Since our last update, the Senate confirmed Dr. Robert Califf as commissioner of the U.S. Food and Drug Administration. The FDA resumed domestic and foreign inspections. The agency also published a proposed rule to update device current good manufacturing practice requirements related to the Quality System (QS) Regulation and moved forward with development of national standards for wholesale drug distributors and third-party logistics providers. The Office of Pharmaceutical Quality also released its annual report.
Please see details for these and other supply chain developments below:
- On February 7, the FDA resumed planning and conducting domestic surveillance inspections. The agency also continues to conduct both foreign and domestic mission-critical inspections, as well as remote assessments. The FDA continues to proceed with previously planned foreign surveillance inspections in countries that have received country clearance and are within the Centers for Disease Control and Prevention’s Level 1 or Level 2 COVID-19 travel recommendation. The FDA reports that planning for additional foreign surveillance inspections is ongoing, with an anticipated goal of conducting foreign prioritized inspections starting in April.
- On February 3, the FDA announced the availability of a proposed rule, “National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers,” as directed under the Drug Supply Chain Security Act. The proposed rule would establish standards for all state and federal licenses issued. Comments are due by June 6, 2022.
- On February 17, Dr. Robert Califf was sworn in as the commissioner of the FDA. Califf, a cardiologist by training, previously served as commissioner under President Barack Obama.
- On February 22, the Biden-Harris Administration met with stakeholders to discuss plans for major investment in the domestic supply chain for minerals and materials. These plans include sustainable and recyclable lithium extractions, element and mineral recovery projects, an update to mining rules and regulations, and strengthening the mineral stockpile. The implementation of the programs is also anticipated to create more domestic jobs.
- On February 22, the FDA Office of Pharmaceutical Quality (OPQ) released its “2021 Annual Report.” In 2021, the OPQ conducted 47 preapproval inspections and 21 mission-critical inspections and, by using alternative tools such as remote interactive evaluations, reduced the number of facilities requiring pre-approval inspection by 52%.
- On February 23, the FDA published a proposed rule that would amend the device current good manufacturing practice requirements of the Quality System (QS) Regulation to align more closely with the international consensus standard for devices by incorporating by reference the 2016 edition of International Organization for Standardization (ISO) 13485. ISO 13485 is an international standard specific to device quality management systems. Comments on the proposed rule are due by May 24, 2022.
- On March 3, the FDA published final guidance to industry, “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C,” which discusses preparations companies in a “distribution chain, including manufacturers and distributors, should consider making to establish recall initiation procedures; to ensure timely identification of, and response to, product problems that might lead to a recall; and to promptly issue recall communications and press releases or other public notices. It also discusses preparations firms in the distribution chain should consider making to ensure timely responses to a recall communication.” With some exceptions, the guidance applies across FDA-regulated products. The guidance also provides information on how entities can utilize the FDA to assist in their recall efforts.
Please do not hesitate to contact us if you have any questions about these developments.