The New Normal at the FDA Personnel Changes, Priority Vouchers and a Listening Tour

After months of near silence from the U.S. Food and Drug Administration (FDA), communications are again flowing.

A timeline of events May–July 2025

Since the beginning of May, there has been a steady stream of FDA guidance documents issued, agency staff speaking at conferences, and a new addition to the FDA communication toolkit, FDA Direct.

Although the updates from the FDA appear to have resumed a more normal cadence, there have been plenty of interesting agency updates to keep those of us in the world of quality regulatory intelligence busy. Over the past three months, there have been additional personnel changes to keep track of, executive orders from the President to follow, and a new voucher program from the commissioner to figure out. These updates underscore the importance of closely monitoring the changes within the FDA to ensure we can continue executing our work with quality and following all regulatory requirements and expectations.

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

May 2025

May 2025

May 1 – FDA staff responsible for handling Freedom of Information Act (FIOA) requests were notified that they would no longer be included in the department’s mass layoffs. This came days after a press conference where HHS Secretary Robert F. Kennedy, Jr. (RFK Jr), vowed to restore all FOIA offices.

May 5 – President Donald Trump issued an executive order designed to promote domestic manufacturing. The order instructs the FDA to reduce the amount of time it takes to approve domestic pharmaceutical manufacturing plants and increase fees for and inspections of foreign manufacturing plants. The executive order also instructs the Environmental Protection Agency (EPA) to expedite the development of facilities intended to produce prescription drugs, active pharmaceutical ingredients, and other essential raw materials.

May 6 – In a press release, the FDA announced plans to broaden its practice of conducting unannounced inspections at overseas facilities “to ensure that foreign companies will receive the same level of regulatory oversight and scrutiny as domestic companies.”

May 6 – Vinay Prasad, MD, MPH, a practicing hematologist-oncologist, was appointed as the director of the Center for Biologics Evaluation and Research (CBER). Like other newly appointed top health officials, during the pandemic Prasad was very vocal in his criticism of the COVID-19 vaccine and mask mandates.

May 8 – The FDA launched its new communication tool, FDA Direct. As described by FDA.org, FDA Direct is a podcast where “Commissioner Makary and other members of FDA leadership, as well as guests, engage in timely and frank discussions to bring you an inside look at the current happenings at the FDA.”

May 12 – President Trump signed an executive order establishing the Most-Favored-Nation Pricing, directing pharmaceutical manufacturers to bring prices for American patients in line with comparably developed nations.

May 14 – After 34 years at the FDA, Michael Rogers, associate commissioner for the Office of Inspections and Investigations (OII), formally the Office of Regulatory Affairs (ORA), retired.

May 16 – The Make America Healthy Again (MAHA) Commission’s report, titled “Making Our Children Healthy Again,” was released. The 73-page report outlined the potential dietary, behavioral, medical, and environmental factors contributing to the declining health of children in the United States. A significant emphasis was placed on eliminating potentially harmful substances from food, highlighting additives such as food colorings, titanium dioxide, and butylated hydroxytoluene. It did not address the presence of these ingredients in pharmaceuticals, but as you will read in May 29, pharmaceutical ingredients are in scope of the MAHA initiative.

May 19 – Elizabeth Miller, PharmD, was named acting associate commissioner of the OII.

May 23 – President Trump issued a new executive order “Restoring Gold Standard Science.” This EO states that the current administration is “committed to restoring a gold standard for science to ensure that federally funded research is transparent, rigorous, and impactful, and that federal decisions are informed by the most credible, reliable, and impartial scientific evidence available.”

May 27 – During an appearance on the "Ultimate Human" podcast, RFK Jr stated that he would consider barring government scientists from publishing in leading medical journals, which he described as “corrupt” and subject to the influence of pharmaceutical companies.

May 28 – The FDA announced its CEO Listening Tour to meet directly with pharmaceutical and biotech CEOs. According to fda.org, the aim is to gather direct input on how the FDA can “modernize its regulatory framework to better support innovation and patient access to safe and effective therapies.” The forums will be led by Commissioner Makary, along with the directors of CBER and CDER.

May 29 – Several news outlets reported that the MAHA report contained incorrect citations and even references to studies that didn’t exist.

May 29 – As part of the MAHA initiative, the FDA released a draft guidance document titled “Replacing Color Additives in Approved or Marketed Drug Products.”

June 2025

June 2 – The FDA launched their agency-wide AI tool, Elsa. As described by the agency, Elsa is “a generative Artificial Intelligence (AI) tool designed to help employees—from scientific reviewers to investigators—work more efficiently. This innovative tool modernizes agency functions and leverages AI capabilities to better serve the American people.”

