In a surprise move, the pending adverse event-reporting bill passed in the final hours of the 109th Congress' second session. The Dietary Supplement and Nonprescription Drug Consumer Protection Act cleared through the House of Representatives at 3:06 a.m. on Dec. 10. The Senate had voted the bill through just days before.
The bill amends the Food, Drug and Cosmetic Act to require reporting to the U.S. Food and Drug Administration all "serious" adverse events for both over-the-counter drugs and dietary supplements. "We have long said passing this legislation is the responsible, right thing to do for both the industry and consumers," said David Seckman, executive director and chief executive officer of the Natural Products Association, in a release.
The bill includes reporting of only serious events, exempts retailers from reporting and preempts any existing or future state reporting requirements. "Serious" is defined as anything that results in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, a congenital anomaly or birth defect, or requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described.
Also in a release, Michael McGuffin, president of the American Herbal Products Association, said, "This bill was passed by unanimous consent in the Senate and by more than a 2-to-1 majority in the House. Such broad and bipartisan support for this important legislation is significant."
The FDA will issue notification of reporting requirements within nine months of enactment, which will occur within one year of its being signed into law.
"We are confident that ultimately the AER system will highlight the strong safety record of dietary supplements and allow consumers to feel increased confidence about the choices they make when taking dietary supplements," said Council for Responsible Nutrition President Steven Mister, in a release. Sens. Orrin Hatch, R-Utah, and Tom Harkin, D-Iowa, introduced the bipartisan bill. The president's signature was still required on the bill at press time.
Natural Foods Merchandiser volume XXVIII/number 1/p. 27