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Verify, Then Trust: How To Legalize Off-Label Drug Marketing, Fazal Khan, Justin Holloway
Verify, Then Trust: How To Legalize Off-Label Drug Marketing, Fazal Khan, Justin Holloway
Fazal Khan
This article proposes a novel framework for more broadly securing the benefits of “off-label” drug usage while mitigating the harms inherent to this practice. Once the FDA approves a drug, doctors can prescribe for it any indication they think is reasonable, even uses that have not been thoroughly tested. The FDA bans the marketing or promotion for off-label uses by drug companies precisely because such uses have not been validated to be safe or effective through the regulatory process. Further, there are serious concerns with validity of industry-sponsored off-label research related to practices such as ghostwriting, gag-clauses on researchers, and …
Is There An Efficient Antitrust Approach To Health Care?, Kathryn Ciano
Is There An Efficient Antitrust Approach To Health Care?, Kathryn Ciano
Kathryn Ciano
As American states and the federal government wrestle to find a solution to health care reform, some regulators are looking towards antitrust laws in the international marketplace to govern domestic health care policy. Antitrust principles dictate that antitrust authorities must intervene only when pressures become so great as to interfere with the very operations of the market. Pharmaceutical and health care markets rely on free trade and competitive global cooperation, so there is no efficient antitrust approach to health care.