FDA to call out branded drugmakers for blocking generics
The FDA will launch a website to put brand drug manufacturers on notice if they block generic competition as part of President Donald Trump’s plan to tackle high drug prices, said Commissioner Scott Gottlieb. The site, to be updated on a continuous basis, aims to curb the practice of branded manufacturers limiting access to samples generic drugmakers need to develop copies.
The FDA received more than 150 letters from generic drugmakers about difficulties accessing product samples from brand manufacturers, according to HHS Secretary Alex Azar. Some brand manufacturers use Risk Evaluation and Mitigation Strategy (REMS) programs or specialty distribution programs to keep samples out of the hands of generic drugmakers.
