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Washington, D.C. — U.S. Senators Marco Rubio (R-FL), Jeanne Shaheen (D-NH), Bill Cassidy (R-LA), and Michael Bennet (D-CO) introduced legislation to lower prescription drug prices. The Ensuring Timely Access to Generics Act of 2021 would tackle exorbitant prescription costs by increasing competition for generic drugs through better oversight of the Food and Drug Administration’s (FDA) citizen petition process. 

“The rising cost of prescription drugs is a problem facing countless American families. Unfortunately, bad actors have been employing anti-competitive tactics to exploit the regulatory process for their own gain,” Rubio said. “Like any other industry, the pharmaceutical market needs competition to keep drug prices fair. This legislation would lower costs by preventing brand-name drug companies from abusing the FDA pharmaceutical approval process to delay generic drugs from entering the market.”

“The COVID-19 pandemic further exposed the need to improve access to life-saving medications, which help many at-risk Americans stay healthy during this precarious time. Now more than ever, cost should never be a barrier to medical care, including medication,” Shaheen said. “I’m glad to lead this bipartisan effort to help ease the financial strain felt by so many families by bringing more generic drugs to the market, increasing competition and driving down costs. Health care is one of the top issues I hear from Granite Staters, and I’ll continue partnering with Senators across the aisle on common-sense ways to put quality health care within reach for our families.”

“Increasing competition lowers the cost of drugs,” Cassidy said. “Driving generics to market faster improves access and saves money for patients and taxpayers.”

“No American should be forced to choose between their medications and paying their bills, but many find themselves facing difficult decisions because of the skyrocketing cost of prescription drugs in this country,” Bennet said. “The Ensuring Access to Generics Act would remedy flaws in our drug approval process to increase opportunities for affordable, generic drugs to enter the market, and I look forward to working with my colleagues on both sides of the aisle to move this bill forward and drive down the cost of prescription drugs.”

Background:

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’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 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 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.