By: Janet Woodcock, M.D., Acting Commissioner of Food and Drugs and Judy McMeekin, Pharm. D., Associate Commissioner for Regulatory Affairs
Over the past year, the U.S. Food and Drug Administration’s approach to foreign and domestic inspections for food and medical products has been both risk-based and deliberate. The COVID-19 pandemic required us to rework our business operations so that we could carry out our public health mission while protecting our workforce, and the workforces of those we regulate.
Food and medical product manufacturers of FDA-regulated products generally are required to have a quality management system, known as preventive controls systems for food safety plans in the food industry, in place to ensure that their products are suitable for the U.S. consumer. The FDA conducts inspections to verify that these quality management systems are in place and operating as required, and to note and mandate corrections when they are not functioning appropriately. While on-site inspections represent a key tool, they are one part among multiple components of a comprehensive approach to the oversight of FDA-regulated products.
During the pandemic, we have prioritized inspections by identifying those that are “mission-critical” on a case-by-case basis. This means that conducting the inspection was key to our public health mission and that the activity could not be accomplished in any other way. We have done this with careful consideration of many factors, including whether products:
- have received breakthrough therapy or regenerative medicine advanced therapy designations;
- are used to diagnose, treat, or prevent a serious disease or medical condition for which there is no other appropriate substitute;
- require follow-up due to recalls, or there is evidence of serious adverse events or outbreaks, including human or animal food safety concerns; and
- are related to our nation’s COVID-19 response (e.g., drug shortages).
Due to travel restrictions imposed in response to the global pandemic—implemented both at home and abroad—traveling to sites has been challenging, if not impossible in some situations. When we have been able to visit facilities in person, we have worked hard to protect the safety of our staff and others. In some cases, FDA investigators underwent required quarantine periods in various countries for 14 days prior to starting inspections, and again when they returned home.
In July of 2020, prioritized domestic surveillance inspections resumed using a rating system that the FDA developed to assist in determining when and where it is safest to conduct prioritized domestic inspections. The COVID-19 Advisory Rating system (COVID-19 Advisory Level) uses real-time data to qualitatively assess the number of COVID-19 cases in a local area based on state and national data. The resumption of prioritized domestic inspections is based upon location and COVID risk, not upon product type.
Employing a Wide Range of Oversight Tools
To extend our reach during the pandemic, the FDA created and implemented innovative approaches to facility oversight. When entering facilities for inspections was not feasible or advisable, we utilized the following:
- Compliance history reviews of facilities, including recalls and product complaints, to assist with prioritization.
- Leveraging information shared by trusted state, local and foreign regulatory partners through mutual recognition and confidentiality agreements.
- Remote assessments for individual program areas to evaluate facility records.
- Review of records and information requests to facilities in advance or in lieu of drug and biological product inspections, and/or to support regulatory decisions and actions.
- Use of sampling and analytical testing of FDA-regulated products both domestically and at the border.
- Refusing entry of unsafe imported products into the U.S.
Results of FDA’s Oversight Efforts
We continue to assess the ongoing efforts we are taking to execute regulatory oversight. The examples below highlight some of the results:
- An analysis of user fee metrics across our prescription drug and generic drug programs demonstrated that we have been able to take on-time actions to evaluate and close out these drug applications more than 90% of the time, meeting our review program performance commitments.
- Our import program worked with federal partners like the Centers for Disease Control and Prevention’s National Institute for Occupational Safety and Health, to enforce authorities provided under the Emergency Use Authorization for filtering facepiece respirators (FFRs). The efforts resulted in an import alert and the ultimate refusal of more than $1.2 million worth of products, preventing the proliferation of ineffective respirators being used by health care personnel. To address the shortage of masks for the general public, which are worn to help reduce the spread of infection, the team simultaneously established a way for allowing the reconditioning of these FFRs into general use facemasks.
- Based on increased sampling and analytical testing of products at the border, the FDA helped prevent potentially dangerous and subpotent hand sanitizers from entering the U.S. After identifying 50 manufacturers shipping hand sanitizers to the U.S. that had serious safety issues, including methanol contamination, or other concerns, we placed the hand sanitizers made by these manufacturers on import alert, facilitated recalls and alerted the public.
- To ensure that importers are meeting their obligations to verify the safety of food from foreign suppliers, we began using remote importer inspections under our Foreign Supplier Verification Programs (FSVP). We focused on importers whose onsite food facility or farm inspections were postponed due to COVID-19-related travel restrictions. This approach has ensured continued oversight of our foreign supply chains and enabled us to conduct previously assigned routine and follow-up FSVP inspections during this time.
- For oversight of clinical research, we’ve been able to conduct a mix of mission-critical, on-site inspections, and remote record reviews to help ensure product approvals/authorizations did not get delayed. This included inspections of clinical trials that support U.S. COVID-19 vaccine authorizations.
- Inspections and investigations were conducted in response to certain human and animal food recalls and foodborne outbreaks as part of our effort to investigate and remove potentially unsafe products from the marketplace.
- We used tools such as records requests, virtual assessments, remote interactive evaluations, and information from other regulatory agencies to ensure medical devices continue to meet our requirements for safety and effectiveness. In one case we placed a potentially harmful medical device on import alert without conducting an on-site inspection. We have also authorized important medical devices during the pandemic, relying on alternatives to on-site inspections, including the approval of the first ankle implant to treat avascular necrosis.
As we look to the future, the FDA will continue to leverage and maximize every available tool and resource to meet our inspectional responsibilities while achieving optimal public health outcomes.
We will continue to study how to incorporate additional data sets and insights, and new technologies and tools for facility oversight, including the further use of remote interactive evaluations (e.g., remote livestreaming video of operations, teleconferences or screen sharing), and will work with industry to expand their use.
In concert with these efforts, we are pursuing agency-wide preparedness efforts for resuming a more normal state of operations, which will factor in how best to address inspectional activities that were paused due to the pandemic.
As we continue to navigate the challenges posed by this unprecedented public health emergency, we remain steadfast in advancing our mandate to protect and promote public health and ensure that the products we regulate are safe and of high quality for all Americans.