FDA Disruptions and Leadership Changes Raise Industry Concerns Amid Makary Hearing

The pharmaceutical industry is closely watching as President Donald Trump's nominee for FDA Commissioner, Dr. Marty Makary, prepares to face a Senate hearing on Thursday. This comes amid a series of disruptions and leadership changes at the FDA, causing growing anxiety within the sector.

Recent FDA Upheavals and Cancellations

The FDA has experienced significant turbulence in recent weeks, with several high-profile cancellations and postponements. A meeting of the Vaccine and Related Biological Products Advisory Committee, scheduled for March 13 to determine vaccine strains for the upcoming flu season, was unexpectedly canceled without explanation. Similarly, a Centers for Disease Control and Prevention (CDC) vaccines advisors meeting was postponed, as was the FDA and National Institutes of Health (NIH) joint Rare Disease Day event originally set for February 27-28.

These cancellations have occurred alongside a wave of leadership changes at the agency. Dr. Patrizia Cavazzoni, who led the FDA's Center for Drug Evaluation and Research (CDER) for seven years, stepped down in January. This followed the resignation of Dr. Namanjé Bumpus, principal deputy commissioner, just weeks earlier.

Workforce Reductions and Industry Impact

Adding to the industry's concerns, the Trump administration has implemented significant workforce reductions at the FDA, with approximately 1,000 employees laid off. However, the agency has indicated plans to request the return of about 300 staff members.

Analysts at Jefferies have noted that these disruptions could potentially increase risks for vaccine development and more aggressive accelerated filings, particularly in rare disease areas. The high employee turnover rate may also jeopardize other agency activities, potentially posing greater risks to biopharma companies.

Despite these concerns, Jefferies analysts urge a balanced perspective, citing recent meetings where companies such as Gilead and Denali reported that their interactions with the FDA have remained on track, with no notable changes or delays. In some instances, the new CDER leadership has even shown increased support for accelerated filings and rare disease initiatives compared to previous oversight.

Makary's Upcoming Hearing and Industry Expectations

Dr. Makary's Senate hearing is expected to provide more clarity on the current state of affairs at the FDA. While serving as the chief of islet transplant surgery at Johns Hopkins, Makary has been vocal in his criticism of certain Department of Health and Human Services decisions, particularly regarding the deployment of coronavirus booster vaccines.

Jefferies analysts anticipate that Makary's stance on the FDA will be neutral, with no expectation of significant shifts in major directions. However, they emphasize that Makary will need to ensure that the agency's resources do not diminish to the point of impacting approvals.

As the pharmaceutical industry anxiously awaits the outcome of Makary's hearing, stakeholders remain hopeful for stability and continued support for innovation in drug development and approval processes.