FDA spokeswoman Sandy Walsh said the reasons for the increase weren't all known. However, she pointed to an increase in public attention to drug safety and use of the Internet to make it easier for consumers to submit adverse-event reports.
The FDA also said it has "undertaken a pilot program to review the safety of new molecular entities about 18 months after approval. We will determine if this formal, systematic review adds value to our current processes. If we were to do this on a full scale, we would need more staff resources."
That still begs the question of what to do about a growing and serious safety problem. According to the study authors, regulatory issues may be at the heart of the problem.
"I think it's very clear that we need to spend more money, more people, and we need more authority and more independence for the FDA drug safety program," Moore said.
In a prepared statement, the FDA said the study's findings were in keeping with what the agency had been seeing.
Visit the FDA for more on its drug safety initiative.
SOURCES: Thomas Moore, senior scientist, drug safety and policy, Institute for Safe Medication Practices, Huntingdon Valley, Pa; Sandy Walsh, spokeswoman, U.S. Food and Drug Administration; FDA prepared statement, Sept. 10, 2007; Sept. 10, 2007, Archives of Internal Medicine
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