radical transparency

FDA layoffs imperiling Makary’s bid to end conflicts of interest

Jacquelyn Martin/AP

Before he took over the FDA, Marty Makary publicly stumped for frequent, transparent meetings of independent panels that advise the agency on controversial regulatory decisions. But his bid for “radical transparency” may be in jeopardy after recent cuts at the FDA have imperiled panel members’ ability to plan and run those meetings — and root out worrisome conflict of interests in potential committee members.

The trouble started in April, when HHS fired 3,500 workers at the FDA. Many members of the advisory committee staff, including the drug center’s conflict of interest team, have not been brought back. Meetings are being postponed and lawyers in the commissioner’s office are now handling conflict of interest screenings. One agency ethics official said, “He’s making these broad public statements but nothing has changed internally except for the lack of staff that would handle those issues.”

Anxiety inside the agency has only grown since health secretary Robert F. Kennedy Jr. silently changed the locks at the CDC — replacing its vaccine panel with handpicked allies, some of whom have testified in lawsuits challenging vaccines. Read more from STAT’s Lizzy Lawrence, who artfully illustrates an agency in turmoil and explains why FDA may now be operating with fewer safeguards, not more. — Neha Gopal

EXCLUSIVE

Duchenne therapy drama at FDA

Nicole Verdun, the FDA’s chief regulator of cell and gene therapies, was placed on administrative leave immediately after a disagreement with her new boss over the review of a cell therapy for Duchenne muscular dystrophy. The move could signal a shift inside the FDA over the standards of evidence that should be required for the approval of cell and gene therapies, but long-simmering tensions over Verdun’s management style may have also contributed to the decision, STAT has learned.

Verdun had scheduled an advisory committee meeting to review the therapy developed by Capricor Therapeutics. Vinay Prasad, the new director of the Center for Biologics Evaluation and Research, was skeptical of the treatment and decided unilaterally to cancel the meeting and place her on administrative leave.

Forcing out a well-respected figure with deep expertise on cell and gene therapies has caused angst for the biopharma industry and the patient advocate community. It also continues the volatility that CBER employees have faced since the start of the Trump administration. Four of my colleagues are on the byline here, so you know it’s a good one. Read on.

POLICY

Hospitals aim to shape Senate Medicaid debate

Medicaid drama kicks back up this week. As the Senate debates Medicaid policies that could cost hospitals billions of dollars and lead to millions losing coverage, hospitals are scrambling to control the damage, write STAT’s Daniel Payne and John Wilkerson.

The Senate Finance Committee unveiled its version of the One Big Beautiful Bill, which included steeper Medicaid cuts than the House’s version. Hospitals are now lobbying senators to return to the House’s version, which also is expected to substantially cut hospitals’ revenues and the number of patients covered — but less so than the Senate’s version of the bill. 

Rural hospitals are believed to be at highest risk of closure from the cuts, which has some Senate Republicans displeased with their chamber’s version and willing to propose additional funding. Read more from my D.C. colleagues.