authorized a decade ago, in 2010.

Other highlights of 2020 include: creation of the Digital Health Center of Excellence (here) and the increase to over 400 devices now being developed under CDRH’s Breakthrough Devices Program (here).