Blog: A Bill Would Prevent Drug Makers From Frustrating Generic Rivals
June 23, 2015
The Wall Street Journal's Pharmalot blog (Silverman) reported that "over the last few years, generic drug makers have claimed they have been denied access to samples of brand-name drugs that they need to conduct product testing. And the testing, of course, is needed to win FDA approval for their copycat versions." a bill has been introduced which would "require a generic drug maker to obtain samples by contacting the U.S. Department of Health and Human Services. Once HHS authorizes the request, the drug maker can seek samples from a brand-name drug maker. If denied a sample, a generic drug maker could seek triple damages in a lawsuit. ... The Fair Access for Safe and Timely Generics Act follows accusations that brand-name drug makers exploit an FDA program known as Risk Evaluation and Mitigation Strategies, or REMS, which are designed to boost patient safety. "