FDA Sets the Stage for an Aggressive Year of Enforcement Action and Issues Warning Letters to Firms Selling Unapproved Ergotamine Drugs

On March 1, 2007, FDA announced that it issued 20 Warning Letters to companies marketing and distributing unapproved drug products containing ergotamine tartrate, a drug used to treat vascular headaches, including migraines. According to FDA’s press release announcing the enforcement action:

In addition to marketing these products without FDA approval, most of the companies receiving warning letters have omitted from their drugs’ labeling critical warnings regarding the potential for serious, possibly fatal, interactions with certain other drugs. Based on recent scientific information, the five marketed, approved versions of ergotamine-containing products have updated their labeling to include a box warning (the strongest agency warning) against using such products when also taking potent CYP 3A4 inhibitors, including some antifungal agents, protease inhibitors, and certain antibiotics.  CYP 3A4 is a metabolic enzyme that helps the body eliminate drugs or other chemicals.  Serious and life-threatening ischemia (a restriction in blood supply), including death and gangrene, have resulted when such products are used together.  Most unapproved versions of the drug do not carry these warnings.

FDA’s enforcement action is another example on a growing list of such actions taken to implement the risk-based enforcement approach described in the Agency’s June 2006 Compliance Policy Guide.  Moreover, it is the opening salvo this year for FDA to make good on its promise “to further accelerate its enforcement efforts against marketed unapproved drugs in 2007.”  As we recently reported in RAPS FOCUS, FDA’s stepped-up enforcement effort might be due to pressure from Congress and the threat of legislation addressing marketed unapproved drugs.