Prasad takes over after Peter Marks, who resigned in March and was considered a strong advocate for fast-track approvals, especially for gene therapies for rare diseases. He was involved in the approval of the first gene therapy, the first cell therapy for cancer, and the first CRISPR gene-editing drug, among other things.
Marks was also a strong advocate for the FDA to be more flexible in reviewing these types of treatments, for which he received both praise and criticism.
Prasad a vocal critic
One of the most vocal critics is Vinay Prasad, who has publicly questioned Marks' decisions. The criticism includes, among other things, the approval of Sarepta Therapeutics treatment for Duchenne muscular dystrophy, Elevidys, as well as Mark's handling of corona vaccines.
– Peter Marks was one of the most dangerous, pro-pharma regulators of the 21st century, he wrote in a scathing article in March, where he also sends a sour message to the media:
- He is leaving and crafting a narrative that portrays him as a saint. That's natural. But what is shocking is that the media is so uncritical, and not honest about his actions. The same media that lied about lab leak, masks, and all things covid is lying about Peter Marks.
Unclear effect of the appointment
The stock market reacted strongly negatively to the news of the appointment, and stocks such as Sarepta and UniQure, fell by almost 30 percent. Several analysts believe that Prasad's appointment increases uncertainty in the industry, according to a report from Biopharma Dive. However, it is unclear to what extent.
Among other things, called Matt Phipps, analyst at William Blair, the announcement a “surprise” and commented that it stands in “sharp contrast to the themes and initiatives that have been put forward” by the new FDA chief Martin Makary, for example, his apparent support for faster approvals for certain treatments for rare diseases.
- There are clearly outstanding questions and increased uncertainty now, as we wait to see whether Dr. Makary or Dr. Prasad will have more impact on the guidelines and regulatory development requirements for these novel therapies, particularly in rare diseases, writes Phipps.