Former FDA Official Raises Legal Concerns Over CRL Publication Policy
In-house counsel for biopharmaceutical firms with pending unapproved drug or biologics applications must track this policy debate, as the FDA’s unprompted CRL publication rule carries unvetted legal risks that could disrupt development timelines and patient access.
The FDA has rolled out a policy publishing complete response letters (CRLs) for unapproved drug and biologics applications without prior formal rulemaking. Eva Temkin, a former acting policy director at the FDA’s Office of Therapeutic Biologics and Biosimilars and current life sciences regulatory attorney, cautioned the shift raises unresolved legal and regulatory questions, noting it was developed without adequate stakeholder input and could negatively impact drug development timelines and patient access. While she acknowledged the policy may be difficult to reverse, she urged the FDA to pause implementation, finalize the rule via formal rulemaking, and incorporate stakeholder feedback before moving forward. Biopharmaceutical in-house counsel should monitor upcoming rulemaking proceedings and assess potential impacts on their development pipelines.