By Jeffrey May, J.D.
Senators Patrick Leahy (D., Vt.) and Joni Ernst (R., Iowa) joined Amy Klobuchar (D., Minn.) and Chuck Grassley (R., Iowa) as co-sponsors of proposed pay-for-delay legislation.
Senate lawmakers are continuing efforts to pass legislation that prohibits anticompetitive pay-for-delay agreements between companies in the pharmaceutical sector. In the last Congress, Sen. Amy Klobuchar (D., Minn.) introduced the Preserve Access to Affordable Generics Act. Despite support from Sen. Chuck Grassley (R., Iowa), then chairman of the Senate Judiciary Committee, that measure failed to pass. That bill would have amended the FTC Act to 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.
Klobuchar and Grassley have now proposed legislation that would go a step further than the prior bill. The proposed Preserve Access to Affordable Generics and Biosimilars Act (S. 64) would cover pay-for-delay deals affecting biosimilar and interchangeable biologics. The bill was introduced on January 9.
Yesterday, Sen. Patrick Leahy (D., Vt.) announced that he joined the bipartisan legislation "to bring down the skyrocketing prices of prescription drugs." Sen. Joni Ernst, Grassley's fellow Republican from Iowa, also lent her support.
"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 in response. "Without competition, U.S. patients will likely see additional price increases on prescription drugs in the years to come."
"Making sure drug makers 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," added 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."
FTC investigation. The senators have also been encouraging the FTC to continue its activity in this area. In June 2018 letter, Klobuchar and Grassley urged the FTC Chairman Joe Simons to examine whether makers of biologic medicines are using strategies like "pay for delay" to hinder or delay biosimilars from entering the market. "Biologics play an important role in treating many serious illnesses and are among the fastest growing classes of therapeutic products … Without biosimilar competition, U.S. patients and payers will likely see additional price increases on biologics in the years to come," wrote the senators. "In light of the importance of biosimilar competition to drive down prices and improve the quality of life for American patients, we urge the FTC to examine global patent settlements relating to biosimilars to ensure they are not in violation of antitrust laws."
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