Medical Products Supply Chain Week in Review – August 2021 #4

Last week, Roche announced a shortage of its drug Actmera/RoActmera, which is used to treat COVID-19. The company, however, does have a mitigation strategy that it plans to implement to lessen the impact. The White House COVID-19 Response Team reported on its plan to roll out booster shots. However, the official plan was pending FDA approval of the vaccines and CDC recommendation. Please see details for this and other supply chain developments below:

  • The Pfizer-BioNTech vaccine has received full approval by the FDA. While it is approved for use in individuals 16 years old and older, the vaccine still has emergency use authorization (EUA) for children 12 to 15 years of age and for use as a booster. The decision comes after months of evaluation of clinical data on safety and effectiveness as well as an assessment of manufacturing processes. The FDA is requiring continued post-market surveillance to ensure the safety of the vaccine.
  • On August 16, Roche issued a statement announcing an impending global shortage of its drug, Actemra/RoActemra (tocilizumab), used to treat patients who are critically ill with COVID-19. The drug was granted an EUA by the FDA in June 2021. Roche attributes the shortage to increased demand around the world, particularly in the United States, as well as continued issues with raw materials and manufacturing. While no definitive timeline is provided for restoration, in the interim, the company has developed alternative strategies, including the use of other drugs, to compensate for the impact to the supply chain. The WHO and Unitaid expressed concern about the shortage and encouraged Roche to consider “low- and middle-income countries” with allocation of current supply. In its statement, Roche promised to work with its global partners to ensure their patient populations are considered in Roche’s approach.
  • On August 18, the President reported in his press briefing that he is mandating vaccinations for nursing home staff and those who serve Medicare and Medicaid recipients. The President also has made American Rescue Plan funds available to supplement the salaries of education administrators who require their students to wear masks if their salary is cut by their governor.
  • On August 18, the White House COVID-19 Response Team announced the plan to begin administering booster doses to fully vaccinated adults beginning September 20, 2021, pending FDA authorization and CDC recommendation. The data used to support the decision has been made available to the public in the CDC’s Morbidity and Mortality Weekly Report. It shows variation in reduced vaccine effectiveness across all authorized vaccines; however, all vaccines provide continued protection against severe disease, hospitalization, and death. The U.S. will continue to support efforts to provide doses to and increase manufacturing in countries in need of vaccine.
  • On August 18, the Cybersecurity & Infrastructure Security Agency alerted manufacturers, consumers, and providers about a potential cybersecurity threat to users of medical devices that utilize the Blackberry QNX Real Time Operating System. The system is vulnerable to an outside entity denying user access and gaining control of affected systems. Blackberry is encouraging manufacturers to implement mitigation strategies as soon as possible.
  • On August 20, the FDA issued guidance on obtaining export certification for manufacturers of FDA-regulated products for export at the request of foreign governments or other entities. The certifications will comply with the regulations of Federal Food, Drug & Cosmetic Act Section 801(e)(4) and include human drugs (including a biological product), animal drugs, devices, or food. Special certificates will be issued for cosmetics.
  • The Center for Devices and Radiological Health (CDRH) announced it is now accepting radiation safety reports electronically. The goal is to increase efficiency in review of these events. Also, the CDRH Patient Engagement Advisory Committee announced a medical device recalls meeting on October 6, 2021 to discuss the ways the FDA and industry communicate with patients and the public about device recalls. It will also cover patient concerns about changes to their devices in response to a recall and how patient perspectives could be incorporated into the decision-making process for recalls.
  • On August 23, the FDA granted full approval to the Pfizer-BioNTech COVID-19 vaccine. The vaccine will be marketed as Comirnaty and is approved for individuals who are 16 years and older. The use for children ages 12 to 15 and the booster dose are still under an EUA and not included in the approval.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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