Innovation Saves Lives: Evaluating Medicare Coverage Pathways for Innovative Drugs, Medical Devices, and Technology

As one of the most entrepreneurial countries in the world, we have made a choice to invest in the development of lifesaving and life-changing technologies. Since 1950, the U.S. Food & Drug Administration (FDA) has approved over 1,200 new molecular entities (NME), and in 2022 alone the FDA approved 22 NMEs and 15 new biologic drugs, echoing a historical trend. The medical device industry offers a similar story, with the FDA approving 22 new premarket approval (PMA) applications and 3,194 510(k) clearances in 2022. New paradigms continue to emerge, with the FDA having approved over 521 artificial intelligence/machine learning (AI/ML) devices as of the date of this hearing.

This is not just a story of numbers, as innovation has resulted in meaningful improvements for both individual patients and populations. Life sciences innovation has driven changes in care delivery, with cardiovascular disease being a prime example. Innovation in surgical techniques and tools resulted in coronary artery bypass graft surgery becoming the standard of care for advanced cardiovascular disease. Subsequent innovation resulted in the rise of interventional cardiology and stenting, transforming a previously highly morbid surgical procedure into a far less morbid procedure. Pharmaceutical product innovation followed lockstep, with the development of new anti-platelet agents to prevent cardiac in-stent thrombosis, statins to lower cholesterol, improved blood pressure medications such as angiotensin
receptor blockers, and recently the development of fixed-dose, combination products such as sacubitril/valsartan to treat advanced heart failure.

Read the full testimony here.