Legislative Update; Upcoming Alliance Webinar.
Top-Line:
Former Commissioner Califf nominated to hold FDA post again
The Continuing Resolution expires on December 3: What next?
Build Back Better Bill continues to provide some FDA funding
Upcoming Alliance Webinars - Director of the Office of Tissues and Advanced Therapies (OTAT) Wilson Bryan, MD, December 6 at 10 a.m.; Director of the Center for Food Safety and Advanced Nutrition, Susan Mayne to discuss FDA nutrition initiatives on December 14 at 2 p.m.
Transcript available for remarks By Oncology Center of Excellence (OCE) Deputy Director Paul Kluetz
Keep an eye out for 2022 Dues Invoices from the Alliance for a Stronger FDA
Analysis and Commentary - Time to give thanks to FDA — once again
Former Commissioner Califf Nominated to Hold FDA Post Again. On November 12, President Biden announced the nomination of Dr. Rob Califf to be the next FDA Commissioner. Dr. Califf served as Deputy Commissioner and then Commissioner in the last years of the Obama Administration. As a result of the formal nomination, Acting FDA Commissioner Janet Woodcock can remain at the helm of the agency until Dr. Califf is confirmed.
The Alliance urges the Senate to move quickly to confirmation hearings and a floor vote on the nomination. While we do not take a position on individual candidates, the Alliance has long believed that the FDA should not be without Senate-confirmed leadership for any extended period. When Alliance Executive Director Steven Grossman was asked by reporters about Dr. Califf’s agenda, he expressed his belief that “Dr. Califf’s priorities will have a common theme: FDA modernization. To achieve the greatest benefit for the American people, FDA needs the resources and tools to address the acceleration of medical progress and the potential for a dramatically safer food supply. He will, I predict, advocate for data and technology modernization, improved means of recruiting and retaining FDA employees, facilities upgrades, and the means to make the agency’s processes more efficient, accurate, and responsive.”
The Continuing Resolution Expires on December 3: What Next? Congress cannot have funding agreements and conferenced appropriations bills ready by December 3, when the current CR expires. The much-discussed question in Washington is whether the CR extension would go until later in December (emerging House position) or until a date in February or March (rumored Senate position). There are also some reports of interest in a full-year CR that would end the current impasse. The political appeal of a full-year CR is questionable given that DOD and the defense industry strongly favor the passage of the defense appropriations bills.
We have reported in the past that a CR is not good for FDA since it denies the agency the increases passed by the full House and the Senate Appropriations Committee, prevents the undertaking of some new activities and makes program and staffing decisions particularly difficult.
Build Back Better Bill Continues to Provide Some FDA Funding – Based on a scoring report provided by the Congressional Budget Office, we believe that Section 31203 of the revised House Reconciliation Bill - H.R. 5376, the Build Back Better Act – continues to provide $300 million for FDA infrastructure. The House this morning passed the bill by a vote of 220-213. The measure now moves to the Senate for further consideration and likely amendments.
Upcoming Alliance Webinars. The Alliance is pleased to host FDA leadership to address the Alliance members and media in these upcoming webinars.
Director of the Office of Tissues and Advanced Therapies (OTAT) Wilson Bryan, MD is scheduled for December 6 at 10 a.m. OTAT is the division of CBER that regulates cell, tissue, and gene therapies as well as therapeutic vaccines for various disease indications. Dr. Bryan’s office is at the frontline of guiding and evaluating a rapidly growing portfolio of innovative medical products, many of which are first in class. Sign up here.
Director of the Center for Food Safety and Advanced Nutrition, Susan Mayne is scheduled to discuss FDA nutrition initiatives on December 14 at 2 p.m. FDA is responsible for fostering good nutrition and effective food safety practices. It is one of the most important FDA functions that is not product-based. Dr. Mayne will be discussing FDA’s nutrition programs and major initiatives. Sign up here.
Non-members interested in participating in any of these events should contact Alliance Executive Director Steven Grossman at: sgrossman@strengthenfda.org.
Transcript Available for Remarks by Oncology Center of Excellence (OCE) Deputy Director Paul Kluetz. Earlier this week, we held a webinar with Dr. Kluetz, where he discussed the progress of OCE since it was created nearly 5 years ago. As he described it, the Center engages in a broad range of activities not limited to review of medical products for oncologic and hematologic malignancies and supports. The transcript of his remarks is here and we have also included a summary of the meeting prepared by Roger Szemraj of the Alliance staff.
Keep an Eye Out for 2022 Dues Invoices from the Alliance for a Stronger FDA. The Alliance has now sent 2022 dues invoices to virtually all current members. We choose this time of year because many of our members want to pay their dues from 2021 funds, while others prefer to wait for January 1 and pay from their 2022 budgets. If you have not yet received your invoice, please let Steven or Elisa know.
Giving Thanks to FDA; Next Edition of Friday Update Will Be December 3. This week’s Analysis and Commentary is an update of a past Thanksgiving column and is entitled “Time to Give Thanks to FDA---Once Again.” In that same spirit of thanksgiving and reflection, there will be no Friday Update on November 26 and we will return with a new Update on December 3. Meantime, Alliance staff will be available throughout the next two weeks if you have questions or if we can be of assistance.