Garbarino, Suozzi, Harshbarger Introduce Ensuring Access to Essential Drugs Act

WASHINGTON, D.C. - Congressman Andrew R. Garbarino (R-NY-02), joined by original cosponsors Representatives Tom Suozzi (D-NY-03) and Diana Harshbarger (R-TN-01), today reintroduced the Ensuring Access to Essential Drugs Act. This bipartisan legislation would ensure that essential medications remain accessible and affordable for patients and provide critical relief for small American manufacturers, safeguarding their ability to produce high-quality medications domestically.

"This legislation puts patients first by ensuring the affordability and accessibility of widely used medications," said Rep. Garbarino. "It also reinforces our support for small businesses and American manufacturing, ensuring that U.S. companies remain competitive and resilient in the global market and ensuring that small, family-owned companies like Long Island's Jerome Stevens Pharmaceuticals can continue their vital work."

Specifically, this legislation would amend Title XVIII of the Social Security Act to exempt from the Medicare Part D Manufacturer Discount Program any orally administered medications, like Levothyroxine Sodium, that:

1. Was approved under an NDA pursuant to the FDA's 1997 Federal Register Notice; and
2. Has been granted a "narrow exception" by CMS under the Medicaid Drug Rebate Program (MDRP).

"This bipartisan legislation provides a common sense fix to help a Long Island business provide 19 million American patients with an essential drug they need," said Rep. Suozzi. "Hyper technical language will hurt this company and these patients and they need a fair exception under Medicare. Let's get it done."

"As a lifelong pharmacist, I am dedicated to ensuring that Americans always have affordable access to the life-saving medications that they need," said Rep. Harshbarger. "This bill addresses a critical oversight in the Inflation Reduction Act to help ensure that levothyroxine sodium-one of the most widely prescribed drugs in the United States and the only FDA-approved treatment for hypothyroidism-can continue to be produced domestically and remains accessible to the patients who depend on it. I'm proud to join my colleagues, Reps. Andrew Garbarino and Tom Suozzi, to introduce this important legislation."

Jerome Stevens Pharmaceuticals (JSP), a small, family-owned American company of nearly 50 years based in Bohemia, NY, is one such manufacturer that has found itself unduly burdened by the Medicare Part D Manufacturer Discount Program.

"Jerome Stevens applauds the introduction of legislation that will ensure that the 12 million Americans affected by hypothyroidism continue to have access to domestically manufactured Levothyroxine Sodium Tablets at an affordable price," said Daniel Akeson, Director of Jerome Stevens Pharmaceuticals, Inc.

"At Amneal Pharmaceuticals, we believe that no patient should ever have to worry about access to the life-saving medicines they depend on. This bipartisan legislation is a vital technical fix that will safeguard access for the 19 million American patients who rely on levothyroxine. It will also help ensure a reliable, high-quality domestic supply for what is one of the most commonly prescribed chronic disease therapies for Americans. Regulatory technicalities should never stand in the way of patient care. For many, this medication is not just important-it's a lifeline. I urge Congress to prioritize patients over bureaucracy and pass this common-sense solution to protect those who need it most," said Chirag Patel and Chintu Patel, Co-CEOs of Amneal Pharmaceuticals.

The full text of the bill can be found here.