Healthy Skepticism Library item: 7854

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Horton LR.
Food and Drug Administration
BMJ 2007 Jan 13; 334:55-56
http://www.bmj.com/cgi/content/full/334/7584/55?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=Food+and+Drug+Administration+&searchid=1&FIRSTINDEX=0&resourcetype=HWCIT

Abstract:

More independent resources and alternative ways to identify adverse events are key

The Food and Drug Administration of the United States is now the patient on the examining table, with no shortage of attending doctors or nostrums. Months ago, the agency sought the advice of the National Academy of Sciences’ Institute of Medicine on its drug safety system. The resulting report echoed previous suggestions that the agency should be given more money and power and proposed altering current industry approaches to drug development.1 2 3 4 The drug industry, already smarting from tightened FDA drug safety standards, went into defensive mode.

The Institute of Medicine report will certainly play a key part in an upcoming debate in Congress over renewal of legislation that empowers the FDA to collect fees for a portion of the cost of reviewing applications for drug approval. The current user fee legislation expires 30 September 2007 and must be reauthorised by then; this will provide a vehicle . . .