U.S. Congress Underlines Importance of Mandatory Adverse Event Reporting

Passage of this initiative will enhance consumer confidence

Washington, D.C. (December 11, 2006)—The following is a statement from Linda A. Suydam, D.P.A., president, Consumer Healthcare Products Association (CHPA), in support of legislation requiring mandatory reporting to the U.S. Food and Drug Administration of serious adverse events associated with over-the-counter (OTC) medicines and nutritional supplements recently passed by both the U.S. House of Representatives and U.S. Senate.

"Despite the industry’s strong safety record, the Association has always believed that more can be done to further enhance consumer confidence in OTCs and supplements. As a strong and consistent supporter of mandatory reporting of all serious adverse events associated with dietary supplements and OTCs, CHPA was pleased to see recent progress made on the bill, and looks forward to seeing mandatory adverse event reporting for all OTC medicines and nutritional supplements become a reality. In addition to bolstering public confidence, the establishment of a mandatory system also will benefit manufacturers by standardizing the scope and extent of reporting to FDA."

Editor’s note: This legislation now moves to the President’s desk for signature. If enacted into law, this initiative will align monographed OTCs and nutritional supplements with the adverse event reporting requirements already present for OTC medicines under New Drug Applications.

Contact: Elizabeth Assey and Virginia Cox, 202.429.9260

CHPA is the 125-year-old trade association representing U.S. manufacturers and distributors of over-the-counter medicines and nutritional supplements.