The Fox Is Now in Charge of the Hen House
EDITORIAL

The Fox Is Now in Charge
of the Hen House

Adverse Event Reporting Bill Is Signed into Law

n December 22, 2006, President George W. Bush signed into law the Dietary Supplement and Non-Prescription Drug Consumer Protection Act (the “Adverse Event Reporting,” or AER, bill), S. 3546. Hailed by the Council for Responsible Nutrition and other industry groups as a great triumph, it is difficult to see why we should celebrate, given the history of the FDA and its attitude toward supplements. Although many do not remember, the Dietary Supplement Health and Education Act (DSHEA) of 1994 was designed to protect the industry from the FDA’s excesses, which until then had been onerous, to say the least. As written, the AER law—introduced by Senators Kennedy, Harkin, Durbin, and Hatch—ends up giving back to the FDA a great deal of discretionary power that was taken away by DSHEA.

Guilty Until Proven Innocent

DSHEA was careful to place the burden of proof for the safety of supplements on the FDA, where it belongs. In fact, the establishment and maintenance of safety standards was the original raison d’être of the FDA when it was created in 1906. By contrast, the AER law puts the burden of proof on the manufacturer, reversing the intent of DSHEA, which propounded that supplements are far safer than many common foods. Thus they should not be treated like drugs—this is precisely what DSHEA tried to prevent. A reversal of the burden of proof is the equivalent of the totalitarian tenet “guilty until proven innocent.” It is a legislative travesty!

The new law mandates that complaints regarding dietary supplements be routed from local responders—including doctors, hospitals, and poison control centers—to the product manufacturers.* Expert scientific and medical opinions are thereby left out of the equation. To protect the identity and privacy of the individual complainant, the law refers to the Privacy Act of 1974 and then stipulates that access to this information be exempt under the Freedom of Information Act—no information can be revealed without redacting all personally identifiable information. Although this appears laudable, there would then seem to be little or no liability in initiating a complaint in the first place. The section prohibiting falsification is ineffectual, because proof of causation is not required, and medical records are withheld from the company filing the report. The complainant doesn’t even have to be the one harmed! In effect, there are no real safeguards against malicious complaints.


*It’s worth noting that the routing feature will decrease response times in the event of any terrorist contamination of supplements.


Unsubstantiated Notice of Adverse Events

Furthermore, the bill will encourage publication of all AERs without proof of causation, thus confusing consumers. Overall, the system encouraged by the law will increase the likely number of AER complaints, masking true instances of harm in a sea of unverified allegations.

Not only will the public be misled, but this process of derogatory publication could also destroy the reputations of manufacturers without offering any means of redress. Worse yet, while the burden of evaluating the complaints is foisted on the manufacturers, the law actually prevents the company’s right to review the medical information necessary to perform that evaluation. How can a company unable to determine the cause defend itself against a false charge? Moreover, anyone with a vendetta against a company can simply complain that someone—anyone!—was seriously injured by a supplement, and the company must report the complaint to the FDA. The FDA will then disclose it, resulting in potentially unjustified defamation of the company.

A Bill Written in the Spirit of Kafka

Finally, no proof of actual injury is required before tax dollars are spent to investigate. The law’s defenders have said that, given the impending change in the composition of Congress, the results could have been much worse if the bill had been postponed. Yet it’s hard to see how. Franz Kafka is alive and well.

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