A pair of U.S. senators are renewing efforts to crack down on pay-for-delay pharmaceutical deals, reintroducing the Preserve Access to Affordable Generics Act Wednesday.
Sen. Amy Klobuchar (D-Minn.), and Sen. Chuck Grassley (R-Iowa), say the bill will put an end to the practice by brandname drugmakers of making payoffs to generic manufacturers to keep cheaper alternatives from coming to market.
The lawmakers point to an FTC report from December 2014 that identified 29 potential pay-for-delay settlements involving 21 branded drugs with a combined U.S. sale of about $4.3 billion. They say pay-for-delay agreements can delay generic entry into the market by nearly 17 months.
The legislation would make it illegal for drugmakers to use anticompetitive pay-offs to keep generics off the market, and is similar to a bipartisan bill they introduced with other legislators in 2013 that did not clear committee (DID, Jul 23, 2013). The legislation goes beyond restrictions outlined in the Supreme Court decision in FTC v. Actavis by classifying all pay-for-delay deals as presumptively illegal, but allowing drugmakers to prove their deal isn't anticompetitive.
Klobuchar's office said the bill, which hasn't been assigned a number, is expected to go to the Judiciary Committee.