(Accessed 12 May 2018)
The next forum for unraveling FDA off-label marketing rules: State and federal legislatures
Michael S. Sinha, Aaron S. Kesselheim
Editorial | published 08 May 2018 PLOS Medicine
…Buoyed by a narrow victory in one appeals court, advocates have turned to state and federal legislatures to unravel current FDA rules relating to off-label promotion. But these rules are essential for the ability of the FDA to fulfill its public health mission by defining what uses of drugs have benefits that outweigh their risks versus those that lack sufficient evidence to warrant such use. These distinctions are crucial for individual physicians—who do not have the time or expertise to perform the same critical data evaluation conducted by the scores of highly trained scientists at the FDA—and for patients, who could be exposed to more non–evidence-based and potentially dangerous off-label uses of high-cost drugs.