Johnson & Johnson’s Actelion Pharmaceuticals, Celgene, and Gilead Life Sciences are all potentially blocking generic drug makers from accessing samples of their products, along with three dozen other drug companies — according to new data out Thursday from the FDA intended to publicly shame them for what it calls “gaming tactics.”
The new list, which also includes Novartis, Pfizer, Valeant, and a host of other companies, is part of the Trump administration’s efforts to lower prescription drug prices that kicked off with a presidential address Friday. While broader regulatory and legislative changes must go through a complex and often lengthy process, top health officials have used their bully pulpits this week to call out a number of companies for what they consider bad behavior.
Thursday’s announcement from the FDA focuses on branded companies that may be trying to delay competition from a generic competitor by blocking access to product samples the other company needs to test its own version of the drug — “gaming tactics,” as FDA Commissioner Scott Gottlieb said Thursday. Generic companies need somewhere between 1,000 and 5,000 doses of a drug to complete the studies that prove their product is equivalent with the branded one.
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Where are the insulin makers in all this? How have they escaped being listed?