Several medium- and large-sized pharmaceutical companies have gotten themselves into more trouble with FDA. The agency sent warning letters to nine companies yesterday (Mar. 31, 2009) requesting them to halt the production and distribution of 14 unapproved narcotics (mainly painkillers) (see the FDA’s release). The companies are: Boehringer Ingelheim Roxane (Columbus, Ohio), Cody Laboratories (Cody, Wyoming), Glenmark Pharmaceuticals (Mahwah, NJ), Lannett Company (Philadelphia, PA), Lehigh Valley Technologies (Allentown, PA), Mallinckrodt Pharmaceuticals Group (St. Louis), Physicians Total Care (Tulsa, OK), Roxane Laboratories (Columbus, Ohio), and Xanodyne Pharmaceuticals (Newport, KY). The drug firms have 60 days to stop manufacturing these products and 90 days to stop distributing them before enforcement action is taken. According to the FDA release, “previously manufactured products may still be found on pharmacy shelves for a short time.”

I fully support FDA’s efforts to crack down on unapproved drugs in the marketplace. What I don’t understand is the delay in enforcement. Why do companies have two to three months to stop what they’re doing? In my opinion, they should halt production and distribution immediately. The chance that some of these unapproved drugs—meaning the products’ safety is uncertain—can still be purchased by patients is unacceptable.

Just last fall, two other companies (Baxter Healthcare and Hospira) received FDA warning letters for manufacturing unapproved versions of ophthalmic balanced salt solutions, which are used to irrigate the eye during cataract and other surgeries, and skin ointments made with the ingredient papain. FDA had received more than 300 reports of serious reactions to the eye-wash, and about 40 reports about the papaya creams, including some describing life-threatening allergic reactions. 

FDA set out in 2006 to crack down on unapproved drugs and their manufacturers with a compliance policy guide.  This initiative is a great idea but it seems to need more stringent rules. If a drug dealer on the street, for example, was arrested for possession and distribution of illegal narcotics, he wouldn’t be given a 60- or 90-day timeframe to stop what he’s doing. He’d be sent to jail immediately. I don’t see why companies have an advantage in this regard.

A list of other drugs marketed in the US without FDA approval. 

Read FDA’s warning letters.