Bipartisan CREATES Act would counter common delay tactics used by name-brand manufacturers to prevent competition from lower-cost alternatives 

Klobuchar is the Ranking Member of the Subcommittee on Antitrust, Competition Policy and Consumer Rights

WASHINGTON- U.S. Senator Amy Klobuchar (D-MN), Ranking Member of the Subcommittee on Antitrust, Competition Policy and Consumer Rights, joined other leading Judiciary Committee senators to reintroduce bipartisan legislation to combat anticompetitive practices used by some brand-name pharmaceutical and biologic companies to block entry of lower-cost generic and biosimilar 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. The nonpartisan Congressional Budget Office has estimated that the bill would result in a $3.9 billion net decrease in the federal deficit. Savings to consumers and private insurers likely would likely be billions of dollars more.

The CREATES Act is led by Senator Patrick Leahy (D-VT) and cosponsored by Judiciary Committee Senators Chuck Grassley (R-IA) and Mike Lee (R-UT), the Chairman of the Subcommittee on Antitrust, Competition Policy and Consumer Rights.

“No family should ever be forced to decide between filling a prescription or putting food on the table,” Klobuchar said. “This legislation will help end the unfair practices that drive up prescription drug costs and deter pharmaceutical companies from blocking cheaper generic alternatives from entering the marketplace. All Americans should be able to afford the lifesaving medication they need.”

“I hear from Vermonters every day that rising prescription drug prices are a larger strain each year on their tight budgets.  For too long, a few predatory name brand companies have used anticompetitive strategies to delay entry of lower cost generic drugs.  When these companies use unfair practices to keep drug prices artificially high, patients suffer.  Patients, families and government programs shouldn’t have to cope with increased drug costs to help name brand companies’ bottom lines,” Leahy said. “Our bipartisan bill continues to gain momentum.  It is precisely targeted to stop these abuses, and I’m committed to working on behalf of Vermonters in Congress to see that CREATES and other vital efforts to lower prescription drug prices are signed into law.”

“Generic alternatives to brand-name medications provide consumers with greater choice and more affordable prescription drug options, but anti-competitive practices by some brand-name pharmaceutical companies block access to these lower-cost generics. This behavior hurts consumers and costs taxpayers billions,” Grassley said. “The bipartisan CREATES Act respects intellectual property rights and encourages greater competition that will inevitably lower the price of prescription medications for the American patient. It also saves $3.9 billion in taxpayer dollars and likely far more for consumers and private insurers. I look forward to getting this important tool passed so we can improve access to lower-cost generic drugs.”

“If we’re ever going to bring the cost of health-insurance premiums and prescription drugs under control we must reform the Food and Drug Administration’s excessively onerous, time-consuming regulatory process,” Lee said. “The CREATES Act is an essential first step in that process. It is a commonsense, bipartisan measure that will provide real, immediate relief to a serious problem.”

In addition to Senators Leahy, Grassley, Klobuchar and Lee, the bill is cosponsored by Judiciary Committee Ranking Member Feinstein (D-CA) and Senators Baldwin (D-WI), Blumenthal (D-CT), Booker (D-NJ), Brown (D-OH), Collins (R-ME), Cotton (R-AR), Cruz (R-TX), Daines (R-MT), Durbin (D-IL), Ernst (R-IA), Fischer (R-NE), Hassan (D-NH), Kennedy (R-LA), King (I-ME), Menendez (D-NJ), Murkowski (R-AK), Paul (R-KY), Rounds (R-SD), Smith (D-MN), Stabenow (D-MI), Tester (D-MT), Whitehouse (D-RI) and Young (R-IN).

In the House of Representatives, corresponding legislation was recently introduced by Representatives David Cicilline (D-RI) and Jim Sensenbrenner (R-WI), Chairman and Ranking Member, respectively, of the House Judiciary Subcommittee on Antitrust, Commercial, and Administrative Law. They are joined by House Judiciary Committee Chairman Jerrold Nadler (D-NY), Ranking Member Doug Collins (R-GA) and Representatives Peter Welch (D-VT) and David McKinley (R-WV). The legislation is strongly supported by a coalition of groups as diverse as AARP, American College of Physicians, FreedomWorks, Coalition for Affordable Prescription Drugs and many more.

Klobuchar has long championed efforts to bring down the skyrocketing cost of prescription drugs. Klobuchar and Grassley are the lead sponsors of the Preserve Access to Affordable Generics Act and Biosimilars Act, which would limit “pay for delay” deals in which drug manufacturers use anti-competitive pay-off agreements to prevent or delay the introduction of affordable follow-on versions of branded pharmaceuticals, and the Safe and Affordable Drugs from Canada Act, which allow individuals to safely import prescription drugs from Canada. Klobuchar also introduced legislation—that has Senate 33 cosponsors—to lift the ban on Medicare negotiating for the best possible price of prescription drugs for nearly 43 million seniors enrolled in Medicare Part D. Klobuchar and Lee previously introduced the Short on Competition Act to allow the temporary importation of drugs that have been approved in another country with similar safety requirements and face little or no competition in the U.S.