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The Innovation Imperative: Crossing the Valley of Death
Millions of Americans face diseases that lack treatment options, while many more face impairments in independence as a result of inadequately treated medical conditions. Innovation in the life sciences offers the opportunity to cure debilitating illnesses as well as to promote independence and increased convenience of care delivery. However, pharmaceutical and medical device innovation each face a combination of scientific, engineering, clinical, and subsequent regulatory risks prior to entry into clinical practice.
Regulatory risk lies within the core Food and Drug Administration (FDA) review approval and the Centers for Medicare and Medicaid Services’ (CMS) technology assessment and coverage analysis processes, the latter a requirement for innovators to receive Medicare payment. The FDA and CMS have different missions and, consequently, differing standards which has created an economically disastrous regulatory gap between FDA approval and CMS coverage determination forebodingly called the “Valley of Death.”
Critics have raised concerns about attempts to realign these disparate regulatory processes, often describing them either as lowering the evidentiary standard or as corporate handouts. An alternate approach of separate but coordinated regulatory reforms presents a viable path to both expand access to and decrease the cost of innovation. In turn, driving revolutionary product innovation to disrupt existing care delivery paradigms would lower costs, transform care delivery, and expand access to care. Dr. Brian J. Miller, a practicing physician at Johns Hopkins and policy analyst at the American Enterprise Institute, and Dr. Ted Cho of the University of California, San Francisco (UCSF) lay out a series of reforms.
Regulatory risk lies within the core Food and Drug Administration (FDA) review approval and the Centers for Medicare and Medicaid Services’ (CMS) technology assessment and coverage analysis processes, the latter a requirement for innovators to receive Medicare payment. The FDA and CMS have different missions and, consequently, differing standards which has created an economically disastrous regulatory gap between FDA approval and CMS coverage determination forebodingly called the “Valley of Death.”
Critics have raised concerns about attempts to realign these disparate regulatory processes, often describing them either as lowering the evidentiary standard or as corporate handouts. An alternate approach of separate but coordinated regulatory reforms presents a viable path to both expand access to and decrease the cost of innovation. In turn, driving revolutionary product innovation to disrupt existing care delivery paradigms would lower costs, transform care delivery, and expand access to care. Dr. Brian J. Miller, a practicing physician at Johns Hopkins and policy analyst at the American Enterprise Institute, and Dr. Ted Cho of the University of California, San Francisco (UCSF) lay out a series of reforms.
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