Preparing to Comply with the New AER Reporting Law

If your company manufactures, distributes or imports any dietary supplement or over-thecounter (OTC) product, it is essential to give yourself adequate time to prepare for mandatory reporting of adverse events to the Food and Drug Administration (FDA).

As was widely reported in the industry and mainstream media, after two years of bipartisan discussions in Congress and the eventual support of both Houses of Congress, President Bush signed into law the Dietary Supplement and Nonprescription Drug Consumer Protection Act (DSNDCPA) in late December, 2006.

The law requires FDA to issue a guidance document on the minimum data elements that should be included in a serious adverse event report (AER) within 270 days of the date the bill became law. Thus, the requirements will be released by Sept. 22, and the bill goes into effect Dec. 23, 2007.

It will be the responsibility of the dietary supplement manufacturer, packer or distributor, whose name appears on the label of the product marketed in the United States (hereafter referred to as the “responsible person”), to report any serious adverse event associated with the use of the dietary supplement when reported by a consumer, accompanied by a copy of the label or retail packaging of that product.

The law defines “adverse event” as any health-related event associated with the use of a dietary supplement that is adverse. Knowing what the definition is of a serious adverse event is important.

A “Serious Adverse Event” is defined under DSNDCPA as an adverse event that (a) results in: (i) death; (ii) a life-threatening experience; (iii) inpatient hospitalization; (iv) a persistent or significant disability or incapacity; or (v) a congenital anomaly or birth defect; or (b) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described by “(a)” above.

All AERs will be reported using FDA Form 3500 once the law goes into effect. The form is online now and can be reviewed for familiarity’s sake prior to the law’s implementation (visit http://www.fda.gov/medwatch/SAFETY/3500.pdf). If you feel intimidated by Form 3500 (also known as the “MedWatch” form) or feel it does not adequately provide space to address issues related to dietary supplements, you are not alone. Currently Form 3500 is “voluntary.” However, after Dec. 23, it becomes mandatory for a distributor, importer or manufacturer who receives an AER from a consumer to submit that report to FDA using this form. Unfortunately, Form 3500 needs some modifications to deal with adverse events purported to be due to dietary supplements. It may take a year or more before a suitable alternative to Form 3500 is available. The form works well for OTCs, but has inadequacies when reporting adverse events associated with dietary supplements. The law does allow FDA to modify Form 3500 for dietary supplements. If and when such a modified form will be made available is unknown. Until then, become familiar with Form 3500, or seek out a professional service that can help collect and categorize data to be included in the form and can submit the form to FDA on your company’s behalf.

It is particularly important that when submitting Form 3500 to the FDA you fill in all 31 boxes/items. Any item not checked or filled in could result in FDA contacting you about the missing information.

How quickly should the form be submitted to FDA after receiving a consumer complaint? Answer: Within 15 business days. Not 16.

Fifteen days. If FDA contacts the responsible person regarding an A E R submission, they must respond back to FDA within the prescribed period of time required and requested by FDA.

With some adverse events, it may not be possible to receive all of the medical information related to the event within 15 days. For this reason the law requires the responsible person to submit to FDA any new medical information related to a submitted serious AER that is received by the responsible person within one year of the initial report, no later than 15 business days after the new information is received by the responsible person.

To avoid multiple reports on the same event, FDA is required to consolidate reports on the same case. This will avoid including erroneous serious adverse events found in the previous adverse events monitoring system (AEMS) that FDA maintained until 1999. In 1997, I notified FDA, the National Institutes of Health (NIH) and members of Congress that I had discovered very serious errors in AEMS. For example, one man was found in AEMS who had died nine times, yet there was no record of any such death among various public health agencies (even if it could have been possible). In another case, the complain antcited a particular product in his AER; however, upon further inspection, that product was never manufactured by the named company. I authored a paper providing a historical accounting of the many serious errors discovered and the eventual impact the discovery of these errors had in terminating AEMS—setting the stage for the creation of DSNDCPA by Congress; the paper is being released in the May 2007 issue of the Journal of Orthomolecular Medicine (“False and misleading information in U.S. FDA’s adverse events monitoring system (1994-1999).” 22(1):11-20). For a copy of the paper, send a request to AIBMRinfo@AIBMR.com. 

Another issue is how long to keep records of AERs. The new law requires the responsible person to maintain records related to each AER received by the responsible person for a period of six years. Credentialed officers or employees of the Department of Health and Human Services (HHS) will be allowed to inspect those records; so, it is important to know who the responsible person is, where they are located, how to reach them if an inspection is requested, and be able to readily access those records.

The law does provide some protections. For example, the law provides that submission of any AER shall not be construed as an admission that the dietary supplement involved caused or contributed to the adverse event; and, submission of Form 3500 may be accompanied by a statement, which will become a part of any report that is released for public disclosure, that denies the report constitutes an admission that the product involved caused or contributed to the adverse event. Further, a record about the individual who is the subject of the adverse event shall not be publicly disclosed unless all personally identifiable information is redacted (as required under the Privacy Act of 1974).

Can false reporting of an adverse event occur? Yes, although the law has a provision prohibiting falsification of a serious adverse event submitted to a responsible person (Section 4(ii)). Professional services that have experience in pharmacovigilance associated with drug adverse event reporting have learned many ways in which false reports can be determined, which can be equally applied to serious adverse events claimed to be due to a dietary supplement.

Companies can also work with an third-party firm to handle AER submissions. A good choice would be a company that has licensed health care staff familiar with how such a report should be handled. It is important to ensure the company is licensed as a professional corporation and staffed by licensed health care workers. The normal procedure would be that upon receiving an AER, the caller would be transferred to that outsourced service; then the service would query the caller and fill out Form 3500.

The law does require that companies ensure every dietary supplement product you produce or distribute has either a domestic phone number or domestic address on the label/packaging that the consumer can use to contact you about serious adverse event. If that information is missing, the dietary supplement will be misbranded under the Federal Food, Drug, and Cosmetic Act (FFDCA) 

It is never too soon to begin discussions within your company on how you plan on handling AERs, and determining whether outside assistance may be required. Finally, note that companies that produce or distribute OTC products should review the new law carefully, because even the definition of what constitutes an adverse event is different than that defined for dietary supplements. 

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