WASHINGTON, D.C. – U.S. Senator Amy Klobuchar and top leaders on the Senate and House Judiciary Committees introduced legislation to combat anticompetitive practices used by some brand-name pharmaceutical and biologic companies to block entry of lower-cost generic drugs.  The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act would deter pharmaceutical companies from blocking cheaper generic alternatives from entering the marketplace. 

“When people get sick, their focus should be on getting well, not on how to pay for their prescriptions,” Klobuchar said. “Our bipartisan legislation would put an end to pharmaceutical company tactics that delay or prevent lower-cost competition while protecting patient safety and saving Americans consumers billions of dollars.” 

Klobuchar is ranking member of the Subcommittee on Antitrust, Competition Policy and Consumer Rights. The bill is sponsored by Senator Patrick Leahy (D-VT) and cosponsored by Judiciary Committee Chairman Chuck Grassley (R-IA), Ranking Member Dianne Feinstein (D-CA), and Antitrust Subcommittee Chairman Mike Lee (R-UT). Representatives David Cicilline (D-RI) and Tom Marino (R-PA), leaders of the House Judiciary Subcommittee on Regulatory Reform, Commercial and Antitrust Law, introduced an identical version of the bill in the House.

The Congressional Budget Office has estimated that the bill would result in a $3.3 billion net decrease in the federal deficit.  Savings to consumers and private insurers likely would be far greater. The legislation is strongly supported by the Association for Accessible Medicines (AAM), consumer groups including AARP, Consumers Union, and Public Citizen; the American College of Physicians; the American Hospital Association; the Campaign for Sustainable Rx Pricing; and America’s Health Insurance Plans (AHIP).

Klobuchar has championed efforts to protect consumers and lower costs by promoting competition in the healthcare system, including authoring multiple pieces of legislation that would address the high cost of prescription drugs. The bipartisan Preserve Access to Affordable Generics Act Klobuchar introduced with Senator Chuck Grassley (R-IA) would crack down on anti-competitive pay-offs in which branded companies pay their generic competitors not to compete as part of a patent settlement. These pay-off settlements (also known as “reverse payments”) delay consumer access to generic drugs, which can be as much as 90 percent cheaper than brand-name drugs. The legislation would stop these anti-competitive pay-off agreements to keep more affordable generic equivalents off the market and make sure consumers have access to the cost saving generics they need. She also introduced the Medicare Prescription Drug Price Negotiation Act, which would allow for Medicare to negotiate the best possible price of prescription drugs. In addition, Klobuchar introduced the Safe and Affordable Drugs from Canada Act with Senator John McCain (R-AZ) that would require the Food and Drug Administration to establish a personal importation program that would allow individuals to import a 90-day supply of prescription drugs from an approved Canadian pharmacy.