Monday, Dec.11, 2006
Manufactures must now report serious, adverse events from products to FDA
(Washington, D.C.) – Congress’ last-minute passage of a bipartisan dietary supplement bill will focus attention on adverse reactions that consumers suffer from supplements and various over-the-counter drugs, and should help identify those products that are most dangerous, Consumers Union said today.
“While consumers may think that dietary supplements are safe, the fact is these products are basically exempt from any meaningful safety rules and regulations,” said Bill Vaughan, senior policy analyst for Consumers Union, publisher of Consumer Reports.
The measure, S. 3546, would require that makers of dietary supplements and over-the-counter drugs inform the Food and Drug Administration when they learn of “serious adverse events” linked to their products. The bill, co-sponsored by Sens. Dick Durbin (D-Ill.) and Orrin Hatch (R-Utah), defines serious events as death, life-threatening experience, inpatient hospitalization, disability, birth defect or medical/surgical intervention.
“We thank Senators Durbin, Hatch and others for bringing attention to the deaths and injuries that sometimes accompanies the use or overuse of these products,” Vaughan said. “This new law will help ensure that serious adverse events are reported to the FDA, and enable the agency to begin to focus on the most dangerous of these products.”
Unlike prescription drugs, dietary supplements are not required to be proven safe and effective before being marketed. Consumers Union has urged Congress to require adequate pre-market safety testing of dietary supplements and to give the FDA more authority to remove dangerous supplements from the market once safety issues arise.
Vaughan said Consumers Union looks forward to working with the new Congress, including incoming committee chairmen Rep. John Dingell (Commerce) and Sen. Edward Kennedy (Health) to improve the safety and efficacy of dietary supplements.
“We hope Rep. Dingell and Sen. Kennedy will build on this legislation to make needed reforms that will ensure these products are safe and worthwhile,” Vaughan added.
Contact: Susan Herold, 202-462-6262