Shutdown Updates, FDA Orphan Drug Leader Reassigned as CMS Issues Orphan Drugs Guidance, FDA to Host Allergen Threshold Meeting, and Commissioner’s National Priority Review Vouchers

Through our Venable FDA Pulse series, we provide insight into key developments within the Food and Drug Administration (FDA or the Agency), emerging trends, enforcement activity, and other topics impacting stakeholders. This week’s updates:

1. Congress Weighs “Minibus” That Includes FDA Funding as the Agency Is Spared from Latest Layoffs
2. Leadership Change at Office of Orphan Product Development
3. CMS Issues Drug Negotiation Program Guidance Excluding Orphan Drugs
4. FDA to Host Virtual Public Meeting and Listening Session on Food Allergen Thresholds
5. FDA Grants First Commissioner’s National Priority Review Vouchers

Congress Weighs “Minibus” That Includes FDA Funding as the Agency Is Spared from Latest Layoffs

Last week, Politico reported on lawmakers’ efforts to fund FDA and other agencies during the shutdown via a “minibus” package, and to start negotiations to resolve differences in the House and Senate versions of the minibus bills. In related news, it was reported that FDA staff will not be included in any reductions in force that were affecting other HHS divisions, following discussions between FDA Commissioner Dr. Marty Makary, M.D., M.P.H., and White House budget officials. FDA has already faced high turnover this year because of staffing cuts and departures.

Leadership Change at Office of Orphan Product Development

According to EndPoints News, this month Sandra Retzky was removed from her role as director of the FDA’s Office of Orphan Products Development and reassigned within the Agency. The leadership shift occurs at a critical moment, as FDA proposes changes to its rare-disease policy. As we previously discussed, FDA (CDER and CBER) unveiled its Rare Disease Evidence Principles (RDEP) to speed up the review and conditional approval of therapies to treat rare diseases.

CMS Issues Drug Negotiation Program Guidance Excluding Orphan Drugs

Last month, the Centers for Medicare and Medicaid Services (CMS) issued final guidance governing negotiations under the Medicare Drug Price Negotiation Program. The guidance notes that the agency is implementing the amendments to the Orphan Drug Exclusion that were contained in the One Big Beautiful Bill Act signed into law on July 4^th, 2025. The amendments allow drugs approved for multiple rare diseases to be excluded from negotiations, provided that the approved uses are only for rare conditions. Such drugs only become eligible for negotiation when a product secures a non-orphan/non-rare indication.

FDA to Host Virtual Public Meeting and Listening Session on Food Allergen Thresholds

For three days in November, FDA will hold a virtual public meeting (November 18) and listening sessions (November 19–20) to help guide next steps, evaluate options, and advance the Agency’s food allergen threshold approaches.

FDA notes that recent developments regarding allergen risk assessment suggest that low-level exposures (thresholds) may not trigger reactions in most allergic individuals. These thresholds could inform FDA’s approach to labeling exemptions, compliance/enforcement actions, allergen advisory statements (AAS) policy, and allergen cross-contact guidance. Currently, FDA has not established or endorsed specific allergen threshold levels.

While the November event will focus on major food allergens (e.g., milk, eggs, fish, shellfish, tree nuts, wheat, peanuts, soybeans, and sesame), the outcomes may also inform broader strategies regarding other food allergies and intolerances. Interested parties should visit here to register and review resources in preparation for the first day of presentations and panels on November 18.

FDA Grants First Commissioner’s National Priority Review Vouchers

Last week, the FDA awarded nine “Commissioner’s National Priority Review Vouchers” to sponsors developing products that address major U.S. health priorities, such as infertility, Type 1 diabetes, nicotine addiction, and deafness. The pilot program, announced in June 2024 and initially expected to issue no more than five vouchers, aims to accelerate approval timelines for therapies that meet national needs or strengthen domestic manufacturing. Each voucher allows its holder to shorten a future drug or biologic review to as little as two months, offering a major competitive advance. The awards underscore the FDA’s commitment to incentivizing innovation tied to public-health impact and supply-chain resilience.