Venable FDA Pulse

FDA Announces "CEO Forums" Initiative and Enhancements to State Importation Program

Through our Venable FDA Pulse series, we report on critical developments within the Food and Drug Administration (FDA or Agency) that may affect the Agency's structure and stakeholder interactions. This week's updates are as follows:

FDA announces "CEO Forums" listening tour
FDA's plan to improve state importation programs

FDA's "CEO Forums" Listening Tour

FDA announced a six-city listening tour, called "CEO Forums," in which FDA leadership will meet with chief executive officers (CEOs) of pharmaceutical and biotech companies to gather their thoughts on how "FDA can modernize its regulatory framework to better support innovation and patient access to safe and effective therapies." FDA Commissioner Marty Makary, M.D., M.P.H., will lead the forums as will Principal Deputy Commissioner Sara Brenner, M.D., M.P.H., and Director of the Center for Biologics Evaluation and Research Vinay Prasad, M.D., M.P.H. To register for the forum, participants must have on file with the Agency at least one active (1) Investigational New Drug (IND) Application, (2) New Drug Application (NDA), or (3) Biologics License Application (BLA). Additional information, such as dates and cities, were provided in the announcement. The first forum will be held on June 5, 2025, from 3 to 5 p.m. at FDA's Silver Spring, Maryland location.

FDA's Plan to Improve State Importation Programs

Pursuant to President Trump's Lowering Drug Prices by Once Again Putting Americans First executive order, FDA announced "enhancements" to the Federal Food, Drug and Cosmetic Act's Section 804 importation program. The program permits "states and Indian tribes to import certain prescription drugs from Canada to significantly reduce the cost of these drugs to the American consumer, without imposing additional risk to public health and safety." As part of these enhancements, FDA will allow states and tribes to submit draft Section 804 importation program (SIP) proposals for pre-review and will provide opportunities for informal meetings to obtain initial feedback on the proposals before formal submission. FDA will also take the following steps to support state importation programs:

Develop a user-friendly tool to help states create SIP proposals
Provide states with options to streamline the proposal's cost savings analysis requirement and offer input on the information states may use in estimating cost savings

Furthermore, FDA expects to meet with interested states in the fall to discuss these actions and obtain feedback. The Agency describes the meeting as "a forum to exchange information that will make it easier for states to obtain authorization while protecting public safety."

Venable will continue to monitor all changes regarding FDA and report any critical developments. If you have questions on how the contents of this article may impact your or your business's interactions with FDA, please contact the authors today.

FDA Announces New Leadership While Dr. Makary Addresses Staffing Cuts at Senate Hearing

FDA welcomes new Tobacco and Inspections leadership
Commissioner Makary speaks on FDA budget and staffing cuts during appearance on Capitol Hill

FDA Announces New Leadership in Tobacco Center and Inspections Office

Last week, FDA announced Dr. Elizabeth Miller will be acting associate commissioner for inspections and investigations, replacing Michael Rogers, who retired from the Agency in early May. According to Dr. Miller's leadership profile, she recently served as the deputy associate commissioner for medical products and previously held the position of assistant commissioner for medical products and tobacco operations. At the same time, the Agency welcomed Dr. Bret Koplow as acting director of the Center for Tobacco Products (CTP). Dr. Koplow's leadership profile states that he previously served as senior counselor to the commissioner in the Immediate Office of the Commissioner, where his work included policy, regulatory, and operational matters involving CTP, such as e-cigarettes and tobacco products. Dr. Koplow replaces Dr. Brian King, who was fired during the April staffing cuts within FDA.

Commissioner Makary Speaks on Staffing Cuts During Senate Budget Hearing

Several news outlets reported on FDA Commissioner Makary's May 22 appearance before a Senate Appropriations Subcommittee regarding FDA's $6.8 billion budget request for the 2026 fiscal year. Of the $6.8 billion budget, $3.2 billion will be in budget authority and the remaining $3.6 billion in user fees—an overall 5.5% reduction and an 11.5% reduction in budget authority compared with this fiscal year's budget.

Notably, during the hearing, Dr. Makary was questioned about the impact of the April staffing cuts on the Agency's ability to efficiently operate, particularly in approving rare disease drug applications. Dr. Makary said that staffing cuts had not impacted approval schedules, but delays in reviews may occur because of the complexity of the drugs, and the Agency is on pace to meet all PDUFA deadlines. However, Dr. Makary admitted that the Agency has rehired some employees who were terminated during the staffing cuts. The ranking member of the subcommittee stated that information on where the staffing cuts occurred within FDA centers and offices was needed as they write the Agency's budget.

Venable will continue to monitor all changes regarding FDA and report any critical developments. If you have questions on how the contents of this article may impact you or your business's interactions with FDA, please contact the authors today.

