HHS and FDA Prepare for Significant Budget Cuts
The Trump Administration is preparing “agency-wide” cuts across the Department of Health and Human Services (HHS), according to inside sources familiar with the plans. Despite yesterday’s deadline for submission to the White House, HHS has not publicly released its reduction in force plans. These cuts are expected to significantly impact FDA operations in the coming months.
Meanwhile, Congress has passed a stopgap spending bill to avert a government shutdown. The Senate approved the measure in a 62-38 vote, following the House’s earlier passage. This legislation will maintain FDA’s funding at the FY 2024 appropriated level for the next six months, providing temporary stability during this transition period.
Leadership Changes and Office Reorganization
FDA has appointed Jim Traficant as its new chief of staff. In this critical role, Traficant will oversee the agency’s daily operations, lead major initiatives, and serve as a direct liaison between the commissioner and other executive agencies. His responsibilities will include legislative engagement, communications, and stakeholder outreach.
As part of Secretary Kennedy’s “Make America Health Again” initiative, HHS has announced a significant reorganization of its Office of General Counsel (OGC). This restructuring will consolidate regional offices from ten to just four, maintaining locations in Philadelphia, Atlanta, Kansas City (MO), and Denver only.
In other leadership news, Douglas Kelly, a senior leader with FDA’s medical device center who served as deputy center director for science at CDRH, has announced his resignation from the agency.
Return-to-Office Challenges for FDA Staff
Thousands of FDA employees are returning to in-person work starting Monday at the White Oak, MD campus, raising serious logistical concerns. Reports indicate that while over 10,000 employees report to this location, there are only 6,000 on-campus parking spots available. Reuters has reported a scramble for workspaces and parking ahead of this mandated return.
Advisory Committee Controversy and Vaccine Policy Shifts
Former FDA Commissioner Peter Pitts argues against conflict of interest-free policies for FDA advisory committees, stating that private-sector experience is essential for public health. He maintains that the public would not benefit if FDA were unable to recruit experts with industry knowledge.
An NPR report has disputed Health Secretary Robert F. Kennedy Jr.’s claims that most vaccine advisors have conflicts of interest. The OIG report covering all 17 CDC advisory committees did not find serious conflicts among most members, though it identified some issues with disclosure paperwork.
In related news, the Trump Administration has withdrawn Dave Weldon’s nomination to run the CDC hours before his scheduled hearing, reportedly concerned that his history of vaccine criticism would jeopardize his confirmation chances.
Regulatory Changes and State-Level Actions
Secretary Kennedy is directing FDA to explore potential rulemaking to revise its Substances Generally Recognized as Safe (GRAS) final rule, potentially eliminating the self-affirmed GRAS pathway. This would significantly enhance FDA’s oversight of ingredients currently considered GRAS.
Meanwhile, several states including Florida, Idaho, Kentucky, South Carolina, and Texas are considering legislation to limit or ban the use of mRNA vaccines. These measures range from complete bans to prohibitions on pediatric use to mandatory disclosures about long-term safety.
Pharmaceutical and Medical Device Updates
A federal judge has denied a motion that would have allowed members of the Outsourcing Facilities Association to continue compounding tirzepatide, a GLP-1 medication, after determining that the shortage of this drug has been resolved.
Congresswoman Doris Matsui (D-CA) and three co-sponsors have reintroduced the Scientific External Process for Educated Review of Therapeutics (EXPERT) Act of 2025, which would formalize the Externally-Led Scientific-Focused Drug Development meeting process at FDA. The legislation would require quarterly meetings with different rare disease expert groups.
In the medical device sector, Johnson & Johnson has received 510(k) clearance for its AI-powered software for the Monarch robotic lung biopsy platform. The software aims to improve nodule reading accuracy through enhanced computational power using Nvidia technology.
Reports indicate that approximately 10% of postmarket device safety reports were submitted over six months after safety events occurred, with some manufacturers ignoring FDA deadlines for reporting to the MAUDE database.
Research Funding Concerns
Researchers at National Cancer Institute-designated cancer centers are expressing concern about future funding. Some centers have had grant renewal site visits cancelled or rescheduled as virtual meetings, while others await funding despite grant approvals. Advisory councils responsible for final funding decisions have been cancelled without rescheduling.
The National Organization for Rare Disorders (NORD) has announced a meeting on June 2-3 in Washington, DC, focusing on real-world research breakthroughs, novel trial designs, and collaborative efforts by NORD Rare Disease Centers of Excellence.
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