There continues to be a focus by the government on investigating and bringing cases based on off-label promotion for both drugs and devices. Some are predicting that these cases have peaked and that the number of off-label cases will begin winding down soon. This seems unlikely, since the Department of Justice has increased the number of prosecutors assigned to work off-label cases. . Moreover, the states seem to be maintaining their own level of activity in this area. For example, last week the Commonwealth of Massachusetts announced a $1.35 million settlement against a medical device company based on allegations of illegal promotion, falsifying institutional review board documents and failing to disclose information to physicians regarding restrictions imposed on the use of the products.
Meanwhile, additional areas of focus are emerging:
In June, the HHS Office of Inspector General (OIG) issued a report recommending that FDA explore ways to expand its oversight of foreign clinical trials and inspect clinical trials in more countries. The OIG said that FDA may be unaware of some early-phase foreign clinical trials and likewise unaware whether trials are properly conducted.
More recently, it has been reported that several major drug and device manufacturers are under investigation into whether they made illegal payments to doctors and health officials in foreign countries. These investigations may stem from concerns, for example, that unusually large payments were made to physicians for overseeing the trials abroad, that consulting agreements might violate the Foreign Corrupt Practices Act, and that payments may have influenced the results. In many countries, such arrangements may blur distinction between who is and who is not a "foreign official." Not only are such investigations serious, but their mere existence or even the questioning of arrangements may endanger the integrity of key data from one or more sites, and thereby imperil an application for approval.