On 10 March 2020, as an updated response to the coronavirus (COVID-19) outbreaks in foreign countries, FDA announced that it is, effective immediately, postponing most foreign inspections through April 2020. Mission-critical inspections outside of the United States will still be evaluated on a case-by-case basis.
FDA stated that its position was based on various contributing factors, including:
- State Department Level 4 travel advisories prohibiting U.S. government employees from traveling abroad;
- Centers for Disease Control and Prevention travel recommendations;
- Access restrictions being imposed on foreign visitors by certain countries;
- Guidance from the Office of Personnel Management;
- Efforts to protect the health and safety of government employees; and
- FDA’s ability to maintain oversight of foreign manufacturers and imported products via alternative regulatory tools and methods.
FDA identified the following measures and alternative tools it has at its disposal to ensure the health and safety of the medical products entering the United States:
- Denying entry of unsafe products in to the U.S.;
- Increasing physical examination at the U.S. border, which may include product sampling;
- Reviewing a foreign manufacturer’s previous compliance history;
- Utilizing information sharing from foreign governments through mutual recognition; and
- Requesting records directly from manufacturers “in advance of or in lieu of” on-site drug inspections.
FDA’s statement noted that the agency was aware that the decision to postpone foreign inspections could impact pending applications that require an FDA pre-inspection, however the statement did not provide any additional information on how the agency plans to proceed with pre-market review in such cases. It is possible FDA could exercise discretion on a case-by-case basis to approve products based exclusively on a desk review. This, and other creative alternatives FDA may utilize, are discussed in more detail in our coronavirus article series on Emergency Use Authorizations and supply chain challenges.
FDA also indicated that it will continue its work with U.S. Customs and Border Protection to seek out FDA-regulated products that are in violation of the Federal Food, Drug, and Cosmetic Act (FDCA) and applicable regulations. In doing so, FDA will rely on its authority to refuse the importation of any FDA-regulated products that “appear” to violate the FDCA or its implementing regulations. To aid the agency during this time, FDA stated that it will adjust risk scores generated by the agency’s import screening tool (PREDICT), as necessary during the COVID-19 outbreak. This may lead to an increase in physical examination and/or sampling of products from high-risk areas. One consequence of this and something companies should take into account for the time being is an increase in the amount of time it takes for U.S. Customs and FDA to inspect, test, process, and release products entering the United States. FDA stated it would also continue to closely monitor indications of port shopping and cargo diversion.
As this situation evolves — particularly the extent of the spread of the Coronavirus in the U.S. — we will continue to monitor FDA’s stance on foreign and domestic inspections, and the agency’s response to the COVID-19 outbreak more broadly. Please contact us if you have any questions.
Authored by: Ted Wilson, Michael S. Heyl, James Johnson, Jodi K. Scott, Scott Kaplan, Seth Olson, Daniel Roberts