Adverse Event Reporting Law

The Dietary Supplement and Non-Prescription Drug Consumer Protection Act (the “AER Bill”)—legislation resulted from political compromise among a number of senators with input from industry—was introduced on June 21, 2006. It amended the federal Food, Drug and Cosmetic Act to require the reporting of “serious” adverse events for both over the counter (OTC) drugs and dietary supplements.

As word of AER-related legislation spread, it became clear that many in the industry can benefit from information regarding the background of this bill, including what is required and of whom, what is not required, and the impact of the legislation on the industry. The biggest benefit of the bill to the dietary supplement industry is that it thwarts continuing media articles stating that dietary supplement safety is not monitored.

Background: Political Compromise Among Policymakers and Industry Representatives

The AER bill was the result of a political compromise and a collaborative effort among such industry Congressional Champions as Senators Orrin Hatch and Tom Harkin on one hand, Senator Richard Durbin, who favors more stringent regulation of the industry, including pre-market approval, on the other hand, and Senators Michael Enzi and Ted Kennedy, then leaders of the Senate Committee on Health, Education, Labor and Pensions, with input from members of the dietary supplement and OTC drug industries.

Throughout the legislative process, the Natural Products Association and other associations were given the opportunity to provide input into the AER bill. The NPA team emphasized that a meaningful and fair AER bill must:

  • Be limited to serious adverse events only and not require reporting just any complaint
  • Include OTC drugs
  • Not require retailers to report
  • Be limited to products sold in the United States
  • Allow third parties to report or evaluate claims
  • Preempt state AER legislation

Because these objectives were achieved and for some of the reasons discussed below, the Natural Products Association Board of Directors decided to support the AER bill.

Key Provisions of the AER Bill
The AER bill requires “responsible persons”—defined as manufacturers, packers or distributors of OTC drugs and dietary supplements—to submit any serious adverse event to the Food and Drug Administration (FDA) within 15 business days of learning about it. The responsible persons must submit any additional information concerning the adverse event of which they become aware within one year of the initial AER (within 15 days of receiving the additional information). The AER bill makes it unlawful to submit false serious adverse event reports to a responsible person or to the FDA.

The reporting requirements do not apply to retailers who do not market products under their own name. Although the reporting requirements apply to “distributors whose name…appears on the label,” a retailer who has private label products and whose name appears on a supplement label may, by agreement, authorize the manufacturer or packer of the product to submit all of the required reports and thus not bear responsibility for reporting to FDA.

The AER bill, which took effect one year after becoming law, defines a “serious adverse event” as an experience that results in any of the following:

  • Death
  • Life-threatening experience
  • In-patient hospitalization
  • Persistent or significant disability or incapacity
  • Congenital anomaly or birth defect
  • Requires medical or surgical intervention to prevent the above outcomes

Although the AER bill only requires that reports of “serious” adverse events be submitted to the FDA, records of other types of product complaints or adverse events must be maintained for a period of six years by the responsible person. To reiterate, this recordkeeping and reporting provision does not apply to retailers.

AERs Not Proof of Causation

The AER bill provides that the submission of any serious adverse event report shall not be construed as an admission that the product caused or contributed to the adverse event. Also, all serious adverse event reports submitted to the FDA pursuant to the AER bill are considered to be safety reports and would be available only through a Freedom of Information Act (FOIA) request and will not be disclosed unless all personally identifiable information is redacted.

Other State and Local AER Related Laws Not Identical Will Be Preempted

Some states have considered mandatory AER reporting in various dietary supplement related bills. The federal AER bill preempts all state and local laws or regulations relating to adverse events that have different requirements than this legislation. Because state and local governments are prevented from enacting different AER reporting requirements, the industry will not be forced to adhere to varying, and potentially more onerous, requirements from state-to-state.

Impact on the Industry

The mandatory reporting requirements of the AER bill will add to manufacturers’ record-keeping responsibilities. Although there had been much confusion about specifically what level of reporting is required, “responsible persons” will only be required to report to the FDA adverse events that qualify as “serious.”

These increased responsibilities on the part of manufacturers will likely benefit the industry in the long run. First, the AER bill will help improve the public perception of the dietary supplement industry by demonstrating that-contrary to media reports-the industry is regulated.

Second, over time, the recordkeeping and reporting requirements also will substantiate what many in the industry have long been saying—that the safety record of dietary supplements compares favorably to other health-related products.

Ultimately, safety reporting is the right thing to do. A responsible industry and responsible manufacturers put consumers first. An industry system that puts consumers first will increase consumer confidence and will reap the corresponding benefits.