Supported by Local Pharmaceutical Manufacturers
By Hank Russell
U.S. Representative Andrew Garbarino (R-Patchogue) reintroduced a bill cosponsored by Tom Suozzi (D-Glen Cove) that they said 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.
The Ensuring Access to Essential Drugs Act, which is also cosponsored by Diana Harshbarger (R-Tennessee), 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 was approved under a new drug application (NDA) pursuant to the U.S. Food and Drug Administration’s (FDA) 1997 Federal Register Notice and has been granted a “narrow exception” by CMS under the Medicaid Drug Rebate Program (MDRP).
“This legislation puts patients first by ensuring the affordability and accessibility of widely used medications,” Garbarino said. “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.”
“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,” Suozzi said. “Hypertechnical language will hurt this company and these patients and they need a fair exception under Medicare. Let’s get it done.”
“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,” said Harshbarger, who is also a pharmacist.
Jerome Stevens Pharmaceuticals (JSP), a small, family-owned American company of nearly 50 years based in Bohemia, 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.
“[This bill] will also help ensure a reliable, high-quality domestic supply for what is one of the most commonly prescribed chronic disease therapies for Americans,” aid Chirag Patel and Chintu Patel, Co-CEOs of Amneal Pharmaceuticals, which has locations in Brookhaven, Hauppauge and Yaphank. “Regulatory technicalities should never stand in the way of patient care. For many, this medication is not just important—it’s a lifeline.”