August 2, 2006
Supplements, OTC Drugs May Have to Report Side Effects
Legislation headed for a vote in the Senate would mandate for the first time that makers of dietary supplements and over-the-counter drugs inform the FDA when they learn of any serious adverse event linked to their products.
"The current reporting system is voluntary. It's not adequate for detecting the number or prevalence of adverse events associated with a product," said Sen. Dick Durbin (D-Ill.), a key backer of the bill.
The legislation defines a serious adverse event as a death, life-threatening experience, inpatient hospitalization, disability, birth defect or medical and surgical intervention.
The measure stems from concerns regarding the now-banned dietary supplement ephedra, which has been linked to dozens of deaths; from the dangers associated with the use of steroids and performance-enhancing substances by athletes; and from a variety of scientific reports raising doubts about numerous herbal products.
The legislation has support from major players in the supplement market -- but they're not interested in being treated the same as traditional pharmaceuticals:
But [industry spokesman] Mister said the industry will never back other legislative proposals that would require their products receive FDA approval for safety and efficacy before marketing.
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