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The Covid-19 pandemic has resulted in substantial global morbidity and mortality as well as disruption of the economies of virtually every country.1 Some of this tragedy could have been averted with the development of deliverable, orally bioavailable, direct-acting antiviral therapeutics. Molnupiravir, the orally bioavailable prodrug of N4-hydroxycytidine (NHC), begins to address this need. (Richard Whitley, M.D., 2/10)

The FDA’s accelerated approval pathway has a potentially prominent champion — Robert Califf, the scientist President Biden has nominated to lead the FDA. This pathway opens the door to earlier approval of drugs aimed at serious conditions that fill an unmet medical need based on a surrogate endpoint, which can considerably shorten the time required to submit data to the FDA and expedite the agency’s review process. (Peter J. Pitts, 2/14)

On January 19, 2022, the Department of Health and Human Services, Office of Inspector General (“OIG”) released a favorable advisory opinion, OIG Advisory Opinion No. 22-01 (the “Opinion”), analyzing a proposed expansion of discount programs for low-income individuals. The Requestor, an owner of retail pharmacies, inquired about whether its pharmacies adding Medicaid enrollment as an eligibility category for its low-income discount program would constitute grounds for sanctions under the federal Anti-Kickback Statute (“AKS”) or the Beneficiary Inducements Civil Monetary Penalty (“CMP”) Provision. The OIG concluded that although the proposed arrangement would generate prohibited remuneration under the AKS (if the requisite intent were present) and the Beneficiary Inducements CMP Provision, the OIG would not impose administrative sanctions on Requestors in connection with the proposed arrangement. (Lisa Churvis, 2/15)