Drugs Trials That Don't Happen
March 2006
Drug makers aren’t keeping their promises, according to the Food and Drug Administration (FDA). Drug trials slated to detect the effectiveness of drugs and if they produce any unwanted side effects are never taking place. Now, the FDA is being criticized for not being tough enough on drug manufacturers that make these promises in order to get their drugs on the market more quickly.
As of September 30, 2005, 797 out of the 1,231 promised drug trials, or 65 percent, had not begun or were pending, according to the FDA. One study even dated back to 1955. Reasons for the delay include high costs and few incentives to actually complete the trials. The FDA could pull the drugs from the market if the trials are not completed in a specified time frame, but they have never actually done this for fear of hurting the patients.
The director of the Office of New Drugs for the FDA stated that only 5 percent of the promised drug trials were delayed. The agency claims the rest of the pending trials are not technically delayed because a timeline for the tests was never determined.
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Source: “New Drugs Hit the Market, but Promised Trials Go Undone.” By
Gardiner Harris. New York Times. March 4, 2006.



