What We Learned: A Meeting with CDER Deputy Center Director for Operations Dr. Patrizia Cavazzoni

Top-Line: Given that it has been so hard to reach agreement on the COVID-19 supplemental appropriations bill, it is hard to imagine action on the FY 21 funding bills before October 1. There will need to be a Continuing Resolution, with FY 21 funding considered after Election Day. The Alliance met with senior CDER staff and the meeting is summarized in this week’s Analysis and Commentary.Reminder To Media: Friday Update is on-the-record. Further, we are always available to both our members and media to answer additional questions. What We Learned: A Meeting with CDER Deputy Center Director for Operations Dr. Patrizia Cavazzoni. Every year, the Alliance meets with FDA center directors to ask them about their programmatic and funding priorities, as well as opportunities and challenges. These are, necessarily, small group meetings, but are very helpful in understanding FDA’s resource needs. Earlier this year, we met with CBER Director Dr. Peter Marks (summarized here), CDRH Director Dr. Jeff Shuren (summarized here), and FDA Associate Commissioner for Food Policy and Response Dr. Caitlin Boon (summarized here).This week we had the opportunity to meet with CDER Deputy Center Director for Operations Dr. Patrizia Cavazzoni. She was joined by Office of New Drugs Director, Dr. Peter Stein. A summary of that meeting is in this week’s Analysis and Commentary. We are working with her office to see if we can schedule a larger meeting at which she would meet and answer questions from all interested Alliance members. Hopefully, more details will follow soon.FY 21 Funding Bills Still Possible? Time to Be Thinking About a Continuing Resolution? As we have described over the last several issues of Friday Update (here), the Senate has draft FY 21 funding bills ready. However, there is no agreement between Republicans and Democrats on amendments; appropriators are busy with the latest COVID-19 supplemental funding bill; and it is politically safer for Senate Republicans to take up appropriations bills after Election Day.That is still our view. That means that maneuvering on the Continuing Resolution (CR) might start soon after Congress finishes with the current COVID-19 supplemental. That seems early, but is consistent with the likely pressures on Senate Majority Leader Mitch McConnell to send his 20 Republican incumbent members home to campaign as early as possible. With that in mind, we have suggested that September 18 might be a target for the Senate to finalize a CR and go home.Interestingly, it was reported by Politico that Senate Appropriations Committee Chairman Richard Shelby had hinted at a scenario where the FY 21 funding would be wrapped up into the COVID-19 supplemental legislation. We feel certain that he meant a CR, not doing a 12-bill omnibus on top of an already late piece of legislation. We doubt that Senate Minority Leader Chuck Schumer or House Speaker Nancy Pelosi would agree to this because it would make it easier for Senate Republicans to leave DC to campaign -- even earlier than I have projected.FDA Commissioner Hahn Speaks Out on the Process for COVID-19 Vaccine Approvals. On August 6, the Washington Post published an op-ed (here) by FDA Commissioner Stephen Hahn in which he described the FDA process for reviewing and approving a COVID-19 vaccine. He ended the op-ed:

I can attest that every FDA resource has been, and will continue to be, at the ready to facilitate clinical testing programs, and to review clinical data and manufacturing facilities. I can further provide assurances that any vaccine authorized for widespread use will meet the appropriate standards for quality, safety and efficacy.