House Speaker Paul Ryan, R-Wis., said a compromise is in the works for a bill that aims to lower drug prices by helping generic competitors make cheaper alternatives.
Ryan said Thursday at an event at the law firm BakerHostetler that a compromise could be reached by committees working on the CREATES Act, which would clamp down on drug companies that delay generic competition. The legislation has not advanced in Congress despite strong bipartisan support. His comments were reported by several outlets.
The legislation aims to make it easier for generic drug companies to get samples of a brand-name drug so they can make a cheaper alternative of it.
A generic company needs thousands of samples of a branded drug to meet Food and Drug Administration testing requirements. However, a brand-name drugmaker can deny access to the drug by citing an FDA safety strategy that limits distribution. A drugmaker also can contract with a specialty pharmacy to prohibit any sales to a generic maker.
The CREATES Act would make it easier for a generic drug company to get a court ruling to provide the samples. Generic companies often sue to get the samples, but the goal of the bill is to speed up the process.
The bill also would give the FDA more leeway to structure the safety strategy to ensure that brand-name drugmakers can’t abuse it.
The FDA launched a new website Thursday that lists 52 drugs that generic companies have found difficulty getting samples of. The website is part of a greater effort by the Trump administration to crack down on drug prices.
