Congressmen Don Davis & August Pfluger Introduce Legislation to Improve Access to Lifesaving Medications
WASHINGTON, D.C. — U.S. Representative Don Davis (NC-01) and U.S. Representative August Pfluger (TX-11) introduced the bipartisan H.R. 2542, the Old Drugs, New Cures Act, legislation to improve access to innovative, affordable medication and tackle health disparities in rural and low-income communities across America.
"To ensure every patient, no matter their income, no matter where they live, has access to the best treatments possible, Congress must pass legislation to encourage the development of new, affordable drugs,” said Congressman Don Davis. “Eastern North Carolina communities face the greatest health care disparities of any region in the state. Without an incentive for innovation, patients will not have access to affordable, quality health care."
Current Medicaid regulations inhibit the research of certain conditions that disproportionately affect rural and low-income communities, like sickle cell disease or other chronic illnesses. The Old Drugs, New Cures Act would carve out an exemption for “priority research” drugs in existing law, allowing for a smoother path from drug development to patient access. To ensure equal access to lifesaving cures, a drug designated as a “priority research drug,” would be excluded from the definition of a “line extension,” therefore making it more accessible to all patients and encouraging innovation at the same time.
“The federal government should be fostering medical innovation, not standing in its way," said Congressman August Pfluger. "Unfortunately, current HHS regulations create unnecessary barriers to researching new applications for existing medications, preventing potentially life-changing treatments from reaching the patients who need them most. I'm proud to join Congressman Don Davis once again in introducing the Old Drugs, New Cures Act, which will clear these obstacles and create a smoother pathway for breakthrough treatments to reach the market, particularly for conditions that disproportionately affect rural and underserved communities.”
“As a global diversified pharmaceutical company enriching lives through a relentless drive to deliver better health outcomes, new legislation allowing manufacturers the ability to study and bring forward new treatments based on existing FDA-approved products just makes sense for patients,” said Jeff Hartness, Executive Vice President, Market Access, Commercial Operations, Neurology, Generics and Government Affairs. “We believe the introduction of the Old Drugs New Cures Act legislation has the potential to positively impact patient lives in a way that otherwise will not be feasible.”
“Here at Bausch Health, we are focused on our core R&D platforms, but we are also continuously looking across our existing portfolio to identify underserved, unmet diseases and therapeutic areas,” said Dr. Tage Ramakrishna, M.D., Chief Medical Officer, President, R&D at Bausch Health. As knowledge of disease states and pharmaceutical products increase, manufacturers like Bausch Health need the ability to study all molecules, new and old, for future medical breakthroughs.”
“Reformulating existing drugs is an opportunity for innovation to address unmet needs in an efficient and timely manner,” said Donna R. Cryer, JD, founder and CEO of Global Liver Institute. “New uses for existing drugs have long been supported by the rare disease community, for whom treatment options are highly limited. This bill presents an opportunity to advance health equity by driving innovation to Medicaid-eligible patients who experience high unmet medical needs.”
“GLI strongly supports innovation that addresses unmet needs in an efficient and timely manner,” said Larry Holden, CEO of Global Liver Institute.“Only about 5% of rare disease patients have a treatment approved by the FDA, making any policy to incentivize new uses for existing drugs especially valuable for vulnerable populations, particularly patients whose care is largely provided by Medicaid.”