A coalition of 207 biotech leaders, including prominent industry figures, has expressed deep concerns over the FDA’s capacity following recent mass federal layoffs. The letter, addressed to Senate HELP Committee Chair Bill Cassidy, urges the government to quickly preserve and restore its core functions.
The FDA’s institutional knowledge is at risk due to the agency’s reduction in force and hiring freeze, which could lead to mistakes and inconsistencies in regulatory reviews. Biotech companies are already facing challenges, including conflicting feedback from review teams and disputes with foreign CROs (Contract Research Organizations). The authors of the letter argue that a well-staffed FDA is crucial for small, clinical-stage biotechs, which depend on investor funding to meet agency standards.
The letter coincides with recent commentary from former FDA Commissioner Janet Woodcock, who warned about the agency’s “slow-moving catastrophe.” The biotech leaders request the reinstatement of certain employees and unfreeze hiring for critical roles, such as head of human tissue and head of clinical evaluations. They also emphasize the importance of a flexible regulatory process that can adapt to new scientific discoveries.
The authors recognize the need for government efficiency but caution against centralizing all functions and over-systematizing the regulatory process. Instead, they advocate for maintaining deep agency expertise and experience to build an efficient FDA that Americans can count on. The letter includes a spot for other industry players to sign in support of the message.
Source: https://www.fiercebiotech.com/biotech/207-biotech-leaders-urge-senate-restore-fdas-key-functions-cite-funding-concerns-small