Commissioner Makary talks FDA Priorities, HHS Deregulation, and HHS Layoffs Face Legal Pushback

Commissioner Makary gives fireside chat at the 2025 Food and Drug Law Institute (FDLI) Annual Conference
The U.S. Department of Health and Human Services (HHS) Deregulatory Initiative
A federal lawsuit brought by 20 attorneys general against HHS

Dr. Martin Makary's Fireside Chat at FDLI Annual Conference

Dr. Martin Makary, renowned public health expert, advisor, and newly appointed FDA commissioner, delivered a highly anticipated Fireside Chat today at the FDLI Annual Conference in Washington, DC. His remarks addressed the FDA's priorities following the recent reduction in force, including a commitment to the gold standard science, and restoring agency morale. Makary reiterated there are no plans for major reorganization, affirming the FDA's product-by-product review structure. He emphasized the need for strong but independent partnerships with industry, highlighted the unique challenges of rare disease approvals, and underscored efforts to reduce burdens and streamline the approval process.

HHS Opens 60-Day Public Comment Period on Deregulatory Initiative

HHS and FDA have initiated a 60-day public comment period to gather feedback on their proposed deregulation plan. This initiative, aligned with the "10-1" directive, is intended to eliminate at least 10 existing regulations for every new one introduced. Stakeholders are encouraged to submit their suggestions for regulations, guidance documents, or policies that may be outdated, burdensome, or unnecessary. Comments can be submitted through the official portal at regulations/gov/deregulation until July 14, 2025.

HHS Restructuring and Layoffs Face Legal Challenge

On May 5, 2025, attorneys general, representing 19 states and the District of Columbia, filed a lawsuit in Rhode Island federal court, alleging that HHS's restructuring effort and staffing cuts have hindered HHS and its agencies' ability to perform their statutory functions. Regarding FDA, the complaint argues that the layoffs will prevent the Agency from "promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner." The complaint discusses the effects of certain terminations, including how FDA suspended a planned bird flu detection exercise because employees working in an Illinois food safety lab were fired. The attorneys general claim their states "are already suffering consequences of these terminations and reorganizations" and seek declaratory and injunctive relief to stop HHS's restructuring and workforce reduction.

No Reorganization Ahead, but Uncertainty Remains Around Staffing and CDER's Ombudsman

The latest FDA leadership changes
FDA Commissioner Makary confirms that FDA will not undergo reorganization
Rehiring efforts following staff terminations and
Uncertainty around the Center for Drug Evaluation and Research (CDER) Office of the Ombudsman

Recent FDA Leadership Changes

On May 6, 2025, Commissioner Makary announced via the social media platform X that Dr. Vinay Prasad will be the next director of the Center for Biologics Evaluation and Research, succeeding Dr. Peter Marks, who resigned from FDA in April. Additionally, Politico reported that Jeremy Walsh will serve as the Agency's inaugural chief artificial intelligence (AI) officer. While FDA welcomed these new leaders, it was reported that Michael Rogers, the associate commissioner for inspections and investigations, will retire from the Agency. Rogers' departure comes as FDA plans to increase unannounced inspections at foreign manufacturing facilities that make food, essential medicines, and other medical products for U.S. consumers and patients.

Update: Commissioner Makary Confirms That FDA Will Not Be Reorganized

As we previously discussed in our 100-day review of the second Trump administration, it was reported that HHS had considered a plan to reorganize FDA into five or six offices by combining similar activities of the centers, such as product reviews, policy, and inspections, into single offices. However, on April 29, 2025, Commissioner Marty Makary stated in an interview with MedPage Today that FDA will not be reorganized. Instead, FDA plans to consolidate information technology and travel offices, as well as "other things that make sense for efficiency." Dr. Makary mentioned that a reorganization plan for FDA had been proposed, but that he rejected it.

Rehiring of Some FDA Staff

Dr. Makary's confirmation provides relief to those concerned about how the plan might have affected FDA's ability to review regulated products, especially considering that the Agency recently lost a significant number of staff because of workforce reduction. Relatedly, it was reported that FDA will rehire some employees who were fired during the April workforce reduction or has asked them to return, including food safety scientists, those who make travel arrangements for safety inspectors, employees who handled Freedom of Information Act requests, and user fee negotiation personnel.

CDER Ombudsman in Limbo: What This Means for Drug Application Reviews

CDER's Office of the Ombudsman, which investigates complaints and resolves disputes between CDER and stakeholders, may be closed. However, it is unclear whether this closure will be permanent or temporary. On April 18, 2025, Bloomberg Law reported receiving an automated email from the office stating that its "services are currently unavailable" and recommending that the recipient contact the office again in May, when it anticipates having additional information. According to the report, a source confirmed that staff in the Office of the Ombudsman were included in the staffing cuts at FDA. Additionally, the news outlet received another automated email stating that Virginia Behr, the CDER ombudsman, retired on April 10, 2025.

