Washington, D.C. – U.S. Senators Michael Bennet (D-CO), Cory Gardner (R-CO), Jeanne Shaheen (D-NH), and Bill Cassidy (R-LA) today introduced bipartisan legislation to lower prescription drug prices by increasing competition through improved oversight of the Food and Drug Administration’s (FDA) citizen petition process.
“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,” Bennet said. “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.”
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.
This legislation takes the additional step of requiring the Secretary 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.
“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,” Gardner said. “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.”
“We must prioritize bipartisan solutions to lower health care costs for American families, and confronting skyrocketing prescription drug prices is fundamental to this goal,” Shaheen said. “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.”
“To lower the cost of drugs we need to increase competition,” Dr. Cassidy said. “Getting generics to market faster increases access and saves money for patients and taxpayers.”