Intended for healthcare professionals


Personalised medicine requires regulatory change, former FDA head says

BMJ 2008; 336 doi: (Published 26 June 2008) Cite this as: BMJ 2008;336:1461
  1. Bob Roehr
  1. 1Washington, DC

Regulatory changes are needed in the way that drugs are developed, approved, and paid for so that the potential of genetic and molecular personalised medicine can be realised, a former head of the US Food and Drug Administration said at a forum in Washington, DC, last week.

“The goal is a more solid model of disease progression and a more solid understanding of when treatments are having an impact on particular patients,” said Mark McClellan, the commissioner of the FDA from 2002 to 2004 and later head of the Medicare system. Under legislative changes passed last year the FDA is moving towards a …

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