Medical Products Supply Chain Week in Review August 31, 2021

Medical Products Supply Chain Week in Review – August 31, 2021

Last week, the White House COVID-19 Response Team encouraged school systems to implement a layered approach to prevention as schools return to in-person learning. Moderna submitted a Biologics License Application (BLA) for its vaccine. The Biden Administration seeks to tackle supply chain issues due to the COVID-19 outbreak in Vietnam. Please see details for this and other supply chain developments below:

  • On August 24, the White House COVID-19 Response Team in its press briefing reported that we are still in the “pandemic of the unvaccinated.” While daily vaccinations are up 70% compared to mid-July, cases still increased, with the unvaccinated experiencing a 17-times higher rate of hospitalization. The response team also highlighted the availability of three monoclonal antibody treatments that have been authorized by the FDA. 
  • On August 24, the FDA posted two warning letters to overseas pharmaceutical manufacturers for current good manufacturing practice (CGMP) violations. One letter was based on records that an Australian facility had submitted in response to the FDA’s April 16, 2020 request for records; the other letter was based on the agency’s in-person inspection of a Japanese facility in February 2021. These developments demonstrate that the agency has been using a set of combined tools to actively enforce CGMP requirements with overseas manufacturers during the pandemic. 
  • On August 25, the Biden Administration released a fact sheet on Strengthening the U.S.-Vietnam Comprehensive Partnership on the heels of a visit by the Vice President to Vietnam. Vietnam serves as a top export market globally, and due to the COVID-19 pandemic, supply chain issues have severely impacted the retail markets as production of goods has decreased or in some cases halted due to infections. The U.S. policy includes supporting Vietnam in the fight against COVID-19 and ensuring health security. The Administration committed an additional 1 million doses of Pfizer vaccine, will provide COVID-19 technical and programmatic assistance, and will open a new CDC office in the region for monitoring activities. 
  • On August 25, Moderna submitted a BLA to the FDA for its COVID-19 vaccine for use in populations 18 years of age and older. Moderna received a fast-track designation and has been submitting data to the FDA. Data from the Phase 3 COVE clinical trial, submitted with the completed application, demonstrated 93% efficacy at six months after the second dose. Moderna has filed for an EUA for individuals 12–17 years of age. 
  • On August 25, the FDA issued an FAQ for device manufacturers of over-the-counter (OTC) products. These products are sold directly to consumers; however, the level of FDA review depends on the class of product. This information serves as a guidepost for manufacturers that intend to develop OTC products. 
  • On August 25, the FDA revoked the EUA for certain N95 masks manufactured by Shanghai Dasheng Health Products Manufacturing Co. Ltd. after the company lost NIOSH approval. The revocation is a result of the company’s failure to address deficiencies in its quality control procedures. A letter has been issued to alert health care providers and those responsible for procurement.
  • On August 26, Japan suspended the use of 1.63 million doses of Moderna’s COVID-19 vaccine due to reported contaminants in some vials. Moderna’s Spanish contract manufacturing organization, Rovi, which manufactures the vaccine for markets other than the United States, is investigating the issue. This development may draw more regulators’ attention to COVID-19 vaccine contract manufacturing. 
  • On August 27, the Biden Administration announced a new port envoy to the Biden–Harris Administration Supply Chain Disruptions Task Force. John Porcari, who previously served as the deputy secretary and COO of the Department of Transportation, will be responsible for working with the Department of Transportation to implement solutions to address import and export issues, including delays, product shortages, and costs. 
  • On August 27, the White House COVID-19 Response Team reported that, in addition to the mandated vaccinations in the government workforce, an increasing number of health care systems, colleges, and private industry are requiring vaccination. There have been 12.5 million first shots administered in August. As schools return to session, the team is encouraging the use of the layered approach to prevention, which includes vaccination, masking, and proper ventilation and has been shown to be most successful. 
  • The FDA announced a virtual public workshop, “Transparency of Artificial Intelligence/Machine Learning-Enabled Medical Devices.” The event will be held on October 14, 2021. The goals of the workshop are to gather information from various stakeholders to ensure transparency in the review process and facilitate a user-manufacturer dialogue on information sharing and practical product development.

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

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Nicholas Clarke
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Phone: 212.210.1222

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