WASHINGTON — On Thursday, the Food and Drug Administration plans to start publishing the names of pharmaceutical companies that have been accused of withholding samples of drugs from generic manufacturers, Commissioner Scott Gottlieb told STAT.
This is part of the Trump administration’s broader plan to bring down drug prices by fostering competition. In a speech Monday, Secretary of Health and Human Services Alex Azar highlighted this forthcoming action by the FDA as one way to “call out the manufacturers who may be abusing the rules that built our free market for drugs.”
Generic drug companies need these samples in order to confirm that their products are actually equivalent to the brand drug. But, Gottlieb has said, sometimes brand companies refuse to provide the samples, making an excuse that FDA safety-related regulations won’t allow it.