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Around the Web — 12.20.22

FDA yesterday released the findings and recommendations of an expert panel that evaluated the agency’s Tobacco Program. The panel assessed the Tobacco Program’s regulatory processes and agency operations relating to regulations and guidance, application review, compliance and enforcement, and communication with the public and other stakeholders. “This work is particularly critical as we focus on preventing initiation, while also helping people quit, especially the deadliest form of tobacco use, combustible tobacco products,” FDA Commissioner Robert M. Califf, MD, MACC, said in a statement. “Despite meaningful declines in cigarette use over the past several decades, nearly 500,000 Americans still die every year from cigarette smoking. Additionally, with more than 3 million youth reporting current use of a tobacco product in 2022, and e-cigarettes being the most used product, we risk another generation becoming addicted to these products.”

The U.S. District Court for the Western District of Oklahoma yesterday entered a  consent decree against the outsourcing facility Qualgen, its majority owner, and its director of quality following a complaint filed by the U.S. Department of Justice on behalf of the FDA. The complaint asserts that Qualgen introduced adulterated drugs that violated current good manufacturing practice requirements into interstate commerce.