What Makes an Industry Responsible?

Imagine a series of car accidents caused by defective tires that explode without warning; then imagine that rather than sharing that information with the National Highway Traffic Safety Administration, consumers, the tire maker or even with each other, the car manufacturers that received the defective tire reports decided to ignore the signs.

American consumers would be justifiably outraged if manufacturers knew of potentially serious issues associated with their products and failed to tell the federal agency that regulates them. So why should dietary supplements be any different?

That is the question that consumer organizations, state legislators and regulators have been asking the dietary supplement industry ever since news that one company failed to disclose thousands of adverse event reports (AERs) associated with ephedra was made public after the Food and Drug Administration (FDA) went to court to get those reports.

Manufacturers keep telling consumers, reporters, their insurance underwriters and government officials that serious adverse events involving dietary supplements are extremely rare—most companies only receive a handful in an entire year.Yet the people we are trying to persuade are quick to remind us that there is no requirement for manufacturers to back up their claim and produce the reports they do receive. This industry needs to stand behind the safety of its products, and a mandatory adverse event reporting law is the way to do it.

That is what Senate Bill 3546 is all about— proving to the world what we already know—that dietary supplements have a long and broad history of safe use and that our products are taken by millions of consumers everyday without serious harm. S. 3546 requires manufacturers of dietary supplements and over-the-counter (OTC) medicines to provide FDA with any reports they receive of serious adverse injuries or illnesses associated with their products within 15 days of getting that notice from a consumer, health care professional or emergency room. It requires product labels to include an address or phone number where consumers can report these incidents and requires companies to keep these reports for six years.

The legislation is not without risks, but the Senators who drafted this bill have taken steps to protect the industry from the misuse of these reports. The bill protects the personal information of people who file adverse event reports (AERs) so attorneys can’t use the reports as plaintiffs’ rosters for the next class action. It assures that reports of an injury that may be associated with a dietary supplement (at least, in the consumer’s mind) are not construed as an admission by the manufacturer that the product caused or contributed to the adverse event. It allows manufacturers to supplement the record with additional information (like medical histories, doctors’ reports, etc.) that tends to exculpate the products from having contributed to the adverse event. The bill also requires FDA to improve the way it collects and keeps adverse event data so that duplicate reports don’t artificially inflate the number of incidents FDA attributes to a particular product or ingredient. And it preempts states from creating their own reporting systems and assures that states can not use the data collected by FDA in ways that would be prohibited under the federal law.

Still there are critics of the bill who predict this legislation will open the floodgates of bogus AERs pouring in to companies; but, the logic doesn’t hold up. Consumers and health care practitioners already can, and do, report adverse events connected with dietary supplements directly to FDA through the Medwatch system. This legislation just ensures that all manufacturers play by the same rules.

So why should manufacturers of dietary supplements support this bill? Because it’s the right thing to do. It sends a loud message to our customers and to our critics that this industry stands behind its products.

In all responsible, robust, well-regulated industries, accidents can happen: a manufacturing line can break down, and an ingredient can become contaminated. Data from the marketplace can illuminate a previously undisclosed side effect or the need for a label precaution, as well as provide a signal of tampering or a bio-terrorism attack. Mandatory reporting of serious adverse events will give a single agency the ability to review this data and spot trends or “spikes” in reports that may identify a problem more quickly than companies could on their own. And if the anecdotal evidence from members of the Council for Responsible Nutrition (CRN) is right, five years from now, the dietary supplement industry will have an impressive safety record that is well-documented by FDA, showing supplements are a safe way to maintain good health and good nutrition.

By building relationships of trust between manufacturers and the regulators, legislators and journalists who cover our industry, and between our industry and the consumers who purchase our products, we will create an environment for sustained long-term growth.

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