Medical Products Supply Chain Week in Review December 23, 2021

FDA Authorizes Two Oral COVID-19 Drugs – Medical Products Supply Chain Week in Review

In the past week, the FDA authorized Pfizer’s and Merck’s oral antivirals for the treatment of COVID-19. The Biden-Harris Administration released the Trucking Action Plan. The CDC endorsed ACIP recommendation of preference for Pfizer-BioNTech and Moderna vaccine boosters. The new recommended Tris vaccine buffer leads to greater stability and requires no dilution. Please see details for these and other supply chain developments below:

  • On December 15, the FDA approved Eagle Pharmaceuticals’ abbreviated new drug application (ANDA) for vasopressin injection (20 units/mL multiple dose vials), a product with increased demand during the COVID-19 pandemic. The FDA stated that this approval—the first approval of an ANDA for this product—represents the agency’s commitment “to facilitating access to medical products to help address critical needs of the American public.” 
  • On December 16, the Administration issued its Trucking Action Plan with the goal of helping reduce supply chain disruptions as part of the initiatives fostered under the Supply Chain Disruptions Task Force. Globally, the plan seeks to implement steps to reduce barriers to commercial driver’s license (CDL) issuance; accelerate trucking apprenticeships; recruit veterans, particularly those with previous trucking experience, to the industry; and schedule listening sessions with the current workforce to implement improvement strategies. In order to promote immediate implementation, the plan also includes specific actions for 30, 60, and 90 days to implement the goals of the plan. 
  • On December 16, the FDA approved the use of Tris buffer for the manufacturing of Pfizer-BioNTech’s Comirnaty COVID-19 vaccine. This new formulation offers two key benefits to vaccination providers: (1) it increases the vaccine’s stability for longer at refrigerated temperatures; and (2) it does not require dilution by the provider before use. 
  • On December 16, the CDC endorsed recommendations by the Advisory Committee on Immunization Practices (ACIP) that the Pfizer-BioNTech and Moderna vaccines are preferred for booster use instead of the Johnson & Johnson vaccine. The ACIP met earlier in the day and based its decision on data that includes a review of effectiveness and adverse events. 
  • On December 17, the FDA announced that it is considering a program that would mandate sterilization changes to the master file pilot program for 510(k) cleared medical devices. The change applies to established category B or novel sterilization methods. In addition to manufacturers in the innovation challenge, current 510(k) holders can also participate in two previous programs where the FDA (1) challenged manufacturers to develop novel ways to develop alternatives to ethylene oxide; and (2) reduce emissions from ethylene oxide. If changes are employed to sterilization methods when ethylene oxide is used, participants can now refer to their master files as opposed to submitting a new 510(k). 
  • On December 20, Moderna announced that it continues to advance clinical trials to develop an omicron-specific vaccine to be used as a booster. It also noted that antibodies of its 50 mcg and 100 mcg booster doses demonstrated a 37-fold and 83-fold increase in antibody levels. Clinical trials for vaccines targeted to both omicron and delta are ongoing. 
  • On December 21, the Center for Devices and Radiological Health (CDRH) released a plan for how the CDRH intends to manage reviewer workload in 2022 based on the increase in total submissions. In 2021, the CDRH experienced an increase in medical device submissions for approval through traditional processes, i.e., PMA, 510(k), and Q-sub processes, which it handled via the implementation of novel approaches to review, including triage of cases, reallocation of staff and resources to COVID-19 products, use of contractors, and overtime. Despite these approaches, there are some review-timeliness issues that still need to be addressed. For devices other than in-vitro diagnostics, the CDRH foresees being able to comply with Medical Device User Fee Agreement (MDUFA) review timelines in 2022 despite the influx in medical products submitted for review. For in-vitro diagnostic products, the CDRH will also attempt to comply with promised MDUFA timeframes. Non-COVID products that were not prioritized during the pandemic will require extended review timeframes. Additionally, the presubmission request program will be reinstituted beginning January 1, 2022. 
  • On December 22, the FDA authorized Pfizer’s oral antiviral, Paxlovid, for the treatment of mild to moderate COVID-19 in adults and children 12 years of age or older (weighing at least 40 kg). This is the first oral antiviral treatment for COVID-19 to receive emergency use authorization. The authorization was based on data from the EPIC-HR trial, which demonstrated that Paxlovid significantly reduced hospitalizations and deaths from any cause in the studied population compared to those randomized to placebo. Paxlovid is a combination of nirmatrelvir and ritonavir—the former inhibits SARS-CoV-2 from replicating, and the latter slows down the breakdown of nirmatrelvir in the body. The FDA will continue to monitor the clinical trial data for the drug’s safety and efficacy.
  • On December 23, the FDA authorized Merck’s oral antiviral, molnupiravir, for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19 and for whom alternative COVID-19 treatment options are not accessible or clinically appropriate.

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

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