In the past week, President Biden announced a new vaccination progress target, while the Baltimore facility incident affected Johnson & Johnson’s vaccine delivery. In addition, the FDA issued a guidance document regarding inspection delays’ effect on generic drug exclusivity decisions. Please see details for these and other supply chain developments below:
- On April 5, the FDA issued Guidance: Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers. The guidance document clarifies that ANDAs will not automatically receive a complete response letter if the FDA cannot conduct an inspection because of COVID-19 travel restrictions. Whether the agency’s inability to conduct certain inspections will factor into 180-day exclusivity decisions will be determined on a case-by-case basis.
Historically, inspection delays have not qualified sponsors for an exclusivity forfeiture exception. As we reported in previous issues, members of Congress expressed significant concerns about the FDA’s approach to this issue. It is likely that the FDA issued the guidance document to demonstrate that it is addressing congressional concerns about ANDAs that are at risk due to postponed inspections.
- On April 5, the FDA issued an emergency use authorization (EUA) for the Symbiotica COVID-19 Self-Collected Antibody Test System, the first antibody test authorized for use with home-collected dried blood spot samples.
- On April 6, President Biden announced exceeding 150 million COVID-19 vaccine shots in the first 75 days of his Administration and that all adult Americans will be eligible to be vaccinated by April 19.
- On April 9, the White House COVID-19 Response Team announced that in the past week, more than 28 million doses of COVID-19 vaccines were distributed to states, tribes, and territories and through federal channels. The Response Team also revealed that Johnson & Johnson delivered under 2 million doses of vaccines in the past week and it expects a relatively low level of weekly dose delivery until the company secures an FDA authorization for the Emergent facility in Baltimore (we reported the Baltimore facility incident in our issue last week). With the FDA authorization, the company also expects a weekly delivery of up to 8 million doses.
- On April 9, Pfizer and BioNTech submitted EUA amendments to the FDA to expand the use of their COVID-19 vaccine to adolescents 12 to 15 years of age.
Please do not hesitate to contact us if you have any questions about these developments.