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:
- Commissioner Makary and CBER Director Discuss "Priorities for a New FDA"
- HHS Reconstitutes the Advisory Committee for Immunization Practices
- FDA's FY 2026 Budget Proposal Updates
- Lowell Zeta Appointed as Special Counsel for FDA
Commissioner Makary and CBER Director Discuss "Priorities for a New FDA"
On June 10, FDA Commissioner Marty Makary, M.D., M.P.H., and Center for Biologics Evaluation and Research (CBER) Director Vinay Prasad, M.D., M.P.H., published an article in JAMA in which they outline their "priorities for a new FDA." The article discusses various topics, including artificial intelligence, use of health data and cloud computing, and "accelerating cures." In the article, Dr. Makary and Dr. Prasad state that FDA "aim[s] to pilot programs to deliver sponsors a decision in weeks." Under the pathway, sponsors would submit certain paperwork to FDA "in advance of their final application, enabling regulators to examine the manufacturing plans, draft labels, and packaging before a clinical trial is complete."
Notably, Dr. Makary has made previous statements in which he discusses a "new pathway for drugs" for rare conditions or diseases, in which FDA grants approval "on a conditional basis," "based on a plausible mechanism," and that includes monitoring of individuals who receive the drugs. Furthermore, conditional approval could be granted despite the absence of a randomized controlled trial under the Commissioner's proposal. With regard to rare disease products, the JAMA article mentions that "postapproval monitoring in Big Data will allow the FDA and researchers to see safety signals in real time and evaluate effectiveness in the real world" and how this is significant for such products because "premarket randomized trials may not be feasible." U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. has also expressed support for fast-tracking the approval process for rare disease products and treatments. We will monitor congressional action on these proposals and monitor HHS and FDA's regulatory activity—including public comment and Guidance issuances—that could provide additional clarity.
HHS Reconstitutes Advisory Committee for Immunization Practices (ACIP)
According to a June 9 press release, HHS has removed the sitting 17 members of the ACIP and plans to replace them with new members. ACIP is tasked with making "recommendations on the safety, efficacy, and clinical need of vaccines to the Centers for Disease Control and Prevention (CDC)." On June 11, HHS Secretary Robert F. Kennedy Jr. announced, via the social media platform X, eight new members who he says will attend the next ACIP meeting, which is currently scheduled for June 25-27 at the CDC's Atlanta headquarters. The June 25-27 meeting agenda includes several timely issues, such as COVID and seasonal flu vaccines.
FDA's FY 2026 Budget
On May 30, 2025, FDA released its fiscal year (FY) 2026 budget documentation, which was accompanied by a summary fact sheet. According to the fact sheet, the FY 2026 budget includes:
- $6.8 billion in overall funding, with $3.2 billion in budget authority, which is $408.8 million less than the amount enacted for FY 2025
- $3.6 billion in user fees, which exceeds the FY 2025 amount by $137.3 million
- A $118.2 million increase "to ensure that the Devices Program can continue collecting and spending user fee funding needed to review new medical devices."
Furthermore, "the [b]udget request […] includes a decrease of -1,940 FTEs and -$456.6 million in budget authority to support the reduction of federal bureaucracy initiative."
Relatedly, the House Appropriations Committee unveiled the text of its FDA budget, which provides the Agency with $6.69 billion in funding, which is the level proposed in the presidents' FY26 budget. The bill was approved by the House Appropriations Subcommittee on June 5.
Lowell Zeta Appointed as Special Counsel for FDA
The Agency's current Deputy Commissioner for Strategic Initiatives Lowell Zeta has also been named the special counsel for FDA in the Office of the Chief Counsel. According to his leadership profile, Zeta's duties as special counsel for FDA include providing "legal counsel and strategic counsel on high-priority regulatory and administrative actions and cross-cutting legal issues involving emerging technologies such as artificial intelligence, domestic manufacturing and foreign inspections, and risk management for regulations, guidance, and policy development[.]"
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.