This Week: Cavazzoni to leave FDA, Trump’s FDA transition team, and more

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation, and what we’re reading from around the web. This week, FDA's top drug regulator announced she's retiring next week, the agency published dozens of new guidances, and it announced public meetings to discuss diagnostics development, rare diseases, and more.

Patrizia Cavazzoni, director of FDA’s Center for Drug Evaluation and Research (CDER), announced she is leaving the agency on 18 January after serving at the center since 2018. She said she has decided to leave the agency to spend more time with her family.

“Leaving CDER was an extremely difficult decision, but the time has come for me to be more present for my family, who have taken the backseat over the past few years due to the demands of my role and our critically important public health work,” she said in her farewell letter to agency staff. “While I am leaving my position at CDER, my commitment and support for all of you and your mission will continue after my departure, and I will continue to do my utmost to support and advocate for CDER and FDA.”

Cavazzoni has served as director of FDA’s drug center since 2020, at first on an acting basis while former longtime CDER Director Janet Woodcock diverter her attention to running Operation Warp Speed as part of the COVID-19 response, then as permanent director in 2021 when Woodcock returned to the agency as acting FDA commissioner. Prior to working at FDA, Cavazzoni held executive positions at Pfizer and Sanofi.

FDA Commissioner Robert Califf also issued a statement to FDA staff praising her achievements as CDER director and highlighted her work to manage the COVID-19 pandemic, the opioid crisis, natural disasters and increasingly complex regulatory environment.

“Simply put, Dr. Cavazzoni has made an enormous difference on our collective behalf,” said Califf. “Her dedication and energy are without parallel, and she has been willing to share her energy, time and expertise in this critical area of public service.”

The commissioner announced that Jacqueline Corrigan-Curay, CDER’s principal deputy center director, will serve as acting CDER director, pending ethics clearance.

Some other top FDA officials have either recently left the agency or announced they will leave before the Trump administration takes the reins, including Jeff Shuren, former director of the Center for Devices and Radiological Health (CDRH) and Namandjé Bumpus, former FDA principal deputy commissioner. Califf is also expected to resign as President-elect Trump has named Marty Makary, a Johns Hopkins surgeon, as his nominee to helm FDA.

Califf spoke to STAT News this week, where he warned about brain drain in the federal government considering some of the policies being floated by the Trump Administration and the people who are being considered for top positions.

“It’s already happening. I mean, we’re seeing an increase in early retirements and loss of good people,” he said. “So I’m worried about it. A lot of people are sticking it out, and I’ve encouraged them to do so.”

STAT News also reported that the Trump transition team has started assembling a cadre of officials who will take key roles in the next administration. Former FDA Commissioner Stephen Hahn is reportedly part of the transition team conducting outreach to recruit officials to the agency.

In other news, the data technology company H1 announced that Hahn joined its board and that it had acquired Ribbon Health, another data technology company.

Following news that Steven Grossman, executive director of The Alliance for a Stronger FDA, would be stepping away from the role at the end of the year, the lobby group announced that Cartier Esham, CEO of Esham Strategies, will serve as its next executive director.

In Congress, Sen. Bill Cassidy (R-LA) has been named chair of the Senate Health, Education, Labor, and Pensions (HELP) committee, which oversees FDA. Several top Republicans are also returning to sit on the committee, including Sens. Rand Paul (R-KY), Susan Collins (R-ME), Lisa Murkowski (R-AK), and Marsha Blackburn (R-TN).

FDA published its summary of diversity action plans received from manufacturers for FY 2023 and FY 2024. In the 2023 Consolidated Appropriations Act, Congress gave the agency the authority to require sponsors to submit diversity action plans for their clinical trials. While regulators have not finalized guidance on the topic, they note that sponsors have already stepped up to share the plans. CDER reported receiving 285 diversity action plans over the past two fiscal years, while both the Center for Biologics Evaluation and Research (CBER) and CDRH reported receiving 30 plans each.

This week, FDA published a torrent of guidances, some of which have been covered individually by this publication. Among the many guidances, the CBER has published two final and three draft guidances on reducing the risk of various transmissible diseases such as Hepatitis B and C, Human Immunodeficiency Virus (HIV), disease agents associated with sepsis, and mycobacterium tuberculosis (Mtb) with human cells, tissues, and cellular and tissue-based products (HCT/Ps).

FDA published three International Council for Harmonization (ICH) guidances, including ICH E11A, E6(R3), and M15. The agency also published final guidances detailing its interim policies for drug compounding from bulk drug substances under sections 503A and 503B of the Federal Food, Drug, and Cosmetic (FD&C) Act.

Over the past couple of weeks, FDA announced it will be hosting a slew of public meetings, including a webinar on investigational use requirements for in vitro diagnostic products (IVDs) on 25 February and a joint two-day meeting of FDA and the National Institutes of Health (NIH) on 27 February to observe Rare Disease Day. FDA's Office of Pediatric Therapeutics (OPT), CDER and CBER will host a 15 May meeting to discuss pediatric drug and biologic development, the agency plans to hold a two-day meeting starting on 27 March to discuss challenges in designing and implementing pregnancy registries, and CDRH plans to host a virtual public meeting on 30 January to update stakeholders on its real-world evidence program.

FDA's General and Plastic Surgery Devices Panel is also planning to meet on 20 February to discuss the risks of dermal fillers with new indications, and the agency is again co-hosting the three-day WCBP Symposium starting 28 January with California Sharing Science Solutions (CASSS) to discuss the effects of manufacturing and analytical technologies on the regulatory field.

Drug & biologics

CBER published its annual list of guidances that it aims to develop over the next year. The list includes guidances on topics such as developing blood collection systems, automated collection of platelets, frequently asked questions regarding cell and gene therapy (CGT) products, and standardizing the electronic submission of marketing information for Bioresearch Monitoring (BIMO) inspections.

FDA published its annual report on new drug therapy approvals. Cavazzoni noted in an agency blog post that CDER had approved 50 new drugs with active ingredients not previously approved by the FDA in 2024, including treatments for Duchenne muscular dystrophy, familial chylomicronemia syndrome, and new treatments for rare cancers. She also noted that it was a record year for biosimilar approvals as the agency approved 18 products.

FDA has issued a statement requiring Pfizer's Abrysvo (Respiratory Syncytial Virus Vaccine) and GlaxoSmithKline's Arexvy (Respiratory Syncytial Virus Vaccine, Adjuvanted) to include a warning about potential risks for developing Guillain-Barré syndrome (GBS). The agency said it conducted a postmarket study based on data from its Vaccine Adverse Event Reporting System (VAERS), which found increased risk of developing GBS after RSV vaccination.

Medtech

CDRH launched an Idea Lab as part of the Home as a Health Care Hub initiative. Over the past year, the center has worked to encourage the development of products that healthcare providers can use to monitor and treat patients at home, which has culminated in the Idea Lab program. It will begin by evaluating how people with diabetes manage their condition with at-home products using Lilypad, a virtual reality program.

CDRH said its Total Product Lifecycle Advisory Program (TAP) pilot has enrolled 63 devices thus far. While the pilot was already open to cardiovascular, neurological, and physical medicine devices, it is now also open to ophthalmic, orthopedic, and radiological devices.

This Week: Cavazzoni to leave FDA, Trump’s FDA transition team, and more

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