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

Last week, FDA Acting Commissioner Janet Woodcock testified before Congress on the role of the agency in the COVID-19 response and the way forward. The Administration reaffirms its commitment to combat the national and global COVID-19 pandemic. Please see details for this and other supply chain developments below:

  • On July 20, FDA Acting Commissioner Janet Woodcock provided extensive testimony during the hearing The Path Forward: A Federal Perspective on the COVID-19 Response before the Senate Committee on Health, Education, Labor, and Pensions. She detailed the role the FDA continues to play in inspections, compliance, and enforcement of products in the medical supply chain, the oversight of the Coronavirus Treatment Acceleration Program (CTAP) for the development of therapies, the continued surveillance of the emergency use authorizations (EUAs) issued for the vaccines and medical products, and monitoring to ensure human and animal food security. The testimony also included the recommendation that states hold vaccines that are near expiry or have expired in case expiry periods are extended based on stability data.
  • On July 22, the White House COVID-19 Response Team announced that the President has committed an additional $1.6 billion to the American Rescue Plan for continued support for testing capacity and outreach. Additionally, $100 million will be made available to rural health clinics for vaccine education and outreach. As the more transmissible Delta variant becomes more prevalent, and currently represents 83% of new cases, the focus will be on low-vaccination areas and populations.
  • On July 22, the FDA issued industry guidance regarding requirements for the submission of field alert reports (FARs) by applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs). The guidance provides details on who should submit a FAR, timing, the submission process, and where to submit a FAR.
  • On July 23, in a press briefing, the Administration discussed its continuing role in bolstering the global vaccine supply and announced that during the prior week, 22 million doses had been distributed to 23 countries. The Administration also reiterated its commitment to continue supporting the global vaccine effort.
  • On July 24, the State Department announced that Deputy Secretary of State Wendy Sherman would visit China over the weekend. While no specific topics of discussion were released, the department did indicate that there is an array of issues that are of interest. Of particular concern regarding the supply chain is the recent warning by the United States to entities doing business in the Xinjiang region because the region has been flagged due to continued human rights abuses.

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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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