Congress asks GAO for clarity on adverse event reporting
The reporting of adverse events (AER) by manufacturers, packers, and distributors of dietary supplements in the US was signed into law on December 22, 2006, with compliance effective one year later.
Despite initiatives such as the FDA’s MedWatchPlus web portal, Sen. Durbin and Rep. Waxman have said that: “To date, however, it is unclear how the AER system is working in practice”.
In a letter dated November 8, 2011, they called for the GAO to provide answers to seven questions, including the number of AERs filed since 2007, the kind of supplements implicated, the types of AERs, and steps being taken by FDA to ensure filing by manufacturers and suppliers, to inform consumers, and the extent of FDA implementation of the GAO recommendations from 2009.
The letter is available here via a posting on the blog of law firm Hyman, Phelps and McNamara.
Commenting on the request, John Gay, executive director and CEO of the Natural Products Association (NPA), told NutraIngredients-USA that “a fair review of the AER system, the creation of which NPA supported, would demonstrate the strong safety record of dietary supplements.
“The references in the letter to the 2009 recommendations are not needed, but do show that Senator Durbin still has the industry in his sights.”
Mike Greene, VP of government relations for the Council for Responsible Nutrition (CRN), told this website that CRN is very interested to see the results of the GAO’s report.
“Dietary supplements are overwhelmingly safe, and the AERs will prove this,” said Greene. “We’re glad there is post-market surveillance, and the numbers for dietary supplements are very small.”
