Sponsors need to maintain robust oversight of CROs to avoid FDA enforcement action
Lack oversight of contract third parties is a common violation found in warning letters issued by the US Food and Drug Administrations (FDA) to sponsors, who need to exercise proper oversight of those entities that conduct clinical research on their behalf, said several food and drug law attorneys at the Food and Drug Law Institute’s (FDLI) 2 November meeting.They also recognized that the clinical trial environment is getting more complex, with more non-traditional parties becoming study sponsors, making it challenging to understand which party is in fact responsible for the trial.
Attorneys also discussed some of the regulations underpinning the delegation of sponsor responsibilities to CROs.
Jonathan Walland, senior corporate counsel for Pfizer, acknowledged that the roles of sponsors and CROs are becoming more blurred as entities who used to conduct research, such as academic institutions, are increasingly assuming the role of study sponsors.
There are also more patient advocacy groups, and consortiums assuming 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 speed the development of promising new treatments and vaccines and bring them to the public.
Warning letters focus on lax oversight
Whoever they are, sponsors need to be aware that under FDA’s regulations, they are ultimately responsible for the activities of their third parties, said Paula Katz, an attorney for Covington & Burling, who formerly served in the Office of Compliance at FDA’s Center for Dug Evaluation and Research (CDER).
Lack of oversight of CROs is a common theme in Biomonitoring Research Monitoring (BIMO) warning letters to sponsors.
Failure to exercise robust oversight can result in a “Dear Applicant” information request, or the agency’s invocation of its application integrity policy (AIP), which is rare. Other options could be to seize the investigational product, request an injunction or levy civil money penalties.
For sponsors, the most common BIMO violation found in FY 2021 warning letters from CDER and CBER focused on investigators. For CBER, 74 out of 86 violations focused on problems related to investigators while for CDER, 327 out of the 465 violations focused on clinical investigators.
For sponsors and CROs, some of the most common BIMO problems were the failure to submit an investigational new drug application (IND), and the failure to select qualified investigators or monitors.
For investigators, the common observations were failure to follow the investigational plan or to deviate from the protocol, and a failure to have accurate case history records for patients.
FDLI meeting
