Medical Products Supply Chain Week in Review – September 2021 #2

Alston & Bird

Last week, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) met and provided recommendations on the COVID-19 booster dose, and yesterday the FDA authorized the booster dose for certain individuals. A consent decree was entered for an outsourcing facility. The FDA revised its policy on face coverings, face masks, and other related PPE. Please see details for these and other supply chain developments below:

  • On September 14, Regeneron Pharmaceuticals Inc. announced that the U.S. government will purchase an additional 1.5 million doses of REGEN-COV, which previously received emergency use authorization (EUA) for the treatment of certain COVID-19-infected patients and for post-exposure prophylaxis in select populations.
  • On September 15, Eli Lilly and Company announced that the U.S. government will purchase 388,000 doses of etesevimab, which was previously authorized as a COVID-19 treatment for emergency use.
  • On September 17, the FDA revised Guidance: Enforcement Policy for Face Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency. The policy allows for use of non-NIOSH-approved disposable face masks, face coverings, face shields, surgical masks, and respirators if they do not create an undue risk irrespective of purpose, whether it be for a medical or public source control. Face masks and face coverings that have been stockpiled are also approved for continued use. The policy, which can be used through the end of the declared public health emergency, applies to filtering facepiece respirators (FFRs) approved under the Federal Food, Drug, and Cosmetic Act (FDCA).
  • On September 17, the VRBPAC recommended an EUA for Pfizer-BioNTech’s COVID-19 vaccine booster doses for individuals 65 years of age and older or those who are at high risk of severe COVID-19. The committee recommended that the additional dose be administered at least six months after the two-dose series. The CDC’s Advisory Committee on Immunization Practices will meet September 22–23 to discuss the booster shot. On September 22, the FDA authorized the booster dose for the Pfizer-BioNTech vaccine for use in individuals 65 years of age and older, those at high-risk of severe COVID-19, and health care and frontline workers who are exposed to COVID-19 in their line of work. The booster dose is to be administered at least six months after completion of the primary series.
  • On September 17, the U.S. District Court for the Middle District of Florida entered a consent decree between the government and Premier Pharmacy Labs Inc., an outsourcing facility, for compounding drugs, including sterile drugs, under insanitary conditions and in violation of current good manufacturing practices. Under the consent decree, the company cannot resume production until the FDA finds that the outsourcing facility has taken appropriate action to comply with the FDCA. 
  • On September 20, Pfizer and BioNTech announced positive topline results from a pivotal trial of their COVID-19 vaccine in children between the ages of five and 11 years old. According to the companies, a two-dose vaccine regimen (10 µg doses) proved to be well tolerated and produced robust neutralizing antibody responses. Based on the topline results, Pfizer and BioNTech plan to seek an EUA for the vaccine in children between the ages of five and 11 years old.

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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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