This Week at FDA: More HHS, FDA cuts expected soon; Congress passes stopgap spending bill

Welcome to another installment of This Week at FDA, your weekly source for updates—big and small—on FDA, drug, and medical device regulation and what we’re reading from around the web. This week, news broke that additional cut across the Department of Health and Human Services (HHS) are expected shortly, and the House and Senate have passed a stopgap spending bill to fund the government for the next six months.

On Friday, the Senate passed a stopgap spending bill in a 62-38 vote to avert an impending government shutdown just days after the House passed the bill, CBS News reports. The bill would maintain FDA’s funding at FY 2024 appropriated level.

In other news, Politico reports that the Trump Administration is preparing for “agency wide” cuts across HHS, according to people familiar with the plans. HHS has not publicly released its plans for a reduction in force, even though those plans were due to the White House yesterday.

FDA has appointed Jim Traficant as its new chief of staff. In this role, he will oversee the agency’s daily operations and lead major initiatives. He will also act as a direct liaison between the commissioner to other executive agencies and organizations. Additionally, Traficant will focus on legislative engagement, communications, and outreach to stakeholders.

Thousands of FDA employees are expected to return to the office in person starting Monday, and there are concerns about possible traffic implications when they return to the White Oak, MD campus, according to a report from WTOP. FDA has over 10,000 employees that report to the White Oak campus but only 6,000 on-campus parking spots, said a federal worker who sent an email to WTOP. Reuters also reports of a scramble for workspaces and parking spots ahead of Monday’s return to office.

Former FDA Commissioner Peter Pitts argues in an opinion piece in STAT News that a conflict of interest-free policy for FDA advisory committee is a “terrible idea.” He emphasizes that private-sector experience is essential for public health, and that the public would not benefit if FDA were unable to recruit these experts.

HHS just announced a reorganization of the Office of General Counsel (OGC), as part of the department’s efforts to advance Secretary Kennedy’s Make America Health Again initiative. The move will consolidate the number of regional offices from 10 to four. Regional offices will be maintained in Philadelphia, Atlanta, Kansas City (MO), and Denver.

An NPR report disputes Health Secretary Robert F. Kennedy Jr.’s claims that most vaccine advisors have conflicts of interest. An OIG report covering all 17 CDC advisory committees, did not find serious conflicts among most members. It identified issues with the disclosure paperwork of committee members, including errors or omissions in financial disclosure forms. These issues included placing information in incorrect sections or failing to complete sections.

STAT News reports that the Trump Administration has withdrawn the nomination of Dave Weldon as its pick to run CDC hours before he was scheduled to appear for a hearing, fearing his track record of criticizing vaccines would jeopardize his chances of winning confirmation.

HHS announced that Secretary Robert Kenndy is directing FDA to explore potential rulemaking to revise its Substances Genuinely Recognized as Safe (GRAS) final rule to eliminate the self-affirmed GRAS pathway. The rulemaking will enhance the FDA’s oversight of ingredients considered to be GRAS.

Drugs & biologics

Politico reported that several states, including Florida, Idaho, Kentucky, South Carolina and Texas, are considering bills to limit or ban the use of messenger RNA vaccines in a counter-measure to pandemic-era mandates. Such measures range from outright mRNA vaccine bans in Texas to a prohibition on their use in children in Kentucky to a requirement that vaccinators in South Carolina tell patients that the long-term safety of one of the shots is unknown.

FDA announced that a federal judge has denied a motion to allow members of the Outsourcing Facilities Association to continue compounding the drug ingredient tirzepatide, a GLP-1 medication, after determining that the shortage of the drug has been resolved.

Congresswoman Doris Matsui (D-CA) and three co-sponsors reintroducedthe Scientific External Process for Educated Review of Therapeutics (EXPERT) Act of 2025, legislation to formalize the Externally-Led Scientific-Focused Drug Development (EL-SFDD) meeting at FDA, according to an announcement from Matsui’s office. The legislation calls for the agency to meet with a different group of rare disease experts four times a year.

MedPage Today reports that researchers at National Cancer Institute-designated cancer centers are worried about future funding, with some centers having their site visits for grant renewals cancelled only to have them rescheduled for virtual meetings. Others are still waiting for funding even after grants have been approved, while advisory councils that make final funding decisions had been cancelled and still have not been rescheduled.

The National Organization for Rare Disorders (NORD) announced a meeting on June 2-3 in Washington, DC. The meeting will discuss real-world research breakthroughs, novel trial designs and methodologies, and collaborative efforts taken by the NORD Rare Disease Centers of Excellence.

Medtech

Politico reported that Douglas Kelly, a senior leader with FDA’s medical device center, will be leaving the agency. His resignation was announced in a LinkedIn post. Kelly served as deputy center director for science at the CDRH. According to his post, Kelly said he helped recruit senior talent, including Troy Tazbaz, former director of the Digital Health Center of Excellence, and Ross Segan, former director of the CDRH’s Office of Product Evaluation and Quality.

MedTech Dive reported that Johnson & Johnson received 510(k) clearance for its AI-powered software for its Monarch robotic lung biopsy platform. The software is intended to improve the accuracy in reading suspension nodules through use of a Nvidia platform to increase the device’s computational power.

MedPage Today reported that some manufacturers are ignoring FDA deadlines for reporting device safety report to the MAUDE database. Nearly 10% of postmarket device safety reports were submitted over six months after the occurrence of the safety event.

This Week at FDA: More HHS, FDA cuts expected soon; Congress passes stopgap spending bill

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