FDA should tighten post-marketing surveillance of prescription drugs, says Institute of Medicine

BMJ 2012; 344 doi: (Published 01 May 2012) Cite this as: BMJ 2012;344:e3104
  1. Bob Roehr
  1. 1Washington, DC

The US Food and Drug Administration (FDA) should look at the risk-benefit profile of approved drugs at pre-specified times after they are put on the market, the Institute of Medicine has recommended.

Its two year study, published on 1 May, grew out of a series of high profile controversies over drugs such as rosiglitazone for diabetes, rofecoxib for pain relief, and the cholesterol lowering drug rosuvastatin. It centres on enhanced regulatory authority given to the FDA in 2007 when Congress changed the law governing the agency.

Drug …

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