Can We Talk? US FDA Remote Records Review Missteps Worry Industry

Paula Katz is quoted in the Pink Sheet regarding her record requests from the FDA on behalf of her clients. Ms. Katz says clients have asked the firm to reply to the official listed as the contact on the records request and “ask for a teleconference to discuss the request and make sure that the things you’re providing are effective and responding and that you understand the questions that are being asked.” She adds that some clients “have been very successful simply reaching out” to the agency. “They’ve found the FDA to be very approachable in discussing the request and negotiating the timelines for responding.”

When asked how she knows when the FDA is done requesting records and what its conclusions are, Ms. Katz says sometimes there are additional rounds of records requests. There are no constraints on follow-up requests, she explains, noting that “there aren’t regulations and the staff manual guide that exists really gives a lot of discretion to the individual centers and program areas on how to set up their individual records request programs.” She adds, “I think because this is the first time you’ve seen FDA really use this authority broadly, we don’t know yet how it’s going to used, for example, to prioritize re-inspections.”