Dr. Cavazzoni and Dr. Stein to Address FDA Members and Media on October 16

Top-Line: A Continuing Resolution is on track for a House vote next week and must then pass the Senate before October 1. Growing interest in advanced manufacturing is discussed. Acting CDER Director Patrizia Cavazzoni, MD, and Director of the Office of New Drugs Peter Stein, MD, will present to the Alliance on October 16. This week’s Analysis and Commentary examines polling data that may have consequences for FDA in the FY 22 funding process that will start early next year.Dr. Cavazzoni and Dr. Stein to Address FDA Members and Media on October 16. We are honored that Acting CDER Director Patrizia Cavazzoni, MD and Director of the Office of New Drugs Peter Stein, MD have accepted our invitation to speak at a special Alliance webinar, scheduled for October 16 from 9:30 to 10:30 a.m. To sign-up to participate, please contact Reed Diskey. The event is limited to Alliance members and media. If you are not a member and would like to participate, please contact Steven Grossman.It’s All About Getting Out of Town Without a Shutdown. As the election grows nearer, Members of Congress walk a fine line between their desire to campaign and their obligation to govern. They need a Continuing Resolution to fund government past October 1 until after the election. Most would like a COVID-19 package that would provide relief to their constituents and give them an important accomplishment on which to campaign. Even in less troubled years than 2020, legislative gridlock is not the face Congress wants to show to the world. Yet, according to the Committee for a Responsible Federal Budget, “Congress has only passed all appropriations bills on time in 3 of the last 44 fiscal years" (here).Yes, There Will Be a Continuing Resolution. ​It is certain that the Congress will adopt a CR rather than move forward on regular appropriation bills for all Departments and Agencies, including FDA. Negotiations continue regarding what items might be included in a CR. Action will begin in the House, with the goal of having a draft bill completed by Friday, September 18, and consideration by the full House the week of September 21. They may miss Friday because of negotiating delays, but a vote next week is more certain. The CR is likely to provide funding from October 1 through either December 11 or 18. There are reports that House Democrats have been seeking a February or March end date. If the December date is chosen, the CR might still be extended into the new year, depending on the outcome of the election.Literally, a CR continues FY 20 and thereby ​limits the ability of FDA to take action on new initiatives. As observers, we see this as a limitation that is interpreted strictly. However, we assume that in some instances the agency may be allowed to expand or initiate a new phase of a program by identifying a related FY 20 expenditure.COVID-19 Package Remains in Doubt. As noted above, most Members of Congress who are up for re-election would like to have a COVID-19 relief bill enacted before Election Day. However, Democrats and Republicans remain so far apart on the aggregate spending and priority programs that is unlikely that a compromise will be found. However, this morning’s Politico Playbook (here) lays out how the players could still come together on a deal. Should a compromise be negotiated, Speaker Pelosi has told House members to be prepared to return to DC for a recorded vote. To the best or our knowledge, none of these packages include additional funding for FDA.Confidence in FDA: Poll Illustrates Challenges to the Agency. Polling released this week showed that public trust in FDA is greater than for federal and state governments as a whole (here), but that trust levels for FDA were still uncomfortably low (here). This, and its possible implications for appropriations, are discussed in more detail in This week’s Analysis and Commentary.Advanced Manufacturing: An Increasingly Important Solution. Many medical products are manufactured the same way they were 50 years ago. This is despite many manufacturing innovations that are used in other industries. Advanced manufacturing techniques could bring more medical product production back to the United States, as well as shorten the supply chain on vital medical products. Commissioner Hahn and Deputy Commissioner Shah addressed these opportunities in a recent FDA Voices column, which was also covered by the publication Regulatory Focus.