In March 2020, the FDA postponed all inspections of domestic and foreign drug manufacturing facilities due to the COVID-19 pandemic.  However, drug products manufactured overseas are still entering the U.S. market, prompting some U.S. Senators to voice their concern.  On November 10th, two members of the Senate Health, Education, Labor, and Pensions (HELP) Committee sent a letter to the FDA asking about the Agency’s inspections and requesting information on how the FDA plans to take the necessary precautions to protect the health and safety of its own employees once in-person inspections resume.  In their letter to Commissioner Hahn, Senators Elizabeth Warren (D-MA) and Tina Smith (D-MN) also expressed concerns with the current tools being used in lieu of inspections (including remote inspections, records requests, and physical examination and testing of products arriving at U.S. borders) and how effectively these approaches address the risk related to the decline in all inspections (including for-cause inspections).  They cite both the heparin contamination scandal of 2008 and the recent NDMA contamination in sartans as examples of “failure of foreign manufacturing facilities to comply with regulatory requirements.”  They posed these questions to the FDA and asked for a response by November 24, 2020:

  1. How many foreign drug inspections has the FDA conducted since March 10, 2020?
    1. Please provide this information by type of inspection and the date it was performed.
    2. To what extent have these inspections identified unsafe products or manufacturing practices?
  2. How many scheduled foreign drug inspections have been postponed or eliminated since March 10, 2020? Please provide this information by type of inspection.
  3. Please describe in detail the alternative approaches that the FDA is using to ensure quality in cases where foreign drug inspections are postponed or canceled.
  4. Will the FDA retroactively conduct any foreign drug inspections it was forced to skip such as a result of the pandemic? If so, when and how?
  5. The FDA has stated that it considers several factors when determining what type of inspection would be considered “mission critical.” Please provide a detailed explanation of each of these factors.
  6. What factors will the FDA consider to determine when it is safe to resume its full inspection schedule?
  7. What safety measures have been implemented to protect FDA employees during inspections that are being conducted in-person?
  8. What additional resources are needed by the FDA to ensure that the agency is able to adequately conduct its foreign drug inspections during the pandemic?

At the end of their letter, the Senators discuss legislation that they had introduced in July 2020, the U.S. Pharmaceutical Supply Chain Defense and Enhancement Act, which would provide the Federal government with enhanced authorities and additional information regarding the nation’s supply chain.

We will keep you posted with respect to any developments in this area.