Shaheen, Gardner, Cassidy & Bennet Introduce Bipartisan Bill to Lower Prescription Drug Prices

April 12, 2019

(Washington, DC) – Yesterday, U.S. Senators Jeanne Shaheen (D-NH), Cory Gardner (R-CO), Bill Cassidy (R-LA) and Michael Bennet (D-CO) introduced the Ensuring Timely Access to Generics Act of 2019, bipartisan legislation aimed at lowering prescription drug prices by increasing competition through improved oversight of the Food and Drug Administration’s (FDA) citizen petition process.

The citizen petition process allows interested stakeholders, including drug companies, to bring concerns to the FDA’s attention regarding pending applications. Currently, bad actors have discovered how to exploit this process by filing citizen petitions in order to delay the approval of generic competitors and extend their patent protections. This legislation ensures FDA’s ability to reject citizen petitions if they believe that the primary purpose of the petition is to delay the approval of an application, thereby increasing competition in the marketplace and lowering costs for patients. 

The Senators’ bipartisan legislation takes the additional step of requiring the Secretary of Health and Human Services (HHS) to establish procedures for referring a petitioner to the Federal Trade Commission (FTC) if they have reason to believe a petition was submitted with the primary purposes of delaying the approval of another application.  

“We must prioritize bipartisan solutions to lower health care costs for American families, and confronting skyrocketing prescription drug prices is fundamental to this goal,” said Senator Shaheen. “This common-sense legislation would remove obstacles that block generic prescription medications from entering the market, and would help reduce costs for patients. I appreciate Senators Gardner, Cassidy and Bennet’s partnership in pushing this bill forward and I’ll continue to work beside them to garner more bipartisan support in Congress so we can deliver necessary relief to Granite State families and millions more throughout the country.”

“I hear frequently from families in Colorado, and across the nation, who are suffering from the rising cost of prescription drugs, including life-saving medications like insulin and opioid addiction treatment. This bipartisan legislation would lower the cost of care by removing obstacles to increase competition and prevent brand name drug companies from gaming the system,” said Senator Gardner. “While this legislation is just one step toward lowering prescription drug costs for families, it’s critical we stop bad actors that threaten access to affordable drugs. Addressing this issue will require a multi-faceted, bipartisan approach, and I will continue to work alongside my colleagues to help alleviate the financial burden of prescription drug costs.”  

“To lower the cost of drugs we need to increase competition,” said Dr. Cassidy. “Getting generics to market faster increases access and saves money for patients and taxpayers.” 

“The high cost of prescription drugs in our country is outrageous. And the fact that the citizen petition process can be exploited by bad actors, preventing Americans from accessing more affordable drugs, is unacceptable,” said Senator Bennet. “We need to remedy flaws in our drug approval process to increase opportunities for affordable, generic drugs to enter the market. I look forward to continue working with my colleagues on both sides of the aisle to increase competition and drive down the cost of prescription drugs.”  

Senator Shaheen is leading efforts in the Senate to reduce the cost of prescription drugs. She introduced the Biologic Transparency Act of 2019, bipartisan legislation to encourage competition in the prescription drug marketplace and put an end to the harmful patent strategies that block new drugs from coming to market. She also introduced the End Taxpayer Subsidies for Drugs Ads Act of 2019 to eliminate tax deductions that pharmaceutical companies use to pay for drug advertising, which ultimately allows companies to increase their drug prices. Shaheen’s bill would ensure taxpayer dollars are not used to subsidize drug advertisements.

Senator Shaheen has also led efforts in the Senate to stabilize the health insurance markets and make health care affordable and accessible for all Americans. Earlier this month, Senator Shaheen led all 47 Senate Democrats on a Senate resolution urging the Department of Justice (DOJ) to reverse its recent position to side with U.S. District Court Judge Reed O’Connor’s ruling that deems health care protections enjoyed by millions of Americans unconstitutional.

Shaheen’s resolution came on the heels of her new health care affordability package. Shaheen’s health care affordability package includes three pieces of legislation that would reduce health care costs for patients and expand access to critical medical services. Together, the Marketplace Certainty ActImproving Health Insurance Affordability Act and Reducing Costs for Out-of-Network Services Act would make essential reforms to the health care law that would help stabilize the marketplace, lower premiums for middle-class families and combat escalating out-of-pocket health care costs. Shaheen has also sponsored legislation this Congress that would counteract the Trump administration’s sabotage efforts that slashed health care enrollment advertising by 90 percent since the President took office, as well as legislation that would prevent the administration from using federal premium tax credits to promote and incentivize enrollment in “junk plans” that do not provide coverage of pre-existing conditions or essential health benefits.

Bill text of the Ensuring Timely Access to Generics Act of 2019 can be found here