The Digital Magazine “AER Reporting in OxyElite Pro Hepatitis Outbreak: What Dietary Supplement Industry Can Learn” examined USPlabs Inc., a manufacturer of dietary supplements tied to an outbreak of hepatitis and liver illnesses in Hawaii, how a Food and Drug Administration (FDA) adverse event reporting (AER) system played a role in the investigation of the reported illnesses by state health officials and federal authorities, and the fallout from the investigation.
In 2013, a number of Hawaiians who took the weight-loss supplement OxyElite Pro began falling ill with liver failure, triggering an investigation by state and federal authorities and ultimately, prompting the manufacturer to recall its products in the face of threats from FDA.
Under a 2006 law, dietary supplement distributors and manufacturers must inform FDA of serious adverse events such as a death or hospitalization potentially linked to their products. Consumers, physicians and others also have the option of reporting adverse events through the FDA Adverse Event Reporting System (FAERS). Through interviews and a review of FDA documents and third-party research investigating the 2013 outbreak, INSIDER explored the role of the FAERS and its limitations in prompting federal authorities to act. INSIDER also examined the legal authority that FDA invoked to remove OxyElite Pro from the market, how the manufacturer of OxyElite Pro responded, and the fallout from the investigation including a criminal indictment pending against USPlabs.
Separately, three industry experts comprised of a former FDA regulator, an attorney and an AER expert weighed in on the role of serious adverse event reports in the outbreak—including its limitations in establishing the actual cause of the reported illnesses—and offered recommendations to improve the system.
This Digital Magazine was recognized as an honorable mention in the B2B Standalone Digital Magazine – Construction/Manufacturing category from Folio: Magazine this year.
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