WASHINGTON–U.S. Senator Bill Cassidy, M.D. (R-LA), today introduced a package of three bills focused on reducing drug prices by getting generics to market faster. Cassidy introduced the Reforming Ever-greening and Manipulation that Extends Drug Years (REMEDY) Act with U.S. Senator Dick Durbin (D-IL), the Protecting Access to Biosimilars Act with U.S. Senator Tina Smith (D-MN) and the Ensuring Timely Access to Generics Act with U.S. Senators Corey Gardner (R-CO), Jeanne Shaheen (D-NH) and Michael Bennet (D-CO).
“No matter where I go in Louisiana people are always mentioning the high cost of prescription drugs,” said Dr. Cassidy. “To lower the cost of drugs we need to increase competition. Getting generics to market faster increases access and saves money for patients and taxpayers.
The REMEDY Act removes overbearing legal barriers that delay generic market entry. Under this policy, once the substance patent and all exclusivities expire, generic manufacturers would be allowed to enter the market based on their assessment of the secondary patent validity and the risk of legal action by the brand, removing the incentive to litigate non-innovative patents while maintaining intellectual property protections, as the patent holder can still choose to litigate.
“Americans are facing skyrocketing prescription drug costs in part because brand-name pharma manufacturers have gamed the patent system to extend their monopolies and avoid competition from lower-cost generic drugs. That doesn’t promote innovative research and it’s not serving the best interests of patients,” said Senator Durbin. “The REMEDY Act will increase competition and help reduce drug costs by curbing patent manipulation by brand name drug makers. This common sense bipartisan legislation is overdue, and I hope my colleagues will join Senator Cassidy and me in supporting it.”
The Protecting Access to Biosimilars Act ensures less expensive insulin can come to market sooner by ensuring current insulin brands do not receive new, extended market protections as the FDA begins regulating insulins as biologics.
“High insulin prices are jeopardizing the financial security of Minnesotans and Americans, and forcing some into alarming, and at times fatal, rationing,” said Senator Smith. “For the millions of people in the United States who rely on insulin, the medication is not a choice; it’s a matter of survival. Patients should be able to afford the medication they need to live. Our bipartisan bill would do what’s right—promote competition and make sure lower-cost insulin comes to market sooner rather than later.”
The Ensuring Timely Access to Generics Act enhances the ability of the FDA to combat frivolous citizen petitions, a tool brand manufacturers use to delay generic entry. The bill gives the FDA 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.
“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.”
“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 medication 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.”
“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.”