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Approving a Problematic Muscular Dystrophy Drug: Implications for FDA Policy

Posted in Publications on 12.20.2016

JAMA. 2016;316(22)2257-2258 In September 2016, the head of the FDA’s Center for Drug Evaluation and Research approved a new drug (etiplersen) for the treatment of Duchenne muscular dystrophy, despite an advisory committee who voted 7 to 3 finding no evidence that the drug had clinical ef...


The High Cost of Prescription Drugs in the United States: Origins and Prospects for Reform

Posted in Publications on 9.6.2016

JAMA. 2016;316(8)858-871 High prescription drug prices are increasingly straining the budgets of patients, payors and healthcare systems in the United States. In this JAMA clinical review, Drs. Avorn, Kesselheim and Sarpartwari describe the origins for high drug prices and recommend policy options ...


Forbidden and Permitted Statements about Medications – Loosening the Rules

Posted in Publications on 9.10.2015

NEJM. 2015;373(10)967-973 The promotion of drugs by manufacturers for uses not previously approved by the FDA (aka off-label use) is controversial because it may lead to more patients being exposed to medicines with an uncertain risk-benefit profile. In an article published in the New England Journ...