Source: United States Senator for New Hampshire Jeanne Shaheen
April 04, 2023
**Legislation increases competition and brings generic drugs to market to lower costs**
(Washington, DC) – U.S. Senators Jeanne Shaheen (D-NH) and Susan Collins (R-ME), co-chairs of the Senate Diabetes Caucus, along with Senators Michael Bennet (D-CO), Marco Rubio (R-FL), Tammy Baldwin (D-WI) and Mike Braun (R-IN) reintroduced the Ensuring Timely Access to Generics Act this week to help lower the cost of prescription drugs. The legislation would increase competition for generic drugs by providing better oversight from the Food and Drug Administration (FDA), which would help to lower costs.
“Sky-rocketing prescription costs is one of the biggest concerns I hear from Granite Staters. That’s why I am renewing my bipartisan push to lower prescription drug prices for New Hampshire families by ensuring competition and bringing more generic drugs to the market,” said Senator Shaheen, co-chair of the Senate Diabetes Caucus. “There is a strong bipartisan desire to find common ground on cutting these soaring costs, so I appreciate Senators Collins, Bennet, Rubio, Baldwin and Braun’s support on this legislation that I believe could help Congress make progress toward that goal.”’
“We know that increasing generic drug competition is key to lowering prescription drug prices for individuals and reducing drug spending overall. On average, generic drugs cost 80 to 85 percent less than their brand-name equivalents,” said Senator Collins. “The bipartisan Ensuring Access to Generics Act would help address barriers that currently delay market entry for generic drugs. If enacted, this bipartisan bill will improve competition and save patients money.”
“While big pharmaceutical companies are turning record profits, too many Wisconsin families are struggling to afford the cost of prescription drugs, forcing some to ration or forgo their medication. It’s not right and I am working to address it in Washington,” said Senator Baldwin. “I am proud to join my Democratic and Republican colleagues to work to lower the cost of prescription drugs by bringing more generic drugs on the market and increasing competition.”
“The rising cost of prescription drugs is a problem countless American families have to confront. Unfortunately, bad actors have been employing anti-competitive tactics to exploit the regulatory process for their own gain,” said Senator Rubio. “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 Inflation Reduction Act was an important first step to lower prescription drug costs for seniors, but lifesaving medicine remains unaffordable for far too many Americans,” said Senator Bennet. “This bill will increase competition and improve options for patients – another crucial step to make high-quality health care more accessible for every American.”
Shaheen’s legislation would work to increase competition from generic drugs through better oversight of the Food and Drug Administration’s (FDA) citizen petition process. The citizen petition process allows interested stakeholders, including drug companies, to bring concerns to the FDA’s attention regarding pending applications. Currently, the process is being exploited by bad actors who fill 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.
Senator Shaheen has led efforts across the aisle to lower health care costs for Granite Staters and Americans. She leads bipartisan efforts in Congress with Senator Collins, as co-chairs of the Senate Diabetes Caucus, 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. The pair also lead the Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act, a bipartisan proposal that institutes measures to encourage insulin manufacturers to reduce list prices, while extending patient protections that will foster competition and broader access to desperately needed insulin products. 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. Shaheen previously 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.
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