Food and Drug Administration

doi:10.1136/bmj.39049.545880.BE

BMJ 2007;334:55-56 (13 January), doi:10.1136/bmj.39049.545880.BE

Editorials

Food and Drug Administration

More independent resources and alternative ways to identifyadverse events are key

The first 150 words of the full text of this article appear below.

The Food and Drug Administration of the UnitedStates is now the patient on the examining table, with no shortageof attending doctors or nostrums. Months ago, the agency soughtthe advice of the National Academy of Sciences' Institute ofMedicine on its drug safety system. The resulting report echoedprevious suggestions that the agency should be given more moneyand power and proposed altering current industry approachesto drug development.¹ ² ³ ⁴ The drug industry, already smarting fromtightened FDA drug safety standards, went into defensive mode.

The Institute of Medicine report will certainlyplay a key part in an upcoming debate in Congress over renewalof legislation that empowers the FDA to collect fees for a portionof the cost of reviewing applications for drug approval. Thecurrent user fee legislation expires 30 September 2007 and mustbe reauthorised by then; this will provide a vehicle for newdrug safety . . . [Full text of this article]

Linda R Horton, partner

¹ Hogan and Hartson, B-1040 Brussels, Belgium

lrhorton@hhlaw.com