Tracking Major Changes at the FDA: April 10
Agency reorganization effects, tariffs for pharma, and biotech CEOs reporting FDA disruptions.
With the flurry of FDA updates, we’ll be sharing brief, semi-regular news roundups — quick, digestible explainers to keep you on top of the latest developments. Make sure you’re on our paid tier to get each issue in full.
Here’s a brief synthesis of the most recent reporting.
FDA reorganization and leadership changes
New FDA commissioner described as an "instant pariah" — POLITICO reports that FDA Commissioner Marty Makary, who approved the firing of Peter Marks and other senior regulators in his first days, has become "an instant pariah among many of his own employees." Current and former FDA employees indicated that many offices are "effectively nonfunctional" as supervisors focus on determining who was cut and which programs are affected, despite Kennedy's claims that the firings only targeted redundancies.
FDA eliminates training division — CNBC reports that the FDA has gutted its Division of Learning and Organizational Development (DLOD), laying off all 30+ employees. This division trained agency staff and external healthcare professionals on key practices including opioid safety, avoiding medication errors, infectious disease management, and clinical trials. The division also supported:
Professional development for FDA employees
Processing and approval of continuing education activities across the FDA
Monthly presentations highlighting agency research and its public health impact
Awarding credits to healthcare professionals for completing educational activities
One office within DLOD was fully funded by industry user fees rather than taxpayer dollars, raising questions about the administration's cost-saving justification. The Continuing Education and Consultation Accreditation Team was the only group within the FDA authorized to issue continuing education credits to both FDA employees and outside healthcare professionals.
HHS to brief Energy and Commerce Committee — POLITICO is also reporting that HHS staff (not Secretary Kennedy himself) will brief the Energy and Commerce Committee's staff this Friday regarding recent layoffs at HHS and FDA and the pending reorganization.
Analysis of impact on generic drug policy — Hyman, Phelps and McNamara's Kurt Karst published an enlightening analysis of how the reduction-in-force layoffs have affected the FDA's Office of Generic Drugs Policy. This office is responsible for creating product-specific guidance, fulfilling Generic Drug User Fee Act commitments, processing generic drug withdrawals, and writing and updating guidance documents.
Pharmaceutical tariffs
Trump announces pharmaceutical tariffs — President Trump has announced plans for "a major tariff on pharmaceuticals," sending the industry scrambling to understand potential implications. According to Mollie Sitkowski, a trade compliance partner at Faegre Drinker, implementation may follow patterns seen with automotive and steel tariffs, which involved 25% levies following investigations.