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GAO Calls on FDA to Prepare to Resume Inspections of Drug Manufacturers

February 9, 2021

Predictably, the pandemic has taken a toll on the U.S. Food and Drug Administration’s (FDA’s) inspection program, which typically conducts more than 1,600 inspections of foreign and domestic drug manufacturing establishments each year. In a Report to Congressional Committees published on January 28, 2021, the U.S. Government Accountability Office (GAO) charged the FDA to review its approach to inspections in light of an increasing backlog to (1) ensure that inspection plans address issues presented by the backlog of inspections and (2) fully assess the agency’s alternative inspection tools to determine whether those tools could be used to meet drug oversight objectives while inspections are not possible.

In March 2020, FDA pressed pause on both foreign and domestic inspections, citing the safety of its employees as the reason for the measure. But despite the resumption of “mission-critical” domestic inspections in July 2020, GAO reports that the total number of FDA inspections of foreign and domestic establishments was 56 percent lower in fiscal year 2020 than the prior two years. According to the GAO report, the FDA conducted 52 domestic inspections from March to October 1, 2020, compared to about 400 inspections conducted during this same time period in the previous two years. With respect to foreign inspections, from March to October 1, 2020, FDA conducted three foreign mission-critical inspections. In contrast, from March to September of each of the prior two years, FDA conducted more than 600 foreign inspections.

During the halt on inspections, the FDA has relied on alternative inspection tools to oversee the manufacture of drugs. These measures include:

  • Inspections conducted by foreign regulators: As a result of the pause in inspections, FDA has leaned on information gathered during inspections conducted by some foreign regulators as a substitute for FDA inspections.
  • Requesting and reviewing records and other information: FDA has increased its use of its authority to request that establishments provide records in lieu of an inspection – in both the U.S. and internationally. According to the GAO report, in fiscal year 2020, FDA made 130 requests for records and other information to support preapproval applications. The GAO report notes that from March 1, 2020 to December 1, 2020, FDA placed nine foreign establishments on import alert for failing to respond to FDA’s record requests or for deficiencies identified in records provided to the agency.
  • Sampling and testing: FDA has utilized targeted sampling of high-risk and difficult-to-manufacture drugs from foreign establishments that had their inspections postponed. From March 1, 2020 to December 1, 2020, FDA placed 54 foreign establishments on import alert based on sampling.

While the agency contends that these alternative measures are not a comprehensive or long-term substitute for inspections, the GAO is concerned that a continued pause in inspections could lead to future delays in drug approvals. There is also concern that the halt in inspections could create a further backlog of drug facilities that have either never been inspected or that have not been inspected in the last five years. To combat this issue, the GAO recommends that the FDA first “identify, analyze, and respond to the issues presented by the backlog of inspections that could jeopardize its goal of risk-driven inspections.” Second, the GAO recommends that the FDA “fully assess the agency’s alternative inspection tools and consider whether these tools or others could provide the information needed to supplement regular inspection activities or help meet the agency’s drug oversight objectives when inspections are not possible in the future.”

The FDA has concurred with both of these recommendations and in response stated that it is actively tracking the list of sites that need to be inspected, and noted that the size of the backlog will depend on the extent to which alternative inspection tools are used. The agency plans to continue evaluating these tools in order to determine how they can be used to streamline and supplement regular inspection activities and to prioritize inspection sites when normal inspection operations are not possible.

For more information, please contact the professional(s) listed below, or your regular Crowell & Moring contact.

John Fuson
Partner – Washington, D.C.
Phone: +1.202.624.2910
Eryn Howington
Associate – Washington, D.C.
Phone: +1.202.624.2571