• Dr. Vinay Prasad, an outspoken critic of the FDA, has been named the new director of the Center for Biologics Evaluation and Research (CBER), replacing Peter Marks.
• The appointment has led to concerns within the biotech industry, with biotech stocks experiencing a notable drop following the announcement.
• Prasad's past criticisms of accelerated drug approvals, vaccine policies, and gene therapies suggest potential for stricter regulatory oversight in the future.

Dr. Vinay Prasad, previously an epidemiology professor and a known critic of the FDA, has been appointed as the new director of the FDA's Center for Biologics Evaluation and Research (CBER). This division is responsible for overseeing the regulation of vaccines, gene therapies, and the blood supply. The appointment follows the resignation of Peter Marks, reportedly due to disagreements with Health Secretary Robert F. Kennedy Jr. Prasad's appointment has raised concerns within the biotech industry, particularly regarding potential changes in regulatory standards and approval processes, given his history of questioning FDA policies and specific drug approvals.

• What: Dr. Vinay Prasad, a hematologist-oncologist and known critic of the FDA, has been appointed as the director of the FDA's Center for Biologics Evaluation and Research (CBER).
• Who: Key individuals include Vinay Prasad, Peter Marks (former CBER director), Robert F. Kennedy Jr. (Health Secretary), and Marty Makary (FDA Commissioner). Organizations involved are the FDA, CBER, and various biotech companies.
• When: The appointment was announced in May 2025. Peter Marks resigned in March 2025.
• Where: The events are centered around the FDA headquarters in Washington D.C., and the impact is felt across the US biotech industry.

The appointment of Dr. Vinay Prasad as the director of CBER represents a significant shift in leadership and potentially in regulatory philosophy at the FDA. Prasad's history of criticizing the agency, particularly its accelerated approval processes and vaccine policies, suggests a potential for increased scrutiny and stricter requirements for new biologics and vaccines. The immediate negative reaction from the biotech industry, as reflected in the drop in stock prices, underscores the uncertainty and concern surrounding this appointment. Prasad's views on gene therapies, especially his criticism of the approval of Sarepta's Elevidys, indicate that this area may face particularly intense review under his leadership. The circumstances surrounding Peter Marks' departure, reportedly due to disagreements with Health Secretary Robert F. Kennedy Jr., further highlight the potential for political influence on the FDA's regulatory decisions.

It has become clear that truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies.

Despite its high cost and potential toxicity, the clinical benefits of Elevidys remain uncertain.

The FDA did nothing to speed gene therapy, other than talk about how they will use uncontrolled endpoints. But we want to speed effective gene therapy, not ineffective gene therapy. The FDA had no solution for that.

The appointment of Dr. Vinay Prasad to lead the FDA's CBER marks a turning point, potentially leading to stricter regulatory oversight of vaccines and biologic medicines. The biotech industry is closely watching how Prasad's past criticisms will translate into policy changes and whether his leadership will result in a more cautious approach to drug approvals. The future of gene therapy regulation, in particular, appears uncertain. Ongoing developments, including any policy announcements from CBER under Prasad's leadership, will be crucial in determining the long-term impact of this appointment.