In a report to be released today, the FDA was found to do very little to ensure the safety of people who help test drugs in clinical trials.
An article in the New York Times quotes Daniel Levison, Inspector General for the Department of Health and Human Services as saying that FDA officials are not aware of how many clinical trials are being conducted and have audited fewer than 1 percent of trials.
The New York Times reports that the FDA has 200 inspectors that are required to monitor over 350,000 testing sites and that top drug officials downgraded negative findings their reports 68% of the time.
Levinson recommended that the FDA create a registry of all clinical trials so that these trials may be better monitored.
Drug companies are forbidden to promote medications for uses that have not been validated by the FDA on evidence from clinical trials. Also, under guidance proposed by the FDA this year, drug companies could distribute to doctors scientific articles that suggest new and unapproved uses for medications.
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Brian
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Posted by: Brian2008 | November 12, 2008 1:01 AM | Permalink to Comment