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Global Evolutions

Associations Help Industry with AERs

Supplement companies are required by law to submit serious adverse events to FDA within 15 days of becoming aware of them. While many major players in the industry submit adverse event reports (AERs) diligently, FDA said not every company has not lived up to expectations in a recent webinar jointly presented by the American Herbal Products Association (AHPA), Consumer Healthcare Products Association (CHPA), Council for Responsible Nutrition (CRN), Natural Products Association (NPA) and United Natural Products Association (UNPA).

Daniel Fabricant, Ph.D., Director, Division of Dietary Supplements, FDA, said FDA plans to increase it's enforcement of AERs submittals. The small numbers of AERs leads the agency to believe many companies are not submitting their adverse events to FDA. He noted FDA GMP inspections have companies have underreported their adverse events. For instance, he  pointed to a warning letter the agency sent to Quincy Bioscience noting inspectors found record of more than 1,000 adverse events that consumers reported to the company that were not reported to the agency.

He also noted the Federal Food, Drug and Cosmetic Act requires a supplement company to include a domestic address or phone number on the label; this number is for consumers to report adverse events. However, he said inspections showed some companies list FDA's Medwatch numberthe number companies, health care providers and consumers use to report AERswhich does not fulfill the requirements of the law.

Fabricant said supplement companies need to:

  • Label products correctly
  • Have standard operating procedures (SOPs) for AER and product complaints
  • Train employees on AER procedures
  • Follow-up on reported adverse events
  • Monitor indirect sources of information (such as social media, news, etc.)

In a separate presentation, Scott Bass, Esq., Sidley Austin LLP, gave the basics of AERs including when to submit, how long to maintain record and what constitutes a "serious AER."

Anthony L. Young, Kleinfeld, Kaplan and Becker LLP, followed, saying companies must investigate all product complaints and adverse events reported by consumers. He said the investigation must include all products in that batch and strict records need to be kept. He warned that in FDA inspections, AER files are often requested.

Michael Lelah, Ph.D., technical director, NOW Foods, explained his company's AER procedure, which  starts with receiving an AER, and  goes through the steps of: deciding if it's a serious AER, investigating the situation, reporting to FDA  and implementing a corrective/preventive action plan. (Check out this Image Gallery to see a tour of NOW Food's operations.)

Steve Swantek, president and CEO, PROSAR, noted the follow-up examination after an AER is just as important as submitting it to FDA. He said trend analysis can show an increase in frequency of adverse events, new supplement-drug interactions, and unexpected events associated with unlabeled or unintended use.

If AERs are a focus for FDA, as Fabricant said they are, then they should be a focus for supplement companies. Companies can't pretend like adverse events don't happen, and they have to report them, even if they don't agree with consumers' interpretation of the facts.

AERs are a part of GMPs (good manufacturing practices), and GMPs are the law.

For more information, check out what CRN's Steve Mister recently had to say about AERs in this INSIDER Q&A, or go to our sister site, SupplySide R&D Insights and check out the Report, "Delivering Safe, Innovative Supplements," by Rick Kingston, PharmD, president, regulatory and scientific affairs, SafetyCall International PLLC. Kingston goes in depth about AERs and explains best practices to ensuring AER policies are in line with FDA's expectations.

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