Roche’s Genentech, Gilead, Sanofi and other drugmakers weighed in on the FDA’s recent draft guidance on research inspections, with the companies calling for clarity and further commitment from the agency to be flexible with remote inspections.
Thousands of industry sites that run FDA-regulated research are inspected under the Bioresearch Monitoring Program, which may include both on-site FDA inspector visits or remote requests for data. Data integrity or other inspection violations can result in Form 483s or warning letters, which mean company management is notified in writing of “observations of objectionable conditions and practices.”
In comments on the draft from June that was required by the Food and Drug Omnibus Reform Act of 2022, Rasika Kalamegham, Genentech’s head of US regulatory policy, explained how transitioning the flexibilities around remote inspections, which were used frequently during the pandemic, “into routine practice was an explicit commitment made in the last user fees reauthorization commitment.”
“We therefore encourage the agency to examine its ability to enhance efficiency and improve the inspections process by adopting modern tools and technologies for inspections in a manner that maintains the integrity of the process,” she wrote in a letter on Monday.
Heidi Marchand, executive director of Gilead’s global regulatory policy and intelligence, also raised questions with the FDA about whether the guidance relates to mandatory or voluntary remote inspections. On the topic of remote inspections replacing on-site inspections, Marchand asked “if there are any instances whether an RRA [Remote Regulatory Assessments] may be conducted in-lieu of an inspection.”
Pujita Vaidya, Sanofi’s director of regulatory science and policy in North America, and Marchand both said they are seeking more clarity on how the FDA may require its inspectors to access some of the company’s electronic systems.
“Please clarify what is intended by ‘access’?” Marchand wrote. “For instance, whether an inspector should be provided with their own unique account to access systems and/or be allowed to view and access records via the establishment staff.”
While noting a “lack of information” in the draft on how the FDA plans to “modernize, optimize and streamline its approach to inspections,” Genentech’s Kalamegham also called for a longer notice period for US-based pre-approval inspections “to arrange for appropriate individuals to be onsite.”
Sanofi and Genentech also requested more information from the regulator about a line in the draft that says the agency may not always disclose specific reasons for conducting an inspection in its pre-inspection announcement to the sponsor.