01.29.19

Leahy Cosponsors Bipartisan Legislation to Crack Down on Anticompetitive Pay-for-Delay Deals

U.S. Senator Patrick Leahy (D-Vt.) joined bipartisan legislation introduced by Senators Amy Klobuchar (D-Minn.) and Chuck Grassley (R-Iowa) to bring down the skyrocketing prices of prescription drugs. The Preserve Access to Affordable Generics and Biosimilars Act would limit anticompetitive pay-for-delay deals that prevent or delay the introduction of affordable follow-on versions of branded pharmaceuticals. The bill extends the reach of their prior legislation – the Preserve Access to Affordable Generics Act – to cover pay-for-delay deals affecting biosimilar and interchangeable biologics, in addition to the generic drugs already covered under the prior bill. Biologics are a fast-growing class of medicines that are more expensive than traditional pharmaceutical products. The use of “pay for delay” deals—the practice in which drug companies use pay-off agreements to delay the introduction of cheaper substitutes – could make some critical prescriptions unaffordable for patients and impose significant costs on our healthcare system.

“For too long, unfair and manipulative corporate tactics have kept the costs of prescription drugs artificially high and out of reach for many Americans,” said Leahy. “Through the bipartisan Preserve Access to Affordable Generics and Biosimilars Act, which would end pay-for-delay schemes, and the bipartisan CREATES Act, I believe Congress now has both an opportunity and an obligation to take meaningful steps to lower prescription drug costs by billions of dollars.”

“I’m glad that we have new bipartisan support for our legislation to spur competition and drive down prices, helping to ensure patients can access the medications they need to improve their quality of life,” said Klobuchar. “Without competition, U.S. patients will likely see additional price increases on prescription drugs in the years to come.” 

"Making sure drugmakers are playing by the rules is critical to lowering the price of prescription medications. This bill will curb anti-competitive, pay-for-delay tactics that artificially inflate prices for patients and prevent access to more affordable alternatives,” said Grassley. “Senators Ernst and Leahy have a long history of supporting patient access to affordable medications and I'm happy to welcome them in this commonsense, bipartisan effort."

Last Congress, Leahy introduced, and Grassley and Klobuchar cosponsored, the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, which would address abuses and delay tactics that prevent generic companies from performing the necessary testing and distribution necessary for U.S. Food and Drug Administration (FDA) approval. The CREATES Act passed the Senate Judiciary Committee on June 14, 2018 on a strong, bipartisan vote of 15 to 6.  The Congressional Budget Office (CBO) has estimated that the bill would result in almost $4 billion in savings.

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