HerbalEgram

FWD 2 HerbalEgram

HerbalEGram: Volume 6, Number 8, August 2009

FDA Releases Final Guidance on Serious Adverse Event Reporting and Recordkeeping

The US Food and Drug Administration (FDA) announced on July 14 that it has released its final guidance for the dietary supplement industry on adverse event reporting and recordkeeping, as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (“the Act”).¹

The Act, which went into effect in December 2007, requires that marketers of dietary supplements submit to the FDA within 15 business days any serious adverse event reports (SAERs) that the marketer receives regarding a product, as well as keep records of reported serious adverse events for 6 years. The new final guidance document contains information, through a question and answer format, on the minimum data elements for SAERs, as well as guidance on record maintenance and access.

“The final guidance simply reflects FDA’s thinking regarding best practices for companies to follow in meeting both the letter and intent of the new law,” said Rick Kingston, PharmD, president of SafetyCall (e-mail, July 23, 2009). “FDA wants to be confident that if someone uses a manufacturer’s product and has an unintended effect and then contacts the manufacturer to seek advice, assistance, refund, or just let them know what happened, the manufacturer must have systems in place to ensure that their voice is heard, and if applicable, they will share the consumer’s experience with the FDA.”

Kingston added that there are multiple ways that responsible companies have been able to meet their SAER reporting obligations, including setting up in-house systems or outsourcing to experts that have cost-effective, turnkey systems. Those companies, however, that are doing nothing to track serious adverse events or have implemented inadequate reporting systems are failing to meet the letter and intent of the law, and those companies will be targeted by the FDA for compliance checks or safety reviews. Companies that do not track adverse events or that deny receiving adverse event reports constitute a problem within the dietary supplement industry.

“Someone is going to use a product and coincidently experience common life illness and wonder if there is a relationship and report their experience to the manufacturer,” said Kingston. “Even companies that sell water experience this. Receiving reports like this help create confidence with regulators that if someone really does have an effect that signals a safety concern, the manufacturer will hear about it and, if applicable, report it to the FDA. That’s what postmarket surveillance is all about. The law has actually helped many companies document the safety of their products, but sometimes it’s difficult for companies to know how to use the information to their benefit.”

The FDA issued a draft guidance concerning adverse event reporting and recordkeeping of dietary supplements in October 2007, and the public was invited to submit comments.² The American Herbal Products Association (AHPA) submitted comments recommending clarification of certain sections of the guidance. For instance, the Act defines a “serious adverse event” as an event that results in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, or a congenital anomaly or birth defect, or an event that requires a medical or surgical intervention to prevent one of those conditions based on reasonable medical judgment. AHPA commented that the draft’s description of “inpatient hospitalization” could be misinterpreted such that “the act of seeking treatment at a hospital emergency room for a minor adverse event could be erroneously considered to be a serious adverse event.” The final guidance, in its definition of a “serious adverse event,” refers to an appendix that clarifies that emergency room visits do not necessarily constitute inpatient hospitalization. In addition to this example, AHPA has stated that the FDA addressed other minor requests for clarification or rewording in the final guidance.

“Although none of these details are in and of themselves of great significance, it is satisfying to know that the efforts of AHPA’s Government Relations Committee and our board and counsel were not wasted,” said AHPA President Michael McGuffin in an AHPA press release.² “This FDA guidance now provides a useful resource for responsible persons to comply with the SAER law.”

The final guidance is available at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/DietarySupplements/ucm171383.htm.

The final guidance does not address the topic of labeling requirements of the Act. A draft guidance concerning the Act’s labeling requirements was issued by the FDA in January of 2008, and that draft guidance became the object of intense criticism by dietary supplement trade associations. An article in HerbalGram 78 addressed the reactions of trade associations to that draft guidance.³ An article in HerbalGram 73, meanwhile, provides some history of the Act and more information about SAERs.⁴

—Courtney Cavaliere

References

1. Food and Drug Administration. Guidance for industry: questions and answers regarding adverse event reporting and recordkeeping for dietary supplements as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act; availability. 74 Federal Register 133; July 14, 2009.

2. FDA issues final guidance on SAER reporting, recordkeeping: AHPA comments incorporated in revisions to draft [press release]. Silver Spring, MD: American Herbal Products Association; July 14, 2009.

3. Cavaliere C. Trade associations request withdrawal of FDA’s draft guidance on labeling requirements of AER Act. HerbalGram. 2008;78:58-59.

4. Cavaliere C. President signs new law to require reporting of serious adverse events of dietary supplements and OTC drugs. HerbalGram. 2007;73:60-61,75.