FDA Shakeup: Peter Marks’ Resignation Rattles Biotech Industry
Dr. Peter Marks, head of the FDA's Center for Biologics Evaluation and Research, abruptly resigned on March 30, 2025, effective April 55.
Marks cited disagreements with Health and Human Services Secretary Robert F. Kennedy Jr. over vaccine safety and transparency as the reason for his departure5.
Biotech stocks tumbled up to 10% following the news of Marks' resignation3.
Marks played a crucial role in Operation Warp Speed and advocated for accelerated development of cell and gene therapies5.
His departure leaves both of the FDA's principal drug review offices without permanent leadership5.
The resignation has sparked concerns about potential delays in drug reviews and approvals, particularly for innovative therapies3.
Industry experts worry that Marks' departure may undermine scientific standards and affect the development of new therapies5.
The FDA is already facing challenges due to recent layoffs and resignations of key personnel2.
Investors are expected to shift focus towards commercial companies and well-financed clinical-stage companies in the near term2.
Long-term impacts on the biotech industry remain uncertain, but concerns about regulatory flexibility and novel endpoint evaluations have increased2.
Sources:
2. https://adus.substack.com/p/weve-been-marked-layoffs-peter-marks
3. https://stockinvest.us/digest/biotech-stocks-stumble-as-key-fda-official-resigns-what-it-means-for-future-innovations
5. https://www.biopharmadive.com/news/peter-marks-resign-fda-kennedy-vaccines/743922/