Four U.S. senators – two Democrats and two Republicans – introduced a bill on Tuesday aimed at preventing big pharmaceutical companies from using safety rules to prevent generic drugs from coming to market.

Top leaders on the Senate Judiciary Committee led by Ranking Member Patrick Leahy (D-Vt.) introduced the new legislation to combat anticompetitive practices by brand-name drug companies that delay entry of lower-priced generic drugs. The issue will also be the subject of a Senate committee hearing next week.

The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act would deter pharmaceutical companies from blocking cheaper generic alternatives from entering the marketplace. The bill is cosponsored by Chairman Chuck Grassley (R-Iowa), and Senators Amy Klobuchar (D-Minn.) and Mike Lee (R-Utah), leaders of the Subcommittee on Antitrust, Competition Policy and Consumer Rights.

Leahy said: “the high cost of prescription drugs is preventing access to necessary medical care, and I share their concern that many pharmaceutical products are simply too expensive for consumers. Pharmaceutical companies should be compensated for their important work developing life-saving treatments, but predatory practices at the expense of consumers are unacceptable. Drug affordability is a bipartisan issue that affects each and every one of us.”

The CREATES Act targets abusive delay tactics that are being used to block entry of affordable generic drugs. The first delay tactic addressed by the CREATES Act occurs when brand- name drug companies prevent potential generic competitors from obtaining samples of the branded product, so the generic company cannot perform the testing necessary to show that its product is equivalent to the brand-name product, a prerequisite for FDA approval.

The second delay tactic addressed by the CREATES Act occurs when brand-name manufacturers whose products require a distribution safety protocol (known as a Risk Evaluation Mitigation Strategy with Elements to Assure Safe Use, or “REMS with ETASU” ) refuse to allow generic competitors to participate in that safety protocol, again undermining the generic’s ability to gain FDA approval.

The CREATES Act allows a generic drug manufacturer facing one of these delay tactics to bring an action in federal court for injunctive relief (i.e. to obtain the sample it needs, or to enter court- supervised negotiations for a shared safety protocol). The bill also authorizes a judge to award damages to deter future delaying conduct.

The CREATES Act is intended to provide an efficient, tailored path for generic drug manufacturers to obtain relief so they can continue working to bring their lower-cost product to market. The Congressional Budget Office has estimated that similar legislation would save the government over $2 billion in direct savings over 10 years. The savings to consumers and private insurance companies would likely be far greater.

There is a similar bill in the House of Representatives which addresses the same issue but uses a different strategy. For example, it requires the generic company seeking a REMS drug to get FDA authorization to obtain the sample.

As an example of one of the REMS disputes which is public, Mylan Pharmaceuticals filed a lawsuit in 2014 against Celgene Corp, accusing it of using REMS to prevent generic copies of Thalomid and Revlimid to market.

The Senate Judiciary Committee’s antitrust panel will hold a hearing on its bill on June 21.The Pharmaceutical Research and Manufacturers of America, or PhRMA, which counts major drugmakers among its members, said it had no immediate comment. The Generic Pharmaceutical Association was pleased to see the bill introduced.