FDA recently published its “Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing Guidance for Industry” (“Guidance”) which provides suggestions on managing the potential risk of products being contaminated by SARS-CoV-2, the virus behind COVID-19 infections for drug and biological product manufacturers, 503B outsourcing facilities, and 503A compounding pharmacies.
The Guidance builds on the current Good Manufacturing Practices (cGMPs) regulations for drugs and biological products, which require personnel with an illness that could adversely affect drug safety or quality be excluded from direct contact with drugs and drug components used in manufacturing.[1] As the Guidance states, preliminary research indicating that SARS-CoV-2 “is stable for several hours to days in aerosols and on surfaces,” and that it has an incubation period of 2 to 14 days, which are both factors that increase the risk of spread and introduction into products. The actual health risk is hard to calculate – FDA itself notes that there have not been documented transmissions through pharmaceuticals to date. The regulatory risk, however, is an easier formula – FDA has a clear expectation that drug and biological product manufacturers evaluate the potential for COVID-19 contamination of their products under existing controls, or risk being out of compliance with cGMPs.
The Office of Inspector General (“OIG”) for the Department of Health and Human Services recently issued an Advisory Opinion that provides insight into how the agency evaluates arrangements that deal with the integration of technology, medicine, and patient monitoring under the federal Anti-Kickback Statute (“AKS”). In Advisory Opinion No. 19-02, OIG evaluated whether a pharmaceutical manufacturer could temporarily loan a limited-functionality smartphone to financially needy patients enrolled in federal health care programs. OIG concluded that the proposed ...
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