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FDA must publish data on safety and efficacy of prophylactic AIDS drug, court rules

BMJ 2013; 347 doi: http://dx.doi.org/10.1136/bmj.f5161 (Published 19 August 2013) Cite this as: BMJ 2013;347:f5161
  1. Nigel Hawkes
  1. 1London

A US court has ruled that the Food and Drug Administration should release safety and efficacy records on the pre-exposure prophylactic AIDS drug, the combination of tenofovir and emtricitabine, Truvada, marketed by Gilead Sciences.

The data were sought by the AIDS Healthcare Foundation under freedom of information rules, but the FDA had denied the application on the grounds that releasing the data would compromise Gilead’s commercial position in the market.

Ruling in favour of the foundation on 6 August, US District Court judge Margaret Morrow said the FDA had failed to show that the data fell into the class that would allow this exemption from freedom of information rules to apply. She ordered the FDA to produce “complete and unredacted” copies of …

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