Food and Drug Law Institute’s Enforcement Conference Panelist Beth Weinman Noted in Pharma Intelligence
A Pharma Intelligence article discussed the Food and Drug Law Institute’s Enforcement, Litigation and Compliance Conference panel debate on the effects that policy changes at the US Department of Justice’s Consumer Protection Branch will have on companies subject to the Federal Food, Drug and Cosmetic Act.
The article quotes life sciences regulatory & compliance counsel Beth Weinman who expressed concern about the DOJ encroaching on traditional U.S. Food and Drug Administration authorities and about challenges that companies could face when they are subject to both an FDA consent decree and a DOJ criminal resolution.
“Enforcement is supposed to be calibrated…And this is a fragile ecosystem—we’ve seen in the pandemic what happens when there are shortages, what happens when there is lack of confidence in medical products. When I look at these agreements, and the Department of Justice has sole discretion to make determinations as to what the next step in criminal enforcement looks like, I worry, especially in the context of manufacturing practices,” said Beth.