Senators Leahy and Ernst have joined as new cosponsors

The Senate Finance Committee, chaired by Senator Grassley, held a hearing today exploring ways to bring down the skyrocketing prices of prescription drugs

WASHINGTON- U.S. Senators Amy Klobuchar (D-MN) and Chuck Grassley (R-IA), announced that U.S. Senators Patrick Leahy (D-VT) and Joni Ernst (R-IA) have joined their bipartisan legislation 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.

“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."

“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.”

“High drug prices affect all Iowans, especially our seniors and those living on a fixed income. When competition is artificially stifled and affordable alternatives are purposely kept off the market, prices stay high and our seniors and middle-class Americans foot the bill. Our bipartisan legislation will help increase competition and lower drug costs,” said Ernst.

Klobuchar and Grassley have long supported efforts to combat anti-competitive tactics in the pharmaceutical market. The senators were the lead sponsors of the Preserve Access to Affordable Generics Act, which would limit “pay for delay” deals in which brand-name and generic drug manufacturers use anti-competitive pay-off agreements to delay cheaper generic equivalents from reaching consumers. Last Congress, Grassley and Klobuchar also introduced the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, with Senator Leahy, 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 16 to 5.  The Congressional Budget Office (CBO) has estimated that the bill would result in almost $4 billion in savings.

Klobuchar has championed efforts to protect consumers and lower prescription drug costs by promoting competition in the healthcare system, authoring multiple pieces of bipartisan legislation that would address the high cost of prescription drugs. Klobuchar introduced legislation—that has 34 cosponsors—to lift the ban on Medicare negotiating for the best possible price of prescription drugs for nearly 41 million seniors enrolled in Medicare Part D. In 2017, Klobuchar and the late Senator John McCain (R-AZ) introduced the Safe and Affordable Drugs from Canada Act, bipartisan legislation that would allow individuals to safely import prescription drugs from Canada. Klobuchar’s Short on Competition Act, introduced with Senator Mike Lee (R-UT) and cosponsored by Senators Grassley and Dick Durbin (D-IL), would allow the temporary importation of drugs that have been approved in another country with similar safety requirements and face little or no competition in the U.S.

In November 2018, Klobuchar and Senator Chuck Grassley (R-IA), sent a letter to the sent a letter to the President urging him to support legislation to limit anticompetitive “pay-for-delay” pharmaceutical settlements as part of the Administration’s effort to bring down the skyrocketing price of prescription drugs. Full text of the letter can be found here.

In a June 2018 letter, Klobuchar and Grassley urged the Federal Trade Commission (FTC) to examine whether makers of biologic medicines are using strategies like “pay for delay” to hinder or delay biosimilars from entering the market. Full text of the letter can be found here.