At this time, there has been no update on the status of the CDER Ombudsman's office or whether operations have resumed since the news was first reported. The potential closure of the Ombudsman's office would be impactful, as the office served as a key resource for efficiently, quickly, and informally resolving regulatory, scientific, and administrative disputes that may arise during the drug review process.

FDA at the 100-Day Mark of Trump Administration 2.0

Since returning to office for a second term, President Trump has taken steps to reshape federal agencies. Here, we discuss the significant changes that have occurred at the Food and Drug Administration (FDA or Agency) during the first 100 days of the second Trump administration, including (1) the appointment of a new commissioner; (2) changes in FDA leadership; and (3) plans to reorganize the Agency and reduce its workforce.

New FDA Commissioner

On March 25, 2025, Martin "Marty" Makary was confirmed by the Senate to be the 27th Commissioner of Food and Drugs (FDA commissioner). Former Acting Commissioner Sara Brenner will serve as principal deputy commissioner.

In remarks given during a welcome ceremony at FDA headquarters, Makary stated his goal is "to ensure that the FDA holds to the gold standard of trusted science, transparency, and common sense to rebuild public trust and advance health and safety in the United States and worldwide." Makary mentioned an array of different topics, including the "chronic disease epidemic," obesity, and autism, without announcing specific policy prescriptions. Makary discussed the need for people "with a range of perspectives and critical thinkers to respond following the scientific method and using common sense." Commissioner Makary will speak at the 2025 Food and Drug Law Institute (FDLI) Annual Conference on May 15, as well as Robert Foster, the U.S. Department of Health and Human Services (HHS) deputy general counsel and chief counsel for food, research, and drugs. The position of chief counsel for food, research, and drugs was created as part of the reorganization of HHS's office of the general counsel and supervises FDA's chief counsel.

As Makary's tenure progresses, we will be monitoring how he brings his vision for FDA into action.

FDA Leadership Changes

As Commissioner Makary began his tenure, FDA experienced layoffs, resignations, and retirements, all of which are ushering in a new regulatory environment for drugs, devices, and other regulated products. Below is the current state of FDA leadership as of April 28, 2025:

Center for Devices and Radiological Health (CDRH)
- Michelle E. Tarver, Director
Center for Drug Evaluation and Research (CDER)
- Jacqueline Corrigan-Curay, Acting Director
Center for Biologics Evaluation and Research (CBER)
- Scott Steele, Acting Director (replaced Peter Marks, who resigned earlier this month)
Center for Tobacco Products (CTP)
- Vacant, Director (previously held by Brian King, who was placed on administrative leave earlier this month)
Human Foods Program
- Kyle Diamantas, Acting Deputy Commissioner for Human Foods (replaced James "Jim" Jones, who resigned in February 2025)

Additionally, it was reported that Makary made the following appointments last week as part of his efforts to finalize his team:

Center for Veterinary Medicine (CVM)
- Timothy Schell, Acting Director
Craig Taylor, Acting Chief Information Officer (replaced Vid Desai, who was placed on administrative leave earlier this month)
Lowell Zeta, Deputy Commissioner for Strategic Initiatives

Additional leadership positions remain vacant as of April 28, 2025, including chief counsel and chief medical officer.

Implications of Staffing Cuts, Proposed Agency Restructuring, and Budget Changes

In April, HHS began implementing plans to reduce its workforce, which, according to a fact sheet, will result in FDA losing "approximately 3,500 full-time employees." The fact sheet states that the cuts "focus on streamlining operations and centralizing administrative functions" and "will not affect drug, medical device, or food reviewers, nor will [they] impact inspectors." These cuts follow an earlier round of terminations that occurred in February. Notably, there have been reports that FDA has rehired or reinstated some fired personnel, suggesting that cuts may have been made to positions that the Agency later determined were necessary.

Return-to-office orders could further reduce FDA's workforce along with the planned staffing cuts. Employees living outside a 50-mile radius of FDA's headquarters are to report in person starting April 28, potentially leading to attrition. Moreover, according to reports, HHS has considered a plan to restructure FDA into five or six offices, by merging similar activities of the centers, such as product reviews, policy, and inspections, into single offices. Additionally, news outlets have reported on a leaked HHS budget document that proposes significantly reducing FDA's overall funding but allocates adequate funding to maintain the user fee programs.

Although Makary has struck a positive tone so far, the combination of staffing cuts, a smaller budget, and a reorganization of the Agency could impact FDA's ability to review regulated products. Several PDUFA decision dates are pending in the next few weeks that may provide insight into FDA's current ability to meet target deadlines. Additionally, there are reports that FDA is planning to end most of its routine food inspections work, which would be outsourced to state and local authorities. Meanwhile, FDA recently announced its plan to phase out petroleum-based synthetic dyes from the U.S. food supply. Further, the Agency is continuing to work to educate stakeholders about the updated "healthy" nutrient content claim rule, which went into effect April 28, by publishing a pre-recorded webinar that outlines the rule.