Just before the New Year holidays, the FDA announced it was suspending non-mission-critical domestic and foreign inspection activities. The FDA amended the EUA of the Moderna COVID-19 vaccine recall. The Center for Drug Evaluation and Research has released its annual report. This week, the Senate HELP Committee approved the appointment of Dr. Robert Califf as Commissioner of the FDA. The senators introduced legislation that would require certain foreign establishments to register with the FDA. Please see details of these and other supply chain developments below:
- On December 29, the FDA implemented changes to its inspection program due to record levels of COVID-19 infections. National mission-critical inspections will continue until January 19, while “some inspection activities” have been temporarily postponed. Mission-critical foreign inspections will continue; however, the agency will reassess feasibility if travel restrictions warrant. The program of priority surveillance foreign inspections which was to begin in February 2022 has been interrupted. It is likely that the FDA will not conduct any uncritical inspections, domestic or foreign, until the United States has passed the peak of the current omicron wave.
- January 4, HHS amended its declaration under the Public Preparedness and Emergency Preparedness Act (PREP) to include pharmacists and certain pharmacy trainees as “qualified persons” who can administer flu vaccines in states where they are not not authorized or certified. The PREP Act allows the Secretary of HHS to issue a statement and grant immunity from liability to such individuals.
- On January 5, White House Press Secretary Jen Psaki and Port Envoy to the White House Supply Chain Task Force John Porcari tenuous a briefing on the progress of supply chain improvements and new actions to come. Porcari reported 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 tax on long-lived empty containers. Porcari stressed that procedures are in place to prioritize the distribution of medical supplies. One such procedure is to “bulk stow” medical supplies on ships for easy identification and retrieval. He also discussed the impact of the omicron variant on operations and the procedures in place to deal with any disruptions.
- On January 7, the FDA amended the EUA of the Moderna COVID-19 vaccine recall. The agency authorized the administration of the booster dose five months (previously six months) after the primary vaccination of the vaccine.
- On January 10, the FDA Posted draft guidance, “Notification to the FDA of a Permanently Discontinuing or Discontinuing Manufacture of a Device Under 506J of the FD&C Act”. These draft guidelines, authorized under the CARES Act of 2020, are intended to prevent shortages of medical devices before and during a public health emergency and to provide a mechanism by which manufacturers notify the FDA of their intention to cease or suspend production. The draft guidelines apply to “devices essential to public health during a public health emergency, including those that are essential to life, sustaining life or intended for use in the medical care of emergency or during surgery” or “devices for which the FDA determines information about possible significant supply disruptions are needed during or before a public health emergency. Comments are due no later than 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 drug and device establishments to register with the FDA whether or not the drug or device undergoes further processing at a separate facility outside the United States. States before being imported into the United States. The goal is to give the FDA greater regulatory oversight authority to not only monitor products entering the supply chain and determine shortages, but also ensure that products are safe for the public. The Bill has been referred to the Health, Education, Labor and Pensions (HELP) Committee.
- On January 13, the Senate HELP committee vote 13 to 8 to advance the President’s nominee for FDA Commissioner Dr. Robert Califf. His confirmation hearing took place on December 14, 2021. The nomination now goes to the Senate for a final vote and confirmation.
- FDA Center for Drug Evaluation and Research (CDER) published its annual report, “Advancing Health Through Innovation: New Drug Therapy Approvals”. The report highlights CDER approvals of new therapies, biosimilars, and new indications for approved products. A post-marketing safety surveillance review is also included. The number of products approved (50) was above average despite the pandemic-related challenges, with more than half (27) being first-line drugs. CDER also met its action targets under the Prescription Drug User Fees Act for 49 of the 50 submissions.