Medicare Formularies Are Inconsistent in their Response to FDA Black Box Warnings

Sanket Dhruva

Robert Wood Johnson Foundation Clinical Scholars Program, Yale School of Medicine

Sanket Dhruva, MD is a cardiologist and Robert Wood Johnson Foundation Clinical Scholar at Yale University School of Medicine. He graduated from UCSF School of Medicine as an Alpha Omega Alpha awardee in 2009 and stayed at UCSF for internal medicine residency. He then completed cardiology fellowship at UC Davis in Sacramento, California where he was twice fellow of the year in the Department of Internal Medicine. Dr. Dhruva has studied the FDA’s premarket regulation of medical devices and defined the strength of evidence for device approval. He has also identified differences in the safety and effectiveness of devices in women. Dr. Dhruva also studies Medicare formulary coverage, seeking to understand how Medicare can provide coverage of safer, more effective, and more cost-effective medications. He is interested in developing and assessing the evidence base for novel medical products and ensuring that medical interventions have an acceptable risk/benefit profile. He also collaborates on an annual literature update on medical overuse.

Abstract

Introduction: The US Food & Drug Administration (FDA) issues black box warnings for drugs with serious safety risks. The impact of black box warnings on formulary coverage is unknown. Methods: We identified all FDA-approved... [ view full abstract ]

Authors

  1. Sanket Dhruva (Robert Wood Johnson Foundation Clinical Scholars Program, Yale School of Medicine)
  2. Pinar Karaca-mandic (University of Minnesota)
  3. Nilay Shah (Mayo Clinic)
  4. Daniel Shaw (Yale University School of Medicine)
  5. Joseph Ross (Yale University School of Medicine)

Topic Areas

Prevalence and drivers of overuse , Overuse in the care of the elderly and at end of life

Session

AS-1B » Abstract Slams: Education & Policy (12:00 - Friday, 5th May, Salons 6, 7, & 8)

Presentation Files

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