Sponsors must maintain strict oversight of CROs to avoid FDA enforcement action

Lack of oversight of contracted third parties is a common violation found in warning letters issued by the U.S. Food and Drug Administration (FDA) to sponsors to exercise appropriate oversight of entities conducting clinical research on their behalf. name, several foods and drugs said. lawyers at the November 2 meeting of the Food and Drug Law Institute (FDLI).

They also acknowledged that the clinical trial environment is becoming increasingly complex, with more and more non-traditional parties becoming study sponsors, making it difficult to understand which party is actually responsible for the trial. .

The lawyers also discussed some of the regulations that underpin the delegation of sponsor responsibilities to CROs.

Jonathan Walland, Pfizer’s senior legal counsel, acknowledged that the roles of sponsors and CROs are increasingly blurred as entities that conducted research, such as academic institutions, increasingly assume the role of sponsors. of studies.

There are also more patient advocacy groups and consortia taking on the role of sponsors. An example of the latter group is the Accelerating COVID-19 Therapeutics Interventions and Vaccines (ACTIV), a public-private initiative that aims to accelerate the development of promising new treatments and vaccines and bring them to the public.

Warning letters focus on lax oversight

Whoever they are, sponsors should be aware that under FDA regulations, they are ultimately responsible for the activities of their third parties, said Covington & Burling attorney Paula Katz, who previously worked at the Office of FDA Center for Dug compliance. Evaluation and Research (CDER).

Lack of oversight of CROs is a common theme in biomonitoring research follow-up (BIMO) warning letters to sponsors.

Failure to exercise strong oversight may result in a “Dear Applicant” request for information or the agency invoking its Application Integrity Policy (AIP), which is rare. Other options could be to seize the investigational product, seek an injunction, or impose civil penalties.

For sponsors, the most common BIMO violation found in fiscal year 2021 warning letters from CDER and CBER involved investigators. For CBER, 74 of 86 violations involved issues related to investigators, while for CDER, 327 of 465 violations involved clinical investigators.

For sponsors and CROs, some of BIMO’s most common issues were failure to submit an investigational new drug application (IND) and failure to select qualified investigators or reviewers.

For investigators, common observations were non-compliance with the investigation plan or deviation from the protocol, and the absence of an accurate history for the patients.

FDLI meeting

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