United States: FDA Suspends Non-Mission-Critical Domestic And Foreign Inspections – Medical Products Supply Chain Week In Review

Just before the New Year holiday, the FDA announced it that was suspending non-mission-critical domestic and foreign inspection activities. The FDA amended the EUA of the Moderna COVID-19 vaccine booster. The Center for Drug Evaluation and Research released its annual report. This week, the Senate HELP Committee approved the nomination of Dr. Robert Califf for commissioner of the FDA. Senators introduced legislation that would require certain foreign establishments to register with the FDA. Please see details for these and other supply chain developments below:

• On December 29, the FDA implemented changes to its inspection program because of record-high levels of COVID-19 infections. Mission-critical domestic inspections will continue through January 19, while "certain inspectional activities" have been temporarily postponed. Mission-critical foreign inspections will continue; however, the agency will reassess feasibility as travel restrictions warrant. The prioritized surveillance foreign inspection program that was set to begin in February 2022 has been halted. It is likely that the FDA will not conduct any non-mission-critical inspections, domestic or foreign, before the U.S. passes the peak of the current omicron wave. 
• On January 4, HHS amended its declaration under the Public Readiness and Emergency Preparedness (PREP) Act to include pharmacists and certain pharmacy interns as "qualified persons" who may administer influenza vaccines in states where they are not licensed or certified. The PREP Act enables the Secretary of HHS to issue a declaration and provide liability immunity to such individuals. 
• On January 5, the White House press secretary, Jen Psaki, and the port envoy to the White House Supply Chain Task Force, John Porcari, held a briefing on the progress of supply chain improvements and new actions going forward. Porcari announced that consumers received 97% to 99% of their packages on time or with minimal delays during the holiday season. Porcari added that the ports of Los Angeles and Long Beach are imposing a new fee on long-dwelling empty containers. Porcari emphasized that procedures are in place to prioritize the distribution of medical supplies. One such procedure includes "block stowing" medical supplies on vessels for ease of identification and removal. He also discussed the impact of the omicron variant on operations and the procedures in place to address any disruptions.
• On January 7, the FDA amended the EUA of the Moderna COVID-19 vaccine booster. The agency authorized the administration of the booster dose five months (previously six months) after the primary series of the vaccine.
• On January 10, the FDA issued draft guidance, "Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under 506J of the FD&C Act." This draft guidance, authorized under the CARES Act of 2020, is meant to prevent medical device shortages before and during a public health emergency and provide a mechanism by which manufacturers notify the FDA of their intent to cease or pause production. The draft guidance applies to "devices that are critical to public health during a public health emergency, including those that are life-supporting, life-sustaining, or intended for use in emergency medical care or during surgery" or "devices for which FDA determines information on potential meaningful supply disruptions is needed during, or in advance of, a public health emergency." Comments are due by March 11, 2022.
• On January 10, Senators Gary Peters (D-MI) and Susan Collins (R-ME) introduced S. 3449, a bill that would require foreign establishments of drugs and devices to register with the FDA regardless of whether the drug or device undergoes further processing at a separate establishment outside the United States before being imported into the United States. The goal is to provide the FDA with more regulatory oversight authority to not only monitor products introduced into the supply chain and ascertain shortages but also ensure the products are safe for the public. The bill has been referred to the Committee on Health, Education, Labor, and Pensions (HELP).
• On January 13, the Senate HELP Committee voted 13 to 8 to advance the President's nominee for commissioner of the FDA, Dr. Robert Califf. His confirmation hearing occurred on December 14, 2021. The nomination now goes to the Senate floor for a final vote and confirmation.
• The FDA's Center for Drug Evaluation and Research (CDER) released its annual report, "Advancing Health Through Innovation: New Drug Therapy Approvals." The report highlights CDER's approvals of novel therapies, biosimilar products, and new indications for approved products. A review of postmarket safety surveillance is also included. The number of products approved (50) was above average despite pandemic-related challenges, with over half (27) being first-in-class drugs. CDER also met its Prescription Drug User Fee Act action goals on 49 of 50 submissions. 

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