Major industry players are applauding a bill that will require reporting of "serious" adverse events for both dietary supplements and over-the-counter drugs. Sens. Orrin Hatch, R-Utah, Richard Durbin, D-Ill., and Tom Harkin, D-Iowa, introduced the Dietary Supplement and Nonprescription Drug Consumer Protection Act on June 21. On June 28, the bill passed out of committee for a full Senate vote.
Industry groups such as the American Herbal Products Association, Council for Responsible Nutrition and National Nutritional Foods Association, as well as citizen groups such as Citizens for Health, have all come out in favor of the bill.
According to Susan Brienza, a lawyer with Denver-based Patton Boggs, the bill—S. 3546—would require manufacturers, packers and distributors of nonprescription medications and of dietary supplements to include an address or phone number on product labels for the reporting of adverse events. Companies would have to report "serious" adverse events to the U.S. Food and Drug Administration within 15 business days. "Under Sec. 3, 'serious' is defined as an adverse event that: A. results in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, or a congenital anomaly or birth defect; or B. 'requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described' in A," she said.
In a release, NNFA called the bill, "A fair and meaningful collaboration among the industry, our champions in the Senate and legislators who would like to see more stringent oversight of dietary supplements."
Marc Ullman, a partner with New York City-based Ullman, Shapiro and Ullman, said, "The way [the AER bill has] been handled reflects favorably on our trade associations and leadership and their ability to work on The Hill." However, he noted that there are "still a couple of influential groups out there that don't like this legislation, don't see FDA implementing it fairly and don't trust any bill that Sen. Durbin thinks is a good idea."
And while industry lawyer and consultant Loren Israelsen voiced his own reservations, he said, "The transcendent issue is maintaining trust with our consumers, the confidence of Congress and the viability of [the Dietary Supplement Health and Education Act]."
And, in so much as the bill may help the embattled industry image, Israelsen said the bill should help bolster consumer confidence. "I think it should be seen as a fundamental obligation of our industry, that if our consumers have concerns and questions, that we resolve the concerns and answer the questions," he said. "I think that's called Business 101."