Institute of Medicine urges reforms at FDA.

摘要

Abuse of power, barbaric working conditions, absence of quality control, despair. All are chronicled in The Jungle, Upton Sinclair's expose of the Chicago meat-packing industry, published 100 years ago. The resulting crisis of confidence in food manufacturing led to the modern Food and Drug Administration. Conceived in crisis, the FDA's history has been built on reactive legislation in response to a sequence of disasters. Only after children died from sulfanilamide was safety added to its terms of reference in 1938, with efficacy added as a criterion in 1962 after the thalidomide tragedy. Now the agency is fighting hard to restore credibility in the wake of the poorly monitored and communicated rofecoxib scandal of 2004-Responding to increasing concerns about the FDA's Center for Drug Evaluation and Research (CDER), the FDA and other stakeholders commissioned an independent evaluation from the Institute of Medicine. The committee heard testimony in open meetings, did interviews, commissioned viewpointsfrom industry, and received reviews from an international multidisciplinary panel of experts. The findings and 25 recommendations are detailed in The Future of Drug Safety: Promoting and Protecting the Health of the Public, published on Sept 26.Between carefully worded lines emerges a picture of CDER as an establishment unfit for purpose: a cadre of dedicated professionals struggling in a dysfunctional organisation, where idiosyncratic opaque processes and a lack of leadership obscure goals and stifle scientific debate. The managerial structure combined with low morale, poor retention, and high turnover of staff compound these problems.