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.
For over a decade, taking a pill like Truvada every day has been the standard of...
