There’s a usual route for firms that want to market a generic drug: Buy samples of the brand-name version and run tests to show regulators that the generic is identical. If the firms can’t get their hands on the samples, they can’t get to the starting line.
A growing number of generic drug makers say they’re getting shut of the race because of a loophole in the law that gives their brand-name rivals a competitive edge.
At issue are brand-name drugs that are prone to abuse or pose such grave health risks that federal regulators approve them only if the drug maker agrees to tightly control their distribution — providing them only to hospitals, for instance.
Therein lies the rub. These restrictions, which are imposed by the Food and Drug Administration on a case-by-case basis, block the flow of drugs to the wholesalers that generic firms rely on for their must-have samples. Critics say the brand-name drug makers are using these restrictions as an excuse for denying competitors access to the products and warn the practice is bound to become more entrenched and widespread.