FDA vaccine head will step down in April after string of controversial decisions
Vinay Prasad is leaving his post as director of the Center for Biologics Evaluation and Research.
TL;DR
- Vinay Prasad, director of the FDA's Center for Biologics Evaluation and Research, will step down in April.
- Prasad's departure follows criticism from the biotech and pharmaceutical industries regarding the FDA's regulatory process.
- The FDA has reportedly denied or discouraged at least eight drug approval applications in the past year.
- Companies accuse the FDA of reversing previous guidance on supporting data for their applications.
- This has led to concerns that the unpredictable process could hinder the development of treatments for difficult diseases.
- A recent controversy involved the FDA discouraging UniQure from seeking expedited approval for a Huntington's disease treatment.