David A. Hyman

David A. Hyman, MD, JD

Scott K Ginsburg Professor of Health Law & Policy, Georgetown University Law Center

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FreeGuest Editorial

By law, the Food and Drug Administration is required to determine whether a drug, device, biologic, or medical device is “safe and effective.” But the FDA determination does not control whether the Centers for Medicare & Medicaid Services will pay for it.  To satisfy CMS, medical products and services must be “reasonable and necessary,” meaning...

ClinicalTrials & Tribulations
There is general agreement that the United States spends too much on health care, especially on pharmaceuticals.  But what we spend on drugs is not simply a function of price. If eggs double in price, people can simply cut the number of eggs they eat in half.  Simply stated, cost is the product of (price per unit times the number of units purchased). 

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