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Inspections Remain on Hold; FDA Collaborates with CDC to Develop a Process to Resume Program

May 28, 2020

Life science companies should consider offering FDA creative solutions for submissions that require pre-approval inspections.

US Food and Drug Administration (FDA) Commissioner Stephen M. Hahn, M.D. issued a statement on May 11 announcing that FDA will continue to postpone domestic and foreign routine surveillance inspections because of coronavirus (COVID-19) concerns. The continued delay for FDA’s routine inspection capabilities may been seen as a respite by some in the life sciences industry; however, these inspection limitations may adversely affect companies that are reliant on an FDA inspection as part of the premarket review process. It will be important for such companies to work closely with FDA on creative solutions to address these issues (suggestions provided below).

FDA’s May 11 Announcement

FDA initially announced the suspension of its routine inspection program on March 10 and 18, and announced a further extension of the suspension on May 11. In his May 11 statement, Commissioner Hahn indicated that FDA is collaborating with the Centers for Diseases Control and Prevention (CDC) to develop a process that would govern how and where to return to onsite facility surveillance inspections in accordance with White House guidelines. Commissioner Hahn noted that this would be a phased approach driven by scientific data.

Commissioner Hahn reiterated that the agency would continue to utilize other tools to assess product compliance, including alternative approaches to onsite inspections (e.g., desktop reviews). Moreover, Commissioner Hahn emphasized that FDA-regulated firms understand and appreciate their responsibility to ensure the safety of the products they manufacture. Accordingly, the agency believes firms will continue to ensure product quality and safety.

Impact on Submissions That Require Pre-Approval Inspection

While regulated firms may be sighing with relief for the break from routine inspections during COVID-19, other firms may need FDA inspections to have their submissions approved. Specifically, certain submissions require an FDA onsite pre-approval inspection, including manufacturing site change supplements for medical products approved through the Humanitarian Device Exemption (HDE), Premarket Approval (PMA), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or Biologics License Application (BLA) route. If a firm had an unsuccessful pre-approval inspection before COVID-19, FDA may require a re-inspection at the site to verify that actions taken to address FDA’s observations were effective.

On May 21, FDA issued a guidance document concerning PMA and HDE submissions that suggests some flexibility with pre-approval inspection requirements for certain PMA and HDE submissions in light of COVID-19:

  • Prior to COVID-19, changes in manufacturing sites for PMA and HDE devices required FDA pre-approval, which generally included successfully completing an onsite FDA inspection at the new manufacturing site.
  • The guidance document permits a manufacturing site change (e.g., possibly due to having to move a production facility to a region less impacted by COVID-19) withouthaving to obtain pre-approval from the agency (and thus no pre-approval inspection) so long as there is no “undue risk.”
  • FDA indicates no “undue risk” is created for a manufacturing site change when the “alternative site [has] established good manufacturing practices (i.e., compliance with 21 CFR Part 820) or during the public health emergency, to an alternative site that is ISO 13485 certified.”

The guidance document is limited to changes that address current manufacturing limitations or supply chain issues due to COVID-19-related disruptions. For all other changes that require a pre-approval inspection, FDA has not issued guidance providing flexibility to the onsite inspection requirement during the COVID-19 pandemic. As noted above, FDA suggested that it may utilize other methods in lieu of onsite inspections (e.g., record reviews).

Until FDA provides further guidance, firms that need pre-approval inspections but cannot take advantage of the guidance document should consider offering FDA a creative solution that provides FDA a pathway that makes regulatory sense, so that both the agency and the company can have their goals achieved. Such solutions might include

  • providing FDA with objective evidence to demonstrate the effectiveness of the quality system;
  • having accredited independent third parties evaluate the firm’s quality system and provide the report to FDA; and/or
  • voluntarily committing to additional post-market controls that evaluate the quality and safety of the product, and providing FDA with summary reports of the post-market data.

How We Can Help

Morgan Lewis helps companies around the world prepare for FDA inspections, assist and defend inspections, and respond to inspectional observations. We provide regulatory strategy and counsel on product submissions, including providing creative solutions to address FDA feedback on product submissions.

Contacts

If you have any questions or would like more information on the issues discussed in this LawFlash, please contact any of the following Morgan Lewis lawyers:

Washington, DC
Dennis C. Gucciardo
Michele L. Buenafe
Jacqueline R. Berman