Rapid approval process broken, says congressman
Patient Safety Monitor Alert, June 2, 2005
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The Food and Drug Administration's new rapid approval process for new drugs may harm patients because of a lack of oversight, according to a Reuters report.
Congressman Ed Markey (D-MA) said the drug companies are not completing required follow-up studies and the FDA is not double-checking to see that work is done. The result is a lax system which may allow unsafe drugs onto the market, Markey said.
Officials at the FDA said the process is instrumental in getting helpful drugs on the market. Pharmaceutical companies point to the low rate of recall on drugs as proof that the system is safe.
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