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US consumer group criticizes proposal to allow drug makers to challenge safety information

BMJ 2015; 350 doi: (Published 17 March 2015) Cite this as: BMJ 2015;350:h1514
  1. Michael McCarthy
  1. 1Seattle

A proposal by the US Food and Drug Administration to allow drug companies to distribute peer reviewed articles indicating that FDA approved labeling overstates a drug’s risks drew near unanimous opposition during its public comment period, shows an analysis of the comments obtained under a Freedom of Information Act request.

In June 2014 the FDA posted for public comment a draft guidance letter that, if adopted, would allow drug companies to distribute “new risk information that rebuts, mitigates, or refines risk information in approved labeling” if the information came from studies that were “sufficiently well designed and informative to merit consideration in assessing the implications of a risk” and were published in an independent, peer reviewed journal.1

Pre-market studies, the FDA argued in the proposed guidance document, evaluate a drug’s effectiveness by considering trials that are designed to determine whether the drug is effective …

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