Two prominent senators recently sent a letter to the Commissioner of the FDA on November 10, 2020, requesting him to provide certain information regarding the current state of conducting international inspections. Many of those within and supportive of the pharmaceutical industry applaud the efforts of these senators in shining a light on some elements associated with the current lack of surveillance and review of foreign facilities. The FDA has some processes and tools in place, but these may lag behind what other regulators and the industry itself is employing. Understanding the viable mechanisms of communications is critical to all stakeholders.
In this letter, it is noted, “FDA loosely defines mission critical inspections as those for products ‘used to diagnose, treat, or prevent a serious disease or medical condition for which there is no other appropriate substitute,’ or ‘have received breakthrough therapy designation or regenerative medicine advanced therapy designation,’ and it remains unclear what products may fall into this category.” What is fairly clear about this is that these “mission critical inspections” apply to only a small number of facilities and not the large number of facilities that supply the vast majority of products to the U.S. market. Additionally, there are a large number of facilities that have previously been inspected by the FDA and have received Official Action Indicated (OAI) status that do not meet the definition of mission critical that the FDA is not reinspecting. These companies may have completed all of the corrective actions required by the FDA and their internal GMP related programs, but the status may not have been changed as there has not been a reinspection. While many of the facilities have remediated in good faith, there may be some that continue to have objectionable conditions present and may still be shipping product to the U.S. market.
At this time, it is crucial that the FDA expedite its efforts to develop alternative approaches to the traditional on-site inspection paradigm. While there are challenges and it is understandable that there will not be a “one size fits all” answer from the FDA, governing bodies may consider some of the following:
- Partner with independent third-party consultancies to conduct inspections or consider accepting these inspections in lieu of an in-person inspection.
- Develop or utilize existing technologies to conduct actual remote inspections.
- Consider expanding the definition of mission critical to encompass other categories, such as those sites with a current unacceptable status that are still shipping to the U.S.
Congress, the FDA, industry, and consultants are all working towards the same end – which is ensuring that high-quality pharmaceuticals are available to the American people when they are needed. We know that it is unlikely that we will return to the normal that existed before the pandemic. We need to collectively plan for the new normal.
