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Specialists attack drug agency’s fast track approval scheme

BMJ 2016; 353 doi: (Published 01 June 2016) Cite this as: BMJ 2016;353:i3060
  1. Nigel Hawkes
  1. London

A plan to fast track the approval of new medicines in Europe has been criticised by a group of leading specialists in pharmacology and public health.

They argued in a letter to top officials at the European Medicines Agency (EMA) that the “adaptive pathways” pilot, which aims to speed the adoption of new drugs and reduce their cost, is based on flawed assumptions that lack a proper evidence base.

Among the signatories were Martin McKee, of the London School of Hygiene and Tropical Medicine; Peter Gøtzsche, of the Nordic Cochrane Centre in Copenhagen, Denmark; Tom Jefferson, honorary fellow at the Centre for Evidence-Based Medicine at Oxford; and Richard Thompson, past president of the Royal College of Physicians.

The EMA’s plan was also attacked by the European Public Health Alliance, a European non-governmental organisation, in …

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