In the past week, the FDA revealed the future plan for its inspectional activities. In addition, President Biden announced a new July 4 vaccination target. Please see details for these and other supply chain developments below:
- On April 27, Medtech Insight posted an FDA document to a medical device firm, explaining the Office of Medical Device and Radiological Health Operations’ Remote Regulatory Assessment (RRA) program to determine medical device facilities’ compliance status. Under the RRA program, the FDA requests and discusses electronic documents through meetings with the facilities. Participation in an RRA is voluntary, and refusal to provide information requested during an RRA is not a refusal of an inspection under Section 704 of the Federal Food, Drug, and Cosmetic Act. RRA findings will be considered for future routine FDA workplans and will be a factor in deciding the need for an onsite inspection.
- On May 4, President Biden announced the target of 70% of the U.S. adult population to have one vaccine shot and 160 million U.S. adults to be fully vaccinated by July 4. The President also revealed that the government is prepared to vaccinate adolescents, should the FDA authorize a vaccine for that population.
- On May 5, the FDA issued a report, “Resiliency Roadmap for FDA Inspectional Oversight,” summarizing the agency’s inspectional efforts during the COVID-19 pandemic. Most importantly, the report outlines a plan for future oversight of the regulated industries. Based on the plan, the agency will take a risk-based approach to prioritize future inspections, and the report provides a chart of prioritization factors for each regulated product category. The report also outlines three possible near-term scenarios for the agency to resume standard operations, taking into consideration the uncertainty of the development of the pandemic.
In addition, the report reveals that the FDA will begin a multiyear modernization effort to further transform its IT infrastructure to better support innovative oversight approaches. The FDA is also establishing an agency-wide FDA Inspectional Affairs Council to plan and coordinate inspectional activities. - On May 5, the U.S. government announced its support for waiving intellectual property protections for COVID-19 vaccines, a proposal being negotiated at the World Trade Organization. The European Union countries are divided on this topic, with some pressing the U.S. and Britain to lift export restrictions on vaccines and related ingredients. See Reuters’ reporting here.
- On May 7, Pfizer and BioNTech announced the initiation of the rolling submission of a Biologics License Application for their COVID-19 vaccine in individuals 16 years of age and older, with a request for priority review.
Please do not hesitate to contact us if you have any questions about these developments.