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The time devoted to preapproval review, particularly for drugs deemed "priority," has dropped substantially since 1992.
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Some of the delay is inevitable: It's simply not possible to detect every risk before doctors start prescribing a drug. system for identifying drug risks before approval is flawed—and the one for spotting them afterward is even worse.
Doing so would require clinical trials that would be prohibitively large, long, and costly. The 2007 FDA Amendments Act promised many changes in the drug-safety system, but whether they will be sufficient, even if the agency uses its new powers effectively, remains to be seen.
The trials also tend to include few women and minority-group members.
And they often use clinical lab results—for example blood cholesterol levels—to determine how well a drug works rather that measuring how often it helps a person avoid having a heart attack or if it helps them to actually live longer.