Conflict with the White House and Commissioner Makary's Resignation

Shortly after U.S. President Donald Trump approved a plan to dismiss Food and Drug Administration (FDA) Commissioner Dr. Marty Makary, Commissioner Makary officially resigned, concluding his 14-month term. This situation stemmed from ongoing policy conflicts with the White House, particularly disagreements over the approval of flavored e-cigarettes. Commissioner Makary strongly opposed the approval of flavored e-cigarettes, citing concerns for youth health, but ultimately yielded to political pressure from the White House and approved 45 products just before his resignation. This is considered a prime example of how the independence of public health authorities can be compromised by political interests.

Chain of Departures in Bio Leadership and Distortion of Decision-Making

During Commissioner Makary's tenure, the FDA experienced an unprecedented series of departures of high-ranking officials, leading to organizational instability. In December 2025, Dr. Richard Pazdur, a leading authority in oncology who had dedicated 26 years to the FDA, warned of political pressure and retired just one month after being appointed as the head of the Center for Drug Evaluation and Research (CDER). Additionally, Dr. Vinay Prasad, the director of the Center for Biologics Evaluation and Research (CBER), which is responsible for the safety of vaccines and biologics, also resigned amid policy controversies. These successive resignations of key experts have led to a decline in the expertise of regulatory reviews and a breakdown in the decision-making system, posing a significant threat to biopharmaceutical companies.

Sarepta Gene Therapy Controversy and Regulatory Instability

At the heart of this leadership crisis lies the controversy surrounding Elevidys (active ingredient: delandistrogene moxeparvovec), Sarepta Therapeutics' (SRPT) gene therapy for Duchenne Muscular Dystrophy (DMD). Dr. Prasad, the former director of CBER, ordered a clinical hold and suspension of sales, citing safety concerns and a lack of clinical efficacy. However, the FDA leadership reversed this decision within a day and maintained the accelerated approval status. This has set a precedent that the criteria for new drug development may be influenced by political pressure or lobbying rather than scientific data, leading the investment market to seriously question the predictability of regulatory agencies.

Allegations of Vaccine Data Concealment and Loss of Transparency

Recent reports by the New York Times (NYT) alleging that the FDA improperly blocked the publication of a study on the safety of COVID-19 and shingles vaccines, which concluded that the risk of adverse effects was very low, have further damaged regulatory credibility. The allegation that the regulatory agency, which should maintain transparency in public health information, attempted to control information in accordance with the administration's wishes has shocked both the academic community and the market. This lack of communication and information control ultimately undermines public trust in new drugs and vaccines and acts as a risk factor that increases the volatility of related companies' stock prices.

Future Prospects and Policy Risks in the Bio Industry

Kyle Diamantas, the Deputy Assistant Secretary for Food, has been appointed as the interim head of the FDA to succeed Commissioner Makary, but delays in regulatory operations due to the leadership vacuum are inevitable. The industry's sense of crisis is at its peak, with hundreds of CEOs of pharmaceutical and biotechnology companies sending letters urging the restoration of regulatory predictability. Investors should reflect the possibility of delays in FDA approvals in their portfolios and set political uncertainty in the U.S. biopharmaceutical industry as a top monitoring factor.