Lawmakers from both houses on Capitol Hill are taking aim at obstructionary practices used by brand-name pharmaceutical companies against would-be makers of generic drugs.
In the Senate, a bipartisan group comprised of members from the Judiciary Committee and its Antitrust subcommittee has introduced a change to generic drug legislation that would allow generic drugmakers to sue if a branded drug manufacturer blocks their attempt to bring a generic to market.
Senate Moves to Block Pharma Obstruction to Generic Drugs
Currently, one tactic that pharma companies use to delay a generic drug coming to market is to throw up safety issues as roadblocks. These drug companies are taking advantage of the Food and Drug Administration’s Risk Evaluation and Mitigation Strategy (REMS) program in a way that was never intended.
The proposed law, called the CREATES Act (Creating and Restoring Equal Access to Equivalent Samples, S. 3056), is authored by US Senators Mike Lee (R-UT), Amy Klobuchar (D-MN), Chuck Grassley (R-IA), and Patrick Leahy (D-VT).
CREATES Act Introduced by Bipartisan Committee of Senators
The CREATES Act aims to close the safety loophole by allowing manufacturers of generic drugs to use a lawsuit to leverage access to a drug sample or safety protocol negotiations.
Lee discussed the bill at a Senate Judiciary Subcommittee hearing by saying that the bill would ensure pharma company practices are “driven by competition, not anti-consumer actions.”
Lee said that, if passed, the generic drugs law would “potentially save consumers billions of dollars in prescription drug costs and allow consumers to focus on their health, rather than the cost of their prescriptions.”
House Representatives Propose Similar Generics Legislation
Earlier this month, the US House of Representatives introduced a similar bill that would attempt to tackle the REMS problem from a different angle. The FAST Act (Fair Access for Safe and Timely Generics, H.R.2841) is sponsored by Representative Steve Stivers (R-OH) and co-sponsored by nine other representatives – a mix of both Republicans and Democrats.
The FAST Act changes existing law by requiring a non-REMS pharmaceutical license holder to provide a sample of its medication for testing as a generic upon request. If the medication is subject to REMS, the generic developer must obtain authorization from the FDA to conduct testing and trials.