In the past week, President Biden revealed his American Jobs Plan, with important implications for domestic medical product manufacturing. The President also announced a new vaccination progress target, while the week marked a record level of vaccine supply. Please see details for these and other supply chain developments below:
- On March 29, President Biden announced that 90% of the adult U.S. population will be eligible for vaccination and 90% will have a vaccination site within five miles of home by April 19.
- On March 31, President Biden revealed details of the American Jobs Plan. Notably, the President calls on Congress to invest:
- “$50 billion to create a new office at the Department of Commerce dedicated to monitoring domestic industrial capacity and funding investments to support production of critical goods;”
- for future pandemics, $30 billion to “shore up [the] strategic national stockpile; accelerate the timeline to research, develop and field tests and therapeutics for emerging and future outbreaks; accelerate response time by developing prototype vaccines through Phase I and II trials, test technologies for the rapid scaling of vaccine production, and ensure sufficient production capacity in an emergency; enhance U.S. infrastructure for biopreparedness and investments in biosafety and biosecurity; train personnel for epidemic and pandemic response; and onshore active pharmaceutical ingredients;”
- $52 billion to increase access to capital for domestic manufacturers.
- On March 31, the FDA authorized several COVID-19 tests for over-the-counter (OTC) use without a prescription when used for serial screening. Notably, the agency authorized the testing of asymptomatic individuals when used for serial testing.
- On March 31, Johnson & Johnson (J&J) admitted a quality incident related to drug substance for its COVID-19 vaccine at Emergent BioSolutions Inc.’s Bayview facility, a site not yet authorized by the FDA to manufacture such drug substance. On April 2, the White House COVID-19 Response Team emphasized the issue did not impact any J&J vaccine doses that had been distributed. On April 3, J&J announced that it would assume full responsibility regarding the manufacturing of the drug substance for its COVID-19 vaccine at the Emergent facility by sending in dedicated leaders for operations and quality. It was reported that the move was directed by the federal government. The Emergent facility had also been producing AstraZeneca’s COVID-19 vaccine, and the federal government has directed AstraZeneca to move its vaccine production to another site. See CNN’s reporting here.
- On March 31, the U.S. Office of Special Counsel (OSC), an independent federal investigative and prosecutorial agency, sent President Biden a letter questioning the FDA’s practice of downgrading pharmaceutical inspection findings. The letter expressed special concerns over the FDA’s conduct involving a 2018 Merck Sharp and Dohme inspection.
- On April 1, the FDA revised the Moderna COVID-19 Vaccine Emergency Use Authorization to (1) clarify the number of doses per vial for the vials that are currently available, in that the maximum number of extractable doses is 11, with a range of 10 to 11 doses; and to (2) authorize the availability of an additional multi-dose vial in which each vial contains a maximum of 15 doses, with a range of 13 to15 doses that can potentially be extracted. The agency believed that the revisions would help increase the number of vaccine doses available.
- On April 2, the White House COVID-19 Response Team announced that in the past week, more than 33 million doses of COVID-19 vaccines were distributed to states, tribes, and territories and through federal channels, a record level of weekly vaccine supply.
- On April 2, the FDA provided an update on its COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) initiative, and listed “[e]valuating the current supply chain tracking, monitoring and assessment systems to identify gaps and challenges to help stakeholders improve supply chain resilience” as one of the areas identified for initial focus.
Please do not hesitate to contact us if you have any questions about these developments.