Medical Products Supply Chain Week in Review September 14, 2021

Medical Products Supply Chain Week in Review – September 14, 2021

Over the last two weeks, the President signed Executive Orders requiring all federal employees and contractors to be vaccinated. The White House COVID-19 Response Team announced a $3 billion investment in the vaccine supply chain. The Biden-Harris Administration released its Biopreparedness Plan. The Center for Devices and Radiological Health released a tracking system for sponsors of premarket 510(k) submissions. Please see details for this and other supply chain developments below:

  • On August 27, the FDA revised the emergency use authorization (EUA) for Eli Lilly’s antiviral combination therapy of bamlanivimab and etesevimab, further limiting its use to areas with the combined frequency of variant resistance to the therapy equal to or less than 5%. 
  • On August 30, the FDA’s Center for Veterinary Medicine released a letter to veterinarians and retailers of animal health products soliciting assistance in preventing the use of ivermectin by the general public to treat COVID-19 in humans. Pharmacies are reporting a shortage of the drug due to the increasing number of prescriptions being written to treat COVID-19 (in August, the number had risen to 88,000 per week). Also, the Centers for Disease Control and Prevention (CDC) and poison control centers have seen an increase in individuals seeking treatment after taking the drug. The FDA previously released an FAQ on the use of ivermectin for COVID-19 and is asking that important resources about the safety of ivermectin be shared. The FDA also created signage to be used for this effort. 
  • On August 31, the Center for Devices and Radiological Health (CDRH) launched its tracking system for premarket 510(k) submissions. The portal, developed in response to the CDRH’s commitments under the Medical Device User Fee Act, provides sponsors with information on the status of their submissions. This development is welcome in light of criticism from the community regarding lack of communication with sponsors. 
  • On September 1, the FDA announced that it will hold a public meeting of its Vaccines and Related Biological Products Advisory Committee on September 17, 2021 to discuss the biologics license application for the Pfizer-BioNTech COVID-19 vaccine booster dose. 
  • On September 2, the White House COVID-19 Response Team announced a $3 billion investment in the vaccine supply chain to expand manufacturing. This funding will be distributed to manufacturers to add new production lines and facilities and to expand fill-finish capacity. 
  • On September 3, the Biden-Harris Administration released the plan, American Pandemic Preparedness: Transforming Our Capabilities, which was developed in response to the President’s Executive Order of a whole-of-government review and update of U.S. biopreparedness policies. The plan is organized under five pillars to address the critical needs to combat future pandemics and potential biological threats: Transforming Our Medical Defense (vaccines, etc.), Ensuring Situational Awareness (monitoring and warning), Strengthening the Public Health Systems (national and global response), Building Core Capabilities (PPE, stockpiles, supply chain security, etc.), and Managing the Mission (seriousness of purpose, commitment, and accountability). 
  • On September 9, the White House announced that the inaugural meeting of the U.S.-EU Trade and Technology Council (TTC) will be held September 29 in Pittsburgh. The TTC was established during the U.S.-EU Summit in June 2021 and is composed of 10 working groups committed to ensuring cooperation between regions, including promotion of supply chain security and export controls. 
  • On September 9, President Biden signed two Executive Orders requiring all federal employees and contractor employees to be vaccinated. The President also announced the Department of Labor will issue an emergency rule that will require private employers of at least 100 employees to mandate vaccination or weekly COVID-19 testing. Additionally, educators in federally funded programs will also have to be vaccinated. Each agency will implement its own program. For contractors and their subcontractors, the Safer Federal Workforce Task Force will provide guidance. The Order is subject to the protected exceptions by law. As for travel, fines for travelers with no mask will double.
  • On September 9, the FDA and the Federal Trade Commission issued warning letters to 10 companies for violations of the Federal Food, Drug, and Cosmetic Act. The companies have marketed dietary supplements that claim to be used to cure, treat, mitigate, or prevent diabetes. 
  • On September 9, the Department of Health and Human Services released a drug pricing plan in response to the President’s Competition Executive Order. The goals of the plan are to (1) make drug prices more affordable and equitable for all consumers and throughout the health care system by supporting drug price negotiation with manufacturers and stop unreasonable price increases to ensure access to drugs that can improve health for all Americans; (2) improve and promote competition throughout the prescription drug industry by supporting market changes that strengthen supply chains, promote biosimilars and generics, and increase transparency; and (3) foster scientific innovation to promote better health care and improve health by supporting public and private research and make sure that market incentives promote discovery of valuable and accessible new treatments, not market gaming. In particular, the policy would allow the department to negotiate drug prices for Medicare participants.
  • On September 9, the FDA released a statement about the collaboration between the FDA and the CDC that makes available to researchers bacterial and yeast isolates resistant to treatment. The Antibiotic Resistance Isolation Bank can be used to develop diagnostic tests and may be used in studies to support the FDA premarket notification application of such tests. The bank, created in 2015 as a result of goals stated in the National Action Plan to Combat Antibiotic-Resistant Bacteria, collects specimens from a variety of sources but verifies their purity and identity and performs antimicrobial susceptibility testing and whole genome sequencing before deposit and published availability.

Please do not hesitate to contact us if you have any questions about these developments.

Media Contact
Alex Wolfe
Communications Director

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