Generic Drugs May Not Be As Safe Or Effective As Thought

The U.S. Food and Drug Administration states that it holds foreign plants to the same standards as U.S. drugmakers, but Eban’s new book, Bottle of Lies, challenges that notion. She writes that the FDA often announces its overseas inspections weeks in advance, which allows plants where generic drugs are made the chance to fabricate data and results. But what Hatch-Waxman did that really ignited the generic-drug revolution is it gave the companies an incentive: The incentive was called “first to file,” and it said if you are the first company to submit your application — and literally first by the minute or the second — and you get approved, you’re going to get six months of exclusivity on the market to be the lead and only generic, and you’re probably going to be able to sell your drugs at about 80 percent of the brand-name price.

Source: www.npr.org