FDA Names Chief Scientist Bumpus as Dr. Woodcock’s Successor
FDA Names Chief Scientist Bumpus as Dr. Woodcock’s Successor. Dr. Bumpus, currently FDA’s Chief Scientist, will take on the role of Principal Deputy Commissioner in early 2024. Bumpus, a former Johns Hopkins professor, named “creating a new model” for the FDA’s Office of Regulatory Affairs as one of her priorities when she steps into the role next year.
FDA Commissioner Dr. Califf’s all-staff email regarding the announcement can be found here.
After the announcement, Alliance Executive Director, Steven Grossman wrote to Dr. Bumpus: “The Alliance for a Stronger FDA congratulates you on your appointment. Those are big shoes to fill….but we know you are up to the challenge and will succeed. You do make the FDA stronger.”
Those who have participated in our Alliance Webinar Series have already heard from Dr. Bumpus in August and understand why she is on the fast track. See FDA Chief Scientist Namandjé Bumpus’ August webinar summary here and transcript here.
No Appropriations Action This Week. Neither the House nor the Senate took action on any appropriations measure this week. Senate Majority Leader Schumer (D-NY) in a Dear Colleague letter says he intends to bring the President’s national security supplemental package to the floor as soon as the week of December 4th. This bill is expected to provide funding for Ukraine, Israel, the Indo-Pacific region, and humanitarian assistance. However, this bill is not likely to move until there is a resolution of border security issues.
Uncertain Outlook For Full-Year Funding. Leader Schumer also said that there have been ongoing discussions over the past week to ensure Congress is well-positioned to finish full-year funding bills early next year. He specifically called out the need to complete the first tranche of bills - Agriculture, Energy and Water, Military Construction-VA, and Transportation-HUD - before the January 19 deadline.
Senate Appropriations Chair Patty Murray (D-WA) has little interest in negotiating the fiscal 2024 topline funding levels, saying that House Republicans need to accept the overall funding totals set by the Fiscal Responsibility Act (FRA).
House conservatives continue to argue for lower spending levels. Roll Call reports that Congressman Chip Roy (R-TX), the policy director of the Freedom Caucus said Speaker Johnson should reject an extra $54 billion in nondefense spending negotiated during the debt limit talks that would be funded on top of regular discretionary limits.
However, The Hill reports that Freedom Caucus Chair Scott Perry (R-PA) yesterday said that the spending levels agreed to as part of the FRA, the debt limit deal brokered between President Biden and then-Speaker Kevin McCarthy (R-CA) earlier this year that included budget caps, have “to be the limit” in talks. “It’s still too much for many of us, but [what] was agreed to around Memorial Day was this FRA number of $1.59 trillion. No more gimmicks: Most of the House voted for it; most of the Senate voted for it. That’s where we have to be. Let’s write the appropriations bills. Let’s get the spending bills right. Let’s set that as the number, and then when we do that, let’s start conferencing bills.”
Upcoming Webinar on Gene Therapy with FDA’s Director of CBER, Dr. Peter Marks, December 4th at 1pm ET. Please register here! As the Director of CBER, Dr. Marks’ leadership and vision are central to the development of gene therapies. For this webinar, Dr. Marks is going to present an overview of some of the current challenges and provide his perspective on how the field can move toward greater success and increased patient benefit.
This will be Dr. Marks’ second time speaking at the Alliance Webinar Series in 2023; he discussed CBER’s FY24 Budget in April. You can find a summary and transcript of his April webinar, along with the rest of the Alliance Webinar Series, on our website here.
Board members Ron Bartek (Friedreich's Ataxia Research Alliance) and Cynthia Bens (Personalized Medicine Coalition) will be the co-moderators.
FDA Regulatory Pathways Discussed at House Health Subcommittee Hearing on Artificial Intelligence (AI). The House Committee on Energy and Commerce – Health Subcommittee held a hearing on Wednesday, November 29, 2023 entitled “Understanding How AI is Changing Health Care.”
Although FDA was not the main focus, there were several exchanges involving the agency:
Regulatory pathways for AI came up multiple times during the hearing. When asked about gaps in current regulation, Mr. Peter Shen from Siemens Health noted that the FDA provides several pathways for AI solutions to receive approval. However, he stated that as AI technologies rapidly change, it is important the FDA does not overly restrict these pathways and thereby inhibit innovation.
Drug development using AI was briefly discussed between Congressman Morgan Griffith (R-VA) and Dr. Benjamin Nguyen, Senior Product Manager of Transcarent. Dr. Nguyen explained that AI can assist with many parts of the complex drug development process, from optimizing clinical trial design and patient recruitment to streamlining regulatory paperwork. He pointed out the potential for AI to help pharmaceutical companies identify new treatment approaches more efficiently.
Pre-Certification Program for Medical Devices (PDCP) was also mentioned. Congressman Michael Burgess (R-TX) asked Mr. Shen to describe PDCPs, which allow companies to update approved AI-based medical devices without needing to resubmit applications to the FDA for each change. Mr. Shen said PDCPs help accelerate the development of AI technologies used in healthcare by providing transparency on software modifications while reducing regulatory burdens. He thanked Congressman Burgess and the committee for their work passing legislation authorizing PDCPs.
AI was the primary topic in September when the Alliance hosted FDA Acting Assistant Director of Digital Health Policy MiRa Jacobs, PhD (summary here; transcript here).