WASHINGTON – U.S. Senators Bill Cassidy, M.D. (R-LA) and Jeanne Shaheen (D-NH) released statements following their bill to lower the cost of prescription drugs clearing 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.
“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.”
“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 Senator 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.”
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.