Unapproved devices hit the FDA Radar Screen

The FDA recently announced that it had filed for a permanent injunction against Endotec Inc. of Orlando, Florida to stop the illegal distribution of unapproved total joint replacement devices. The lawsuit alleges that the company has carried out the illegal distribution of the devices since March 15, 2002, despite the FDA’s warnings that these actions were illegal. This enforcement activity follows increased FDA awareness and resolve to take action against manufacturers of marketed unapproved new drugs. In 2003, after several decades without any apparent real enforcement, the FDA issued a Draft Compliance Policy Guide concerning marketed (but) unapproved drugs, declaring again that the drugs are illegal and that the FDA would exercise its enforcement discretion. There are hundreds if not several thousand prescription drugs on the market which have never obtained FDA approval in any form, yet year after year are unknowingly prescribed by physicians and taken by patients. Fortunately, the FDA in recent years has stepped up its enforcement efforts, even this month taking action against a manufacturer of unapproved dental drugs.