Agency’s Drug Competition Action Plan pulls from Senators’ proposal to improve generic drug competition to ensure patient access to affordable medication
Washington, D.C. - U.S. Senators Susan Collins (R-ME), Claire McCaskill (D-MO), Tom Cotton (R-AR), and Al Franken (D-MN) today applauded the Food and Drug Administration’s announcement that it will expedite the review of generic drug applications where competition is limited, a plan that mirrors one that the Senators have proposed in their bipartisan bill, the Making Pharmaceutical Markets More Competitive Act.
“We know that increasing generic drug competition is key to lowering prescription drug prices and improving access for patients,” said Senator Collins. “I am delighted that the FDA’s new policy implements provisions from our bipartisan legislation to increase generic competition, which is great news for American families, particularly our seniors, and follows our longtime advocacy on this issue.”
“Bringing down the cost of healthcare and prescription drugs is an all hands on deck effort,” McCaskill said. “These are bipartisan, commonsense reforms to make lifesaving drugs more affordable and accessible to Missourians and folks across the country, and it’s great news the Food and Drug Administration plans to implement them.”
“The steady rise in prescription drug costs over the last several years has left many Arkansans wondering just how much more they can take. And as health-care premiums rise under Obamacare, there's now even less room in family budgets to spend more on prescription drugs," said Senator Cotton. "Regrettably, the current FDA backlog of new generic-drug applications awaiting approval is only making this problem worse. Expediting the approval process for both the first and the second generic and requiring the FDA to make a decision in a timely fashion will increase competition in the prescription-drug market and help lower costs for Arkansas families.”
“Families and seniors shouldn’t have to break the bank to afford their prescriptions, but sadly, that’s exactly what’s happening right now.” said Senator Franken. “There’s no question that we have to bring down prescription drug prices and make them more affordable for people, and one of the best ways to do that is by increasing access to generic drugs, which are often sold at a fraction of the price of their brand-name competitors and are just as effective. I’m glad to see that the FDA has adopted our bipartisan plan to bring these products to market faster and to improve competition. This is great news for Minnesotans.”
The Senators’ bipartisan legislation takes a number of steps to enhance regulatory certainty for generic drug companies by setting forth a priority review timeline for generic applications, providing enhanced communications with eligible sponsors, improving transparency, and setting clear expectations about facility inspections.
The Senate Committee on Health, Education, Labor and Pensions recently approved the Senators’ Making Pharmaceutical Markets More Competitive Act as part of the Food and Drug Reauthorization Act.
This legislation builds on the only bipartisan investigation into the causes, impacts, and potential solutions to the egregious price spikes for certain drugs, which was led by the Aging Committee last Congress. From the beginning, the investigation strived to understand why companies can make these large price increases and to identify which policies should be considered to counter these disturbing practices.
Earlier this month, Collins and McCaskill wrote to Food and Drug Administration Commissioner Scott Gottlieb to express their encouragement by his recent remarks in support of solutions to help keep prescription drugs affordable and improve patients’ access to medication, echoing the Senators’ bipartisan efforts.