The Case for Mandatory Reporting of Adverse Events

The Case for Mandatory Reporting of Adverse Events
by Steven M. Mister, Esq.

Editor’s Note: INSIDER welcomes Industry Commentary/Opinion contributions and Letters to the Editor. Submissions may be edited for content and clarity and do not necessarily represent the views of Virgo Publishing or INSIDER.

These are serious adverse events (AEs), legally defined as the use of a product that is associated with a negative occurrence that leads to death, a life threatening experience, hospitalization, a persistent or significant disability or incapacity, or a congenital anomaly or birth defect.These would be pretty serious outcomes from products that can be sold without intervention of a health care provider and are available from retailers and direct distributors all over the country.

What happens when the product manufacturer is notified with this information? Right now, by law, nothing. Although many manufacturers voluntarily relay this information to the Food and Drug Administration (FDA), Congress is now considering whether to make it mandatory for dietary supplement manufacturers to notify FDA when they receive reports of serious adverse events.

Just what does FDA do with the voluntary information it now receives? The agency says it treats adverse event reports (AERs) as “a monitoring tool to identify potential public health issues that may be associated with the use of a particular product already in the marketplace.” In other words, AERs provide early warning signals of a potential health issue from regulated products (from drugs to cosmetics to foods) that wouldn’t necessarily be identified in a closely monitored, limited universe clinical trial. For supplements that don’t require pre-market approval, the ability to monitor usage and collect data in the general population can head off a public health problem before it escalates.

The Council for Responsible Nutrition (CRN) and other industry associations are not only consenting to, but are actively backing, this mandatory AER measure as a positive step toward building consumer confidence in dietary supplement products. Yet support for this proposal is not unanimous. Why should the dietary supplement industry support this initiative?

First of all, it’s the responsible thing to do. AERs do provide early warning signals to FDA of potential product problems: product contamination or adulteration, tamperings, bioterrorism and ingredient safety issues. By providing this information to a single source, manufacturers increase the likelihood that trends indicating a problem will be identified more quickly (even across competitive brands), and fewer consumers will be affected. If we’re serious about growing the dietary supplement market, we must go beyond our current loyal users to attract those consumers who currently say they don’t trust the safety of our products. Assuring them, and FDA, that the industry has nothing to hide—and that serious AEs connected with dietary supplement usage are relatively rare—will build that trust.

Critics of AE reporting for dietary supplements worry that it will embolden plaintiffs’ attorneys with new fodder for class action litigation; their concerns are not without merit. But there are several reasons to discount these objections.These naysayers who predict a flood of new AERs mistake the proposal for a federally mandated campaign offering consumers cash every time they call the manufacturer to report a hiccup on the water they swallowed with the supplement. Legislation wouldn’t drive people to file more reports; rather, it would only require manufacturers to notify FDA of the reports they receive. And only “serious” AEs would be covered, not every tummy ache or freckle that consumers report.

Consumers already have information on the label (including Web sites or toll-free phone numbers) to encourage them to contact the manufacturer with comments or complaints. Many consumers even contact FDA directly through the Medwatch program. So the prediction of open floodgates releasing bogus reports doesn’t add up. In addition, most manufacturers say they already voluntarily notify FDA of AEs involving their products, so this information is already a matter of public record. A new law would ensure all manufacturers are playing by the same rules. Further, the industry has been telling Congress and FDA that serious AEs connected with dietary supplements are relatively uncommon.The low incidence of negative effects is one of the reasons the Dietary Supplement Health and Education Act (DSHEA) was enacted. It’s time we put our reporting where our mouths are and demonstrate that.

Moreover, there are numerous protections for AERs that will limit their benefit to plaintiffs in product liability litigation. First, any information included in a report that reveals the identity of the subject is redacted before the report can be released. The patient privacy protections of the federal Privacy Act and Health Insurance Portability And Accountability Act would apply to dietary supplement reports just as it does pharmaceutical AERs. In addition, a federal AER system would presumably be subject to section 756 of the Food, Drug & Cosmetic Act, which assures any submission of a safety report shall not be construed as an admission that the product contributed to an adverse experience, or otherwise caused or contributed to death, serious injury or serious illness. Finally, manufacturers are free to submit, along with the AER, any follow up they conducted that discounts the causation of the event, as well as a statement that denies any connection between their product and the AE. This information then becomes part of the report that would be accessible in the future.

Still skeptical about the liability? Then consider that early reporting to FDA might just identify a tampering or adulteration more quickly and thereby limit the extent of the problem—as well as the number of disgruntled consumers looking to sue.

Even if Congress wasn’t interested in AE reporting, the reality is that several states are. Last year, legislators in California came close to approving legislation that would have required reporting of AEs from all over the country to regulators in Sacramento. Similarly, New York’s Task Force on Life and the Law issued a report in October 2005 urging the creation of a state-run mandatory AE reporting system for manufacturers doing business there. States share their ideas, and it is easy to imagine a future with half a dozen or more states establishing their own AE reporting requirements, each slightly different. If a single federal AE reporting system includes pre-emption of a patchwork of state reporting systems, a federal alternative is certainly preferable, as AERs would be filed to one federal agency, instead of multiple state agencies, each of which could have its own requirements.

Still, some argue the industry would be better off if Congress simply required supplement labels contain the toll-free number for FDA’s Medwatch program. That would mean consumers would call FDA with any product complaints or concerns, instead of contacting the manufacturer. Don’t responsible manufacturers want to know about their consumers’ concerns first? And isn’t it preferable to have consumers first call the manufacturer, which then has a chance to investigate, filter out the non-serious reports, determine what corrections may be in order, and ultimately inform FDA with all the relevant data at once?

Passage of mandatory AE reporting in this Congress is far from a certainty. There are factions in Congress that will suggest pre-market approval is the better alternative, and industry—and the industry’s customers—won’t stand for that. At the other extreme, there are industry members who believe any oversight by FDA infringes on their right to market whatever they want. However, that view fosters a growing mistrust of supplements by consumers and prevents dietary supplements from gaining acceptance among health care practitioners who are in a position to be important proponents for our products. Instead, we have an opportunity to show our customers and other key stakeholders that our products are as safe as we say they are.

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