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Medical Products Supply Chain Weekly Review – October 2021 # 1 | Alston & Bird

Last week, AstraZeneca and Merck filed Emergency Use Authorization (EUA) applications for their COVID-19 drugs. The FDA has provided information to the public on a database repository of genetic variants and associated conditions. The United States, along with 135 other countries, have agreed to an overall minimum tax of 15%. Please see details of these and other supply chain developments below:

  • On October 5, AstraZeneca filed an EUA application for its COVID-19 long-acting antibody (LAAB) prophylaxis, AZD7442, composed of tixagevimab and cilgavimab. Although the LAAB combination is under investigation for prophylactic and therapeutic purposes, the EUA’s request was for its prophylactic use against symptomatic COVID-19. Two phase III trials have shown a reduction in the relative risk of symptomatic COVID-19 by 77% and 33%. The data suggests that the drug is also effective against variant strains. On October 11, AstraZeneca also released a press release revealing high-level results from another Phase III trial. The trial showed a reduction in the rates of severe COVID-19 or death in the treatment group, compared to the placebo group, in out-of-hospital participants with mild to moderate symptoms.
  • On October 5, the FDA released a final rule on the De Novo medical device classification process. The rule establishes procedures and criteria for submitting and withdrawing a De Novo application and how the FDA will assess the application. Based on the new rule, the agency updated the following guidance documents:
    • The final guidelines “FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals” provide sponsors with information on decision points and deadlines that the FDA will meet when reviewing a De Novo application. .
    • The final guide “De Novo Classification Process (Evaluation of Automatic Class III Designation)” provides guidance to sponsors whose device is automatically classified as Type III based on a determination that the device was not substantially equivalent to a predicate device via process 510 (k).
    • The final guide “Usage Fees and Refunds for De Novo Classification Requests” provides sponsors with information on De Novo classification requests requiring a fee, requests that are exceptions, and the refund process.
  • On October 7, the FDA’s Center for Devices and Radiological Health released a Description of Public Human Genetic Variant Databases, a repository of genetic variants and related diseases or conditions. The FDA’s goal is to help manufacturers develop tests for these diseases or conditions by providing FDA-recognized databases that contain data and claims, which can be used to support regulatory review of the FDA. The FDA considers the available databases to be scientifically valid.
  • On October 8, the United States, along with 135 other countries, approved an overall minimum corporate tax rate of 15%. Multinational companies have transferred their business infrastructure and interests to foreign countries with the lowest tax requirements. Countries with a stricter tax code, such as the United States, may benefit. The goal is to keep business interests in their home country and boost local economies.
  • On October 11, Merck filed an EUA application for its COVID-19 oral antiviral drug, molnupiravir. The request comes after interim results from the Phase III clinical trial demonstrated a positive benefit: severe hospitalization and death rates were reduced in the treatment group. If approved, the drug would be the first oral antiviral drug to treat COVID-19 that patients can take at home.
  • On October 12, the FDA announced it was withdrawing three guidance documents: “Temporary Policy for the Preparation of Certain Alcohol-Based Hand Sanitizers During Public Health Emergency (COVID-19)”, “Policy for the temporary composition of certain alcohol-based products for the hands Disinfectant products during a public health emergency” and “Temporary policy for the manufacture of alcohol to be incorporated into disinfectant products for the hands based on alcohol during the public health emergency (COVID-19). ”The manufacture of affected products must cease by December 31, 2021 and distribution by March 31, 2022. The agency determined that the urgent need to temporary orders no longer exist as the supply of alcohol-based disinfectants by “traditional” manufacturers can meet demand.

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Joan J. Dean

The author Joan J. Dean