Street View: FDA's new vaccine chief may raise bar for approvals

The U.S. Food and Drug Administration on Tuesday named oncologist Vinay Prasad, a frequent critic of the pharmaceutical industry, as the director of its Center for Biologics Evaluation and Research

HIGHER REGULATORY BAR

BMO Capital Markets says the appointment "casts another shadow" on the broader BioPharma sector

"While Prasad's positions are not anti-innovation, they are seemingly more restrictive and cautious for therapies that may have more nuanced risk/reward for patients" - BMO

RBC Capital analysts believe Prasad is "likely to focus more highly on the risk side of the benefit/risk equation"

Leerink Partners say Prasad's "skeptical mindset" could raise the bar for approvals of certain therapies, including cell and gene therapies on accelerated approval paths and certain vaccines

Brokerage Bernstein says the appointment signals a "likely shift toward a more conservative and evidence-focused regulatory stance"

"While this may help restore long-term confidence in FDA standards, it also introduces near- to mid-term risks to biopharma pipelines dependent on surrogate endpoints or expedited approvals" - Bernstein