WASHINGTON – U.S. Senator Amy Klobuchar (D-MN), Chairwoman of the Senate Judiciary Subcommittee on Competition Policy, Antitrust, and Consumer Rights, and Senator Chuck Grassley (R-IA) reintroduced the Preserving Access to Affordable Generics and Biosimilars Act and the Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics (Stop STALLING) Act to promote competition and reduce drug costs.
“Every American should have access to affordable health care, but anticompetitive practices and excessive consolidation contribute to rising costs that keep essential treatments and medications out of reach for too many. We must take action to put an end to industry practices that undermine competition and delay the approval of more affordable drugs,” said Klobuchar.
“Addressing the rising costs of prescription drugs has continued to be one of my top priorities. During my 99 county meetings, I consistently hear from my constituents across Iowa who are increasingly concerned about the high costs of prescription drugs. Americans shouldn’t be worried about buying their much-needed medications or getting food on the table,” said Grassley. “I’m proud to introduce bipartisan proposals that will help mitigate these costs. While this is just one piece of the puzzle to improve access to affordable medications, it’s a good start.”
The Preserving 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. Pay-for-delay deals – the practice in which drug companies use pay-off agreements to delay the introduction of cheaper substitutes – increase the cost of prescriptions and impose significant costs on our health care system. The legislation covers pay-for-delay deals affecting biosimilar and interchangeable biologics in addition to generic drugs. Senators Dick Durbin (R-IL), Joni Ernst (R-IA), Patrick Leahy (D-VT), Susan Collins (R-ME), Chris Van Hollen (D-MD), and Kevin Cramer (R-ND) are cosponsors of the bill.
The Stop STALLING Act would reduce the incentives for branded pharmaceutical companies to file sham petitions with the Federal Drug Administration (FDA) to interfere with the regulatory approval of generics and biosimilars that would compete with their own products, a tactic that delays patient access to more affordable medications. The bill would give the Federal Trade Commission (FTC) enhanced authority to take action against those who file sham petitions. Senators Richard Blumenthal (D-CT), Joni Ernst (R-IA), and Patrick Leahy (D-VT) are cosponsors of this bill.
As Chairwoman of the Senate Judiciary Subcommittee on Competition Policy, Antitrust, and Consumer Rights, Klobuchar has championed efforts to protect consumers, promote competition, and fight consolidation in several industries.
In February, Klobuchar introduced the Competition and Antitrust Law Enforcement Reform Act – sweeping legislation to reinvigorate America’s antitrust laws and restore competition to American markets. This legislation would give federal enforcers the resources they need to do their jobs, strengthen prohibitions on anticompetitive conduct and mergers, and make additional reforms to improve enforcement.
She has led the fight against anticompetitive conduct in the pharmaceutical industry, sponsoring multiple pieces of legislation, including the bipartisan Preserve Access to Affordable Generics and Biosimilars Act to crack down on anti-competitive pay-offs in which branded companies pay their generic competitors not to compete as part of a patent settlement. Last year, Klobuchar’s Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, which prevents abusive tactics that hinder affordable drugs from entering the market, was passed into law.
Additionally, Klobuchar has called for strong antitrust review and enforcement to protect consumers from mergers that raise prices or harm competition, including Comcast/Time Warner Cable, AT&T/Time Warner Inc., Anheuser-Busch/Miller-Coors, and T-Mobile/Sprint, and consolidation in the agricultural and online travel industries.