Source:
NYTimesIndustry Years Behind on Testing Approved Drugs
By GARDINER HARRIS
Published: October 26, 2009
WASHINGTON — Federal drug officials have long been criticized for failing to force drug makers to complete studies proving that their drugs work as hoped, and Congressional investigators on Monday released yet another report pointing out that some of these studies remain undone many years after being promised.
The result is that doctors and patients remain unsure whether some critical medicines used to treat illnesses like cancer and heart disease are actually beneficial.
Concerns about this situation reached such a pitch several years ago that Congress passed legislation in 2007 giving the Food and Drug Administration greater power to force drug makers to complete their promised studies and to fine companies that fail to follow through.
In a report released Monday, the Government Accountability Office said that from 1992 through Nov. 20, 2008, the food and drug agency asked drug makers to complete 144 studies associated with 90 drug applications, and that drug makers had completed just two-thirds of the requested studies. Fifteen of the 52 uncompleted studies have been pending for more than five years, and several have been pending for more than eight years, the report said.
Read more:
http://www.nytimes.com/2009/10/27/health/policy/27fda.html?_r=1&ref=us
Charles Grassley wants a real genuine working FDA?
Whoda thunk it?