Do you know something about the sale of counterfeit prescription drugs or off-label promotion of medical devices? What if you came across fraud committed by a clinical trial investigator or a case of product tampering? Do you know how to get in touch with the Food and Drug Administration if you knew about an alleged crime?
Well, the FDA is trying to encourage tipsters to get in touch. The agency recently created a special page on its Web site to report suspected criminal activity, and the info gets forwarded directly to the FDA’s Office of Criminal Investigation.
Here are activities the FDA’s OCI would investigate: illegal diversion of pharmaceuticals and other regulated products; Prescription Drug Marketing Act violations; schemes involving fraudulent treatments, cures or devices; New Drug Application fraud; crimes affecting the safety or integrity of the nation’s blood supply or the adulteration and/or misbranding of food; Internet facilitated criminal violations involving FDA regulated products; illegal importation of FDA regulated products, and crimes involving the manufacture, sale or distribution of unapproved FDA regulated products.
We asked an FDA spokeswoman what exactly prompted this initiative and whether any tips have actually been reported. The FDA responded that nothing prompted the move and that it “can’t comment on any of the e-mails we have received or any other communication we receive via other means.”