Shaheen, Cassidy Bill to Reduce Prescription Drug Prices Clears Senate HELP Committee

June 17, 2022

(Washington, DC) – A bipartisan bill introduced by U.S. Senators Jeanne Shaheen (D-NH) and Bill Cassidy (R-LA) to lower the cost of prescription drugs cleared a key committee hurdle this week. The Ensuring Timely Access to Generics Act of 2021 would tackle exorbitant prescription costs by increasing competition from generic drugs through better oversight of the Food and Drug Administration’s (FDA) citizen petition process. Helping families afford life-saving prescriptions is crucial to help those at-risk, including those with pre-existing conditions, stay healthy during the pandemic. 

The legislation passed the Senate Committee on Health, Education, Labor and Pensions (HELP) as part of the FDA user fee package agreement.  

“Sky-rocketing prescription costs are one of the top concerns I hear from Granite Staters. That’s why I am glad to see my bipartisan bill to make prescription drugs more affordable one step closer to becoming law. Ensuring competition and bringing more generic drugs to the market will help drive down prices for life-saving medications,” said Shaheen. “I’m committed to working across the aisle to help families afford the prescriptions they need, and I’m glad to see the bipartisan momentum behind this bill. Essential medical care should never be out of reach for patients.” 

“Increasing competition lowers drug costs and improves access for patients,” said Dr. Cassidy. “Glad to see we are continuing to remove barriers that delay market entry for generic 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 the FDA has the 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 bill would also set a time limit to ensure that citizen petitions are submitted in a timely manner after the petitioning party becomes aware of the information upon which their petition is based. This time limit helps avoid instances where brand name drug manufacturers slow down the FDA review process by filing citizen petitions shortly before a generic drug is set to be reviewed by FDA. 

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.  

Full text of the bill is available here

Senator Shaheen has led efforts across the aisle to lower health care costs for Granite Staters and Americans. She is currently leading a bipartisan framework with Senator Collins (R-ME) to reduce the cost of insulin. Shaheen has led legislation to roll back more than a decade of insulin prices hikes, and she has consistently held insulin manufacturers, insurers and pharmacy benefit managers accountable for the skyrocketing cost of life-saving insulin. She also reintroduced bipartisan legislation to lower the cost of health care by allowing individuals to import safe prescription drugs from Canada. In addition, Shaheen introduced bipartisan legislation to close the orphan drug loophole that drug companies use to keep cheaper, generic medication off the market and to rake in profits. She also advocated for legislation that would allow for Medicare to negotiate drug prices on behalf of seniors. Shaheen 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 reintroduced the End Taxpayer Subsidies for Drugs Ads Act to eliminate tax deductions that pharmaceutical companies use to pay for drug advertising, which ultimately increases consumer demand and gives companies leverage to increase their drug prices.