Mandatory AER Bill Emerges

WASHINGTON--On June 21, Sens. Orrin Hatch (R-Utah), Tom Harkin (D-Iowa) and Richard Durbin (D-Ill.) introduced a mandatory adverse event reporting bill for dietary supplements and nonprescription drugs. The Dietary Supplement and Nonprescription Drug Consumer Protection Act (S.R. 3546) will require companies that sell dietary supplements and over-the-counter (OTC) drugs to forward to the Food and Drug Administration (FDA) any serious adverse event reports (AERs) they receive from their customers.

If passed, the bill will require companies to include on their product labels an address or phone number through which consumers can report adverse events that they associate with their use of a supplement or OTC drug. These companies will be required to notify FDA of any serious AERs they receive within 15 business days.

According to Steve Mister, president and chief executive officer (CEO) of the Council for Responsible Nutrition (CRN), this bill does two things: "First, it demonstrates a commitment to consumers by ensuring that the agency that regulates the supplement industry is informed of any serious problems associated with our products. As importantly, it also includes appropriate protections to help ensure that unjustified burdens are not placed on responsible companies."

This bill is a long-awaited result of a promised joint effort from industry allies Hatch and Harkin and industry critic Durbin. Sens. Michael Enzi (R-Wy.) Edward Kennedy (D-Mass.) also joined the effort. Industry groups joined a chorus of supporters commending the bipartisan work on this newly proposed legislation.

However, what may seem like a new safety and quality regulation is actually not new to the dietary supplement industry. CRN said it has long supported the concept of mandatory reporting for serious adverse events, calling it the right thing for a responsible industry to do. "UNPA has long supported a serious adverse event reporting system for dietary supplements as part of the overall implementation of DSHEA," added Loren Israelsen, executive director of the Utah Natural Products Alliance (UNPA). "We believe dietary supplements are exceptionally safe products and that this legislation will in future years confirm this fact. We also recognize that should a safety problem arise, we as an industry have a responsibility to quickly identify and resolve such situations and to do so in cooperation with FDA in those cases where the adverse event is serious."

Others agreed, even voicing historical support for such mandatory AERs. "The Board of the American Herbal Products Association [AHPA] adopted a position in October 2002, calling for a regulatory change to mandate that serious adverse event reports associated with supplements be forwarded to FDA," commented Michael McGuffin, president of AHPA. "AHPA communicated its decision to Sens. Hatch, Durbin and Harkin at that time, and has worked closely with their offices to reach this important goal."

Mister stated this bill punctuates the fact that the supplement industry is regulated and that companies are committed to making regulation work. "If a consumer contacts a company with a concern that she suffered a serious injury or hospitalization and believes the event is associated with use of one of our products, she has a right to expect that the complaint will be shared with the regulatory agency that oversees the industry, in our case, FDA," he said. "We look forward to the expedient consideration and passage of this bill in the Senate and encourage the House of Representatives to take similar steps."

Israelsen added, "We also believe this legislation goes some distance to respond to criticism that the dietary supplement industry is unregulated."

McGuffin summed up the potential impact of the bill. "Dietary supplements, as a class, have a remarkable safety record," he said. "The many Americans who use them responsibly can continue to exercise their freedom of choice, knowing that the rare problems that might be reported will generate the signals that are needed to inform FDA. And marketers of these products can be certain that they will be provided with the same kinds of protection that the pharmaceutical industry enjoys, so that this system does not penalize companies that comply."