Leadership, Layoffs, and Legislation A Timeline of Key Updates Regarding FDA’s Rapid Transformation

Over the past few months, there have been numerous changes within the U.S. Food and Drug Administration (FDA) that keeping up with everything sometimes feels like a full-time job. Many of us don’t have the time or brain bandwidth to keep it all straight and, once we think we are up to date on the latest development, another headline appears with yet another change.

As a quality intelligence professional, keeping up with the FDA actually is my full-time job, at least part of my full-time job. My job consists of surveilling the regulatory world looking for new regulations, guidance documents, trends and general information that could have an impact on our industry. But this year, because of a communication freeze for federal health agencies and the executive order mandating 10 documents be repealed for each one issued, I have been reading fewer regulatory documents from the FDA, and many more news articles about the agency.

For your ease of reference, here is a chronological listing from the news articles, press releases, press conferences, Google searches and LinkedIn posts I have read from November 2024 to April 2025. This snapshot highlights the significant number of changes in a relatively short amount of time, and I acknowledge that additional changes may well occur before this article is published.

Post-Election 2024

Nov. 14— President-elect Donald J. Trump nominated Robert F. Kennedy, Jr., to be the next secretary of the Department of Health and Human Services (HHS). HHS is the parent department of the FDA, making this pick a bit controversial since Kennedy has been an antivaccine proponent for more than 30 years. Upon accepting the nomination, Kennedy said, “I look forward to working with the more than 80,000 employees at HHS to free the agencies from the smothering cloud of corporate capture so they can pursue their mission to make Americans once again the healthiest people on Earth.”

Nov. 22— President-elect Trump nominated Martin A. Makary, MD, MPH, to be the next commissioner of the FDA. Makary is a surgeon, professor, author and medical commentator. His nomination was also somewhat controversial as, during the COVID-19 pandemic, Makary was a regular on Fox News criticizing the FDA.

Recent Actions 2025

Jan. 18— Director of the Center for Drug Evaluation and Research (CDER) Patrizia Cavazzoni, MD, retired from the FDA, citing family obligations as her reason for leaving.

Jan. 20— Trump was inaugurated as the 47th President of the United States of America.

Jan. 20— Robert M. Califf, M.D., resigned from his position as FDA commissioner in accordance with the customary transition to a new presidential administration. In his farewell post on X (formerly known as Twitter), Califf wrote, “I leave with the satisfaction that much has been accomplished, that consumers and patients are better off, because of our staff’s work during my tenure—guiding the regulated industries to do a better job of producing products that improve health while reducing adverse effects. The hard work we have made in terms of structural changes will help us better deal with future challenges. Commissioners come and go, but this workforce is the foundation for much of American health and well-being. You can be sure that I will be cheering them on from the sidelines and looking to help where I can.”

Jan. 21— The Trump administration imposed a freeze on all communications from federal health agencies that affected regulations, guidance documents, announcements, press releases and posts on websites and social media.

Jan. 31— Trump signed an executive order mandating the repeal of 10 existing rules, regulations or guidance documents for every new one issued.

Feb. 13— Kennedy was confirmed as the secretary of the Department of Health and Human Services.

Feb. 15— Probationary employees at the FDA were terminated. Although the exact number of individuals affected was unclear, estimates suggested that approximately 700 employees were impacted, including 220 from the Center for Devices and Radiological Health (CDRH).

Feb. 21— The Center for Biologics Evaluation and Research (CBER) announced the resignation of its deputy director, Celia Witten, MD, PhD. Julia (Julie) Tierney, JD, who previously served as the FDA chief of staff, was appointed as the new deputy director.

Feb. 22— HHS staff were instructed to email their managers and the Office of Personnel Management with a list of five things they accomplished that week. Elon Musk, then-senior advisor to the President, posted on X: “Those who do not take this email seriously will soon be furthering their career elsewhere.” This mandate was later rescinded.

Feb. 24— Several of the terminated probationary employees were given the opportunity to return to their positions, specifically those from the CDHR.

Feb. 28— Kennedy posted a notice in the Federal Register rescinding the policy on “Public Participation in Rule Making (Richardson Waiver).” This change will enable the FDA to issue new guidance and regulations without a commenting period.

Mar. 4— On its website, the Department of Government Efficiency (DOGE) listed the closure of 30 FDA field offices, including the crucial FDA drug laboratory testing site in St. Louis, Mo. This site plays a significant role in assessing the quality of medicines and other products.

Mar. 5— DOGE announced that it would not be closing the 52,000 square foot facility in St. Louis, Mo.

Mar. 10— Trump named Jim Traficant as the new FDA chief of staff. In this role, he will oversee the day-to-today management of the agency and lead agency activities on major initiatives.

Mar. 11— Hilary Perkins was hired as FDA chief counsel. (Keep this information in mind, as it will be relevant on March 14.)

Mar. 13— This was the deadline for the FDA to submit phase one of their Agency Reduction-in-Force and Reorganization Plan to the White House Office of Management and Budget.

