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© 2005 Oxford University Press
NEWS |
FDA Attempting To Overcome Major Roadblocks in Monitoring Drug Safety
| The first 150 words of the full text of this article appear below. |
The voluntary manufacturer withdrawal of the COX-2 inhibitor Vioxx (rofecoxib) last fall prompted many critics to question why the agency charged with ensuring the safety of pharmaceuticals—the U.S. Food and Drug Administration—did not lead the effort to issue warnings or remove the drug from the market.
By some accounts, the FDA's system for reporting adverse drug reactions is overwhelmed and in need of reform. In addition, the agency lacks the appropriate authority to mandate that drug companies perform postmarketing studies, which could yield valuable safety information. But several new efforts suggest that the landscape for drug safety monitoring is destined to improve: The proposed 2006 federal budget includes a 24% increase in funds earmarked specifically for drug safety, the acting FDA commissioner has announced a broad plan to improve drug safety monitoring at the agency, and Congress is considering legislation that may give the FDA the funding and the authority