H.R.965: CREATES Act of 2019

The CREATES Act (H.R. 965) targets anticompetitive behavior that brand name drug companies have used to stifle generic and biosimilar drug entry. Drug companies can currently refuse to provide generic manufacturers with access to product samples that are needed to gain FDA approval and prevent generic and biosimilar manufacturers from joining a distribution protocol applicable to both brand and generic versions of the medicine. This bill would provide generic drug manufacturers with a recourse to address these abusive practices.

The Congressional Budget Office estimates that H.R. 965 would reduce federal spending by $3.3 billion and increase revenues by $600 million over the next decade.

S. 340 is the Senate companion bill introduced by Sen. Patrick Leahy.

Source