Mar. 13— During FDA Commissioner nominee Martin Makary’s confirmation hearing before the Senate Health, Education, Labor and Pensions Committee, U.S. Senator Josh Hawley (R-Mo.) threatened to vote against Makary's confirmation unless FDA Chief Counsel Hilary Perkins resigned.

Mar. 13— A U.S. District Judge ruled that probationary employees who were dismissed due to performance issues should be reinstated.

Mar. 14— Perkins resigned as FDA chief counsel.

Mar. 14— This marked the deadline for accepting the HHS voluntary resignation offer, which included a $25,000 incentive along with eight weeks of pay and benefits. However, the medical review staff were not eligible for this resignation bonus.

Mar. 17— FDA staff resumed full-time, in-person work at the agency’s White Oak headquarters in Silver Spring, Md. Returning employees reported overcrowding issues such as long security-checkpoint lines, limited parking spaces and insufficient office space.

Mar. 18— Probationary workers who were fired in February were reinstated and immediately placed on paid leave.

Mar. 25— Makary was confirmed as the next FDA commissioner in a 56-44 Senate vote.

Mar. 25— Barclay P. Butler, PhD, was named FDA deputy commissioner for operations and chief operating officer.

Mar. 27— HHS Secretary Kennedy revealed plans for a workforce reduction that will impact 10,000 employees, including 3,500 from the FDA.

Mar. 28— Makary was sworn in as the 27^th commissioner of the FDA.

Mar 28— Peter Marks, MD, PhD, director of the CBER, resigned from the FDA. In his farewell letter, he urged Americans to uphold the scientific endeavors dedicated to their well-being. He ended his resignation letter by saying, “My hope is that during the coming years, the unprecedented assault on scientific truth that has adversely impacted public health in our nation comes to an end so that the citizens of our country can fully benefit from the breadth of advances in medical science.”

Apr. 1— Approximately 3,500 FDA staff were fired as part of the HHS reduction-in-force (RIF) action. Inspectors and reviewers were not impacted by the RIF; however, many of the operational staff supporting reviews and inspections were. The layoffs included staff at all levels within the agency and, in some cases, entire departments.

Apr 3— A plan to reorganize the FDA was leaked. The plan proposed to eliminate the product-specific centers and divide the FDA into five competency areas: the Office of Product Evaluation and Regulation, the Office of Inspections, Compliance and Enforcement, the Office of Scientific and Regulatory Policy, the Office of Administrative and Shared Services, and the Office of Strategic Programs and Innovation.

Apr. 8— Partial telework was reinstated for some FDA employees. Their “read and write work output” will be tracked in 15-minute increments to ensure productivity and accountability.

Apr. 14— This was the deadline for the FDA to submit phase two of their Agency Reduction-in-Force and Reorganization Plan to the White House Office of Management and Budget.

Apr. 15— The FDA started looking for contract workers to replace the 50 fired employees responsible for supporting the Office of Inspections and Investigations. These roles were crucial in organizing travel logistics and securing translators for inspectors.

Apr. 15— The FDA requested that the dismissed staff from the Center for Tobacco Products temporarily return to work after realizing they had terminated the entire office responsible for penalizing retailers who sell cigarettes and vapes to minors.

Apr. 17— A leaked copy of the White House budget revealed plans to slash the HHS budget by one-third, from approximately $120 billion in fiscal year 2024 to around $80 billion in fiscal year 2026.

Apr 17— Two senior officials from the Office of Prescription Drug Promotion resigned: Director Catherine Gray, PharmD, and Deputy Director Mark Askine.

Apr. 17— Makary announced a new policy limiting individuals employed at companies regulated by the FDA from serving as members on FDA advisory committees.

Apr. 21— The FDA hired Lowell M. Zeta as deputy commissioner & special counsel for strategic initiatives, Timothy Schell, PhD, as acting director of the Center for Veterinary Medicine, and Craig Taylor as chief information security officer.

Apr. 22— Makary announced in a press conference, “The FDA is taking action to remove petroleum-based food dyes from the U.S. food supply and from medications.” The official press release made no mention of medications.

Apr. 22— At that same press conference, Kennedy responded to a question about the restoration of Freedom of Information Act (FOIA) offices, by saying, “We’re restoring all the FOIA offices and we’re going to make it much easier for people to get the information…We’re going to start a website with all former FOIA requests and the documents that were produced so people don’t have to do it again and again. And we’re going to try to get as close as we can to total transparency in this agency.”

Apr. 24— Alonza Cruse, the director of the Office of Human and Animal Drugs Inspectorate (OHADI), and Nancy L. Rolli, the OHADI deputy office director for strategic oversight, announced their retirement.

Apr. 29— Jeremy Faust, MD, of Inside Medicine, posted his interview in which Makary stated that there would be no reorganization at the FDA. (You can read the interview here: Exclusive: In conversation with FDA Commissioner Dr. Marty Makary.)

As we navigate these unprecedented changes within the FDA, staying informed and adaptable is more crucial than ever. The scope, pace, and nature of these developments—from sweeping leadership transitions to agency-wide reorganizations—mark a pivotal moment in the future of regulatory oversight in the United States. While the agency's direction remains uncertain, its role in shaping the landscape of public health is undeniably vital.