In a Sept 20 2005 speech by FDA Deputy Commissioner for Medical & Scientific Affairs Scott Gottlieb, he confirmed that, “on Aug 31, we busted up a Lipitor counterfeiting and smuggling operation that was trafficking almost $50 mln worth of the drug.” [See prior press release of Sept 23 2005, for the 1st portion of this series reporting on his speech.] Counterfeits are “a real public health threat. As we have seen from the counterfeit cases that we’ve already encountered, in many cases solved and put people in jail, counterfeit drug products may contain only inactive ingredients, they may contain incorrect ingredients, improper dosages, sub-potent or super-potent ingredients, or they may be contaminated,” Gottlieb says. The counterfeits “result in risks to patients’ health, either risk to their safety directly if the products are dangerous. Or risks from people suffering from complications from the many diseases that prescription drugs can treat today -- but that the counterfeit versions cannot. With these more sophisticated drug counterfeit operations, FDA and all law enforcement activities that are partnering with us need to be even more effective in meeting these new challenges,” he notes.
