In a letter to FTC Chairwoman Edith Ramirez, the senators urged the FTC to aggressively challenge any anticompetitive settlements where brand-name drug companies pay generic drug companies to delay marketing lower cost generic drugs

Klobuchar and Grassley have introduced bipartisan legislation that would help put an end to these pay-off agreements, bring more affordable generic equivalents on the market, and ensure consumers have access to cost-saving generic drugs they need

WASHINGTON, DC – U.S. Senators Amy Klobuchar (D-MN) and Chuck Grassley (R-IA) today called on the Federal Trade Commission (FTC) to protect consumers from anticompetitive pay-for-delay patent settlements. In a letter to FTC Chairwoman Edith Ramirez, the senators urged the FTC to aggressively challenge any anticompetitive settlements where brand-name drug companies pay generic drug companies to delay marketing lower cost generic drugs. Klobuchar and Grassley have introduced the Preserve Access to Affordable Generics Act to help put an end to these pay-off agreements, bring more affordable generic equivalents on the market, and ensure consumers have access to the cost-saving generic drugs they need.

“We are writing to encourage the Federal Trade Commission to maintain its vigilance in protecting American consumers from anticompetitive pay-for-delay patent settlements, which keep more affordable generic equivalents off the market,” the senators wrote. “This issue is extremely important to consumers; competitive drug prices are necessary for affordable health care. We commend the FTC for its work in this area but encourage you to aggressively challenge any pharmaceutical patent settlement that is anticompetitive.”

Klobuchar and Grassley have long supported efforts to combat anti-consumer pay-for-delay settlements. The senators are the lead sponsors of the Preserve Access to Affordable Generics Act, which would crack down on anti-competitive pay-offs and make sure consumers have access to cost-saving generic drugs they need. The bipartisan legislation would make it illegal for brand-name drug manufacturers to use anti-competitive pay-off agreements to keep more affordable generic equivalents off the market. Klobuchar and Grassley introduced similar legislation in 2010 following a resurgence of patent settlement agreements. In July 2013, the Judiciary Committee Subcommittee on Antitrust, Competition Policy, and Consumer Rights held a hearing to scrutinize pay-for-delay deals.

Full text of the letter is below:

Dear Chairwoman Ramirez:                                                                                      

We are writing to encourage the Federal Trade Commission to maintain its vigilance in protecting American consumers from anticompetitive pay-for-delay patent settlements, which keep more affordable generic equivalents off the market. The FTC should be proud of its work in this area.

Unfortunately, neither the Supreme Court’s decision in Federal Trade Commission v. Actavis nor the earlier Third Circuit decision In re K-Dur Antitrust Litigation appears to have stopped this practice. You reported 29 settlements in 2013 that potentially involved pay-for-delay provisions, impacting $4.3 billion in U.S. sales. Combined with deals from prior years, dozens of agreements may be delaying access to generic drugs, which can be as much as 90 percent cheaper than their brand-name counterparts. As you have documented, agreements with payments to the generic company delay its entry into the market an average of nearly 17 months longer than agreements without payments.

However, in the two years since Federal Trade Commission v. Actavis, the FTC has challenged only one pay-for-delay pharmaceutical patent settlement. Although we appreciate the important work the FTC has done in filing amicus briefs on these issues, enforcing the law in this area is critical to protecting consumers.

We understand the challenges that the FTC still faces in stopping this practice, which is why we have introduced the Preserve Access to Affordable Generics Act. This bill would require pharmaceutical companies to justify any pay-off and impose penalties on companies that break the law. Given the substantial incentives for companies to enter these pay-for-delay agreements, the Preserve Access to Affordable Generics Act would provide the appropriate legal standard and deterrence to protect competition and American consumers.

This issue is extremely important to consumers; competitive drug prices are necessary for affordable health care. Again we commend the FTC for its work in this area but encourage you to aggressively challenge any pharmaceutical patent settlement that is anticompetitive. 

            Thank you for your attention to this matter.

                       

                                                                        Sincerely,