In recent warning letters to Glenmark Pharmaceuticals and Konec for marketing unapproved and misbranded nitroglycerin tablets, the FDA relies solely on drug listing information. The reliance is "notable," according to legal experts at Hyman, Phelps & McNamara.
Although drug listings have been cited before in warning letters, such mentions usually accompany manufacturing practice observations made by inspectors during a facility visit, explain Kurt Karst and Dara Katcher Levy. "Expect to see more Warning Letters directly from the Office of Compliance based solely on drug listing information," they write.
The tactic is all the more important given the FDA's Unapproved Drugs Initiative launched in 2006. In the final guidance Marketed Unapproved Drugs-Compliance Policy Guide, the regulator outlines how it intends to exercise its enforcement discretion while emphasizing that illegally marketed drugs require agency approval.