New FY 22 CR extends to February 18; Medical device cybersecurity: a matter of concern.
Top-Line:
New FY 22 Continuing Resolutions extends funding to February 18.
Dr. Califf’s nomination: Senate HELP confirmation hearing not yet scheduled.
The Senate’s busy December schedule.
Medical device cybersecurity: a matter of concern.
Sign-up to attend upcoming Alliance Webinars on cell and gene therapies and nutrition - Dr. Wilson Bryan, Director of Office for Advanced Tissues and Therapies at CBER
on December 6 at 10:00 a.m.; Dr. Susan Mayne, Director of the Center for Food Safety and Advanced Nutrition, discussing FDA's nutrition programs on December 14 at 2:00 p.m.Analysis and Commentary - Surfing and Misplaced Nostalgia
New FY 22 Continuing Resolutions Extends Funding to February 18. After much drama—and a credible threat of a federal government shut-down—Congress adopted an FY 22 Continuing Resolution that extended federal funding through February 18. This was a compromise between Democrats who wanted a December due date and Republicans who wanted the CR to extend well into March. The House vote was 221-212; the Senate vote was 69-28. The President is expected to promptly sign the bill.
The possibility of a shutdown was not off the table until late in the process and would have had a devastating impact on FDA. The alternative—continued funding under a CR—is not particularly good for FDA either, but infinitely better than a shutdown. Under the CR, FDA has only the amount to spend that it did in FY 21 and cannot undertake certain new initiatives. Because Congress is considering boosting FDA’s budget authority (BA; taxpayer funding) by $200 million or more, there is a substantial gap between the agency’s needs and its available funds under a CR.
This week’s Analysis and Commentary (below) discusses the degree to which appropriations bills have always been targets for delay and disruption.
Dr. Califf’s Nomination: Senate HELP Confirmation Hearing Not Yet Scheduled. Dr. Rob Califf’s nomination to be the new FDA commissioner appears to be in the paperwork stage where the committee gathers information about his background and suitability for the position. No hearing has been scheduled. If the hearing is delayed, then a full-Senate confirmation vote is less likely to occur this year. The Alliance’s stated position is to advocate for speedy nomination and confirmation of candidates so that FDA may have Senate-confirmed leadership. We urge the Senate to move as quickly as they can. Meantime, until Dr. Califf is confirmed, Dr. Woodcock will remain the Acting Commissioner.
The Senate’s Busy December Schedule. The Senate calendar is packed, and the Senate may need to be in session much of the month of December. This provides a ray of hope for a confirmation vote this year on Dr. Califf. Three prominent (and contentious) items are up this month: the reauthorization of the National Defense Authorization Act (NDAA); advancing the President’s $1.75 trillion reconciliation legislation; and resolution of the federal debt limit, which, according to Treasury Secretary Janet Yellen, absent Congressional action, may be breached as soon as December 15.
Medical Device Cybersecurity: A Matter of Concern. MedTech Dive has published an in-depth analysis of current issues in medical device cybersecurity and the relative roles of device manufacturers, hospitals, and the FDA. The agency has put a strong emphasis on this area, which was discussed by CDRH Director, Jeff Shuren, during his July 2021 webinar with the Alliance.
Sign-up to Attend Upcoming Alliance Webinars on Cell and Gene Therapies and Nutrition. The Alliance’s next two webinars are on December 6 and December 14. Here are the details:
Dr. Wilson Bryan, Director of the Office for Advanced Tissues and Therapies at CBER
December 6 at 10:00 a.m.
Wilson Bryan, MD, Director of the Office of Tissues and Advanced Therapies (OTAT), is scheduled for December 6 at 10:00 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.
Dr. Susan Mayne, Director of the Center for Food Safety and Advanced Nutrition, Discussing FDA's Nutrition Programs
December 14 at 2:00 p.m.
Susan Mayne, Director of the Center for Food Safety and Advanced Nutrition, is scheduled to discuss FDA nutrition initiatives on December 14 at 2 p.m. The FDA is responsible for fostering good nutrition and effective food safety practices. Nutrition policy is an important FDA functions and Dr. Mayne will be discussing FDA’s nutrition programs and major initiatives. Sign up here.
These events are open to Alliance members and media. If you are not a member and would like to participate, please contact Steven Grossman.