June 2 – Julie Tierney, JD, long-time FDA employee and CBER deputy director of Strategy, Policy and Legislation, resigned.

June 5 – Commissioner Makary posted on X about the first stop on the CEO listening tour, “The pathway to improving patient access to safe and effective therapies starts with listening. Today FDA kicked off its Pharma and Biotech CEO Listening Tour in White Oak, MD. More than 60 CEOs shared their personal insights and big ideas.”

June 9 – RFK Jr fired all 17 members of the Advisory Committee for Immunization Practices (ACIP). ACIP is a panel that provides recommendations to the Centers for Disease Control and Prevention (CDC) regarding the safety, effectiveness, and clinical necessity of vaccines.

June 10 – Commissioner Makary and CBER director Prasad published a paper in JAMA outlining their priorities for the new FDA. Their priorities included using AI to accelerate drug approvals, improving food safety for children by removing chemically manipulated foods, harnessing big data to determine the root causes of chronic diseases and for post- approval surveillance of new drugs. They also emphasized the need to rebuild public trust in the FDA after the illegal approval of OxyContin.

June 11 – RFK Jr “repopulated” the ACIP with eight new members. Joseph Hibbeln, MD, Martin Kulldorff, PhD, Retsef Levi, PhD, Robert Malone, MD, Cody Meissner, MD, James Pagano, MD, Vicky Pebsworth, PhD, RN, and MichaelRoss. MD, were appointed to the panel and described by RFK Jr in his X post as “committed to evidence-based medicine, gold-standard science, and common sense.”

June 17 – The FDA announced the Commissioner’s National Priority Voucher program that aims to shorten the current review time of 10-12 months to 1-2 months by utilizing a multidisciplinary “tumor board style” review. A limited number of vouchers will be awarded to companies that align with U.S. national priorities.

June 18 – Vinay Prasad, CBER director was given an additional position as the agency’s chief medical and scientific officer. Until now, the positions of chief medical officer and chief scientist at the FDA have been held separately.

June 18 – Nicole Verdun, MD, and Rachael Anatol, PhD, who served as the director and deputy director of CBER’s Office of Therapeutic Products, were placed on administrative leave.

June 18 – The FDA announced an immediate suspension and review of all new clinical trials that propose sending the living cells of American citizens to laboratories in China and other countries deemed hostile.

June 23 – Acting CDER director Jacqueline Corrigan-Curay, MD, JD, announced her plan to retire in July.

June 23 – Tala Fakhouri, PhD, MPH, who served as the associate director for data science and AI policy at CDER, departed from the agency.

June 24 – Mike Davis, MD, PhD, rejoined the FDA as the deputy director of CDER.

July 2025

July 14 – The FDA has formally ended the employment of thousands of individuals who, on April 1, 2025, were notified of their inclusion in the reduction in force. It is still not publicly known how many were hired back in the interim.

July 20 – Laura Loomer, a conservative political advisor close to President Trump, wrote a blog post titled “Meet Vinay Prasad: The Progressive Leftist Saboteur Undermining President Trump’s FDA.” Keep this in mind as you read the July 30 update.

July 21 – George Tidmarsh, MD, PhD, a highly experienced executive in the biotechnology sector, was appointed as the director of CDER.

July 22 – Sonja Fulmer, PhD, who had been serving as acting director of the FDA’s Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH), retired.

July 30 – Vinay Prasad, director of CBER and the agency’s chief medical and scientific officer, leaves the FDA.

July 31 – Ten days after George Tidmarsh joined the agency as director of CDER, he was named the acting director of CBER. He will be managing both roles until a permanent replacement for Vinay Prasad can be found. The replacement for Prasad’s other role at the agency, as the chief medical and scientific officer, has yet to be announced.

July 31 - The FDA ordered updates to the safety labeling on all opioid pain medications to more clearly highlight and thoroughly explain the risks associated with long-term use.

July 31 – President Trump sent letters to 17 major pharmaceutical companies criticizing their attempts at reducing prices. He granted them an additional 60 days to comply with his Most-Favored-Nation drug-pricing policy.

Conclusion

As this timeline makes clear, the FDA is in the midst of rapid change—shaped by political directives, leadership shifts, and bold new initiatives. While the pace of announcements suggests a return to business as usual, the substance of these developments points to a “new normal” that will continue to test the agency’s adaptability and the industry’s ability to respond. For those of us tracking regulatory intelligence, the coming months will require close attention, thoughtful analysis, and a readiness to adjust. Nonetheless, one thing is certain: the FDA of today is not the FDA of yesterday.