Bottle of Lies: The Inside Story of the Generic Drug Boom

When congressional investigator David Nelson found out about the motion filed by Maryland prosecutors, he wondered why he hadn’t been informed about it earlier. He had asked the FDA if the previous raid on Ranbaxy headquarters had to do with drug quality and the FDA told him it had nothing to do with that.

The Ranbaxy case reminded him of his experiences in the 1980s, when the FDA was overwhelmed with foreign products and full of agents willing to take bribes in gifts in exchange for turning a blind eye to potential violations. Nelson also noted another similarity: Many of the companies that were involved in generic drug scandals were headed by South Asians.

Dr. Harry Lever was a cardiologist who started to notice that his patients weren’t reacting well to generic drugs. This spurred him to research generic drugs and help his hospital compile a list of generic drugs to avoid.

Generic drugs were especially ineffective, or even dangerous, in the case of “narrow therapeutic index drugs,” where small differences in dose or concentration can have a significant impact on a patient’s response (241).

However, in the FDA’s tests of generic drugs, they continued to find generics to be bioequivalent with their name-brand counterparts.