Health Policy Check Up News

CREATES Act Legislation Could Empower Generic Drug Makers

If passed, the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act will permit generic pharmaceutical drug manufacturers to take direct legal action against branded drug manufacturers utilizing improper tactics that diminish fair competition between branded and generic drug manufacturers. While the CREATES Act (H.R. 2212/S. 974) has not yet been passed by Congress, it has bipartisan support in both the House and the Senate and has recently gained momentum.

The CREATES Act aims to decrease drug prices by motivating branded drug manufacturers to provide samples to generic drug manufacturers. In the event branded drug manufacturers do not provide samples, the CREATES Act would allow generic drug manufacturers to file a lawsuit in federal court and a judge would have the authority to require that samples be provided on commercially reasonable, market-based terms.

Generic manufacturers need the branded drug samples for legitimate reasons.  The practice of branded drug manufacturers refusing to provide necessary samples for generic drug manufacturers to understand the formulas for patented drugs and to perform the necessary tests to ensure that generic versions are safe and identical as required by the federal Food and Drug Administration (FDA) allows the branded drug manufacturers to maintain higher prices of the branded versions for their own benefit.  Providing the samples could pave the way for lower drug pricing.

Until recently, momentum has been stalled on this issue. It remains to be seen whether Congress can strike a deal with the branded pharmaceutical industry on this contentious issue

Generic drug manufacturers should contact Frier Levitt Government Affairs today to learn how government affairs and lobbying strategies can be used to promote enactment of the CREATES Act, and should contact Frier Levitt, the law firm, to access branded samples, if the CREATES ACT is passed.