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A 2013 hepatitis outbreak linked to USPlabs’ OxyElite Pro supplement underscored the importance of FDA’s adverse event reporting system. However, an investigation into the series of events leading up to the recall of OxyElite Pro suggests there may be need for a more robust system to monitor and report adverse events.
A 2013 hepatitis outbreak linked to USPlabs’ OxyElite Pro supplement underscored the importance of FDA’s adverse event reporting system. However, an investigation into the series of events leading up to the recall of OxyElite Pro suggests there may be need for a more robust system to monitor and report adverse events.
In this episode, Josh Long, legal and regulatory editor, and Rachel Adams, managing editor, discuss:
FDA’s response to the 2013 hepatitis outbreak including threatened enforcement action against USPlabs;
Questions surrounding USPlabs’ role in reporting adverse events related to the outbreak;
Examples of the industry’s noncompliance with the legal requirement to report serious adverse events; and
The potential need for greater communication between regulatory agencies, dietary supplement manufacturers and others to improve the effectiveness of adverse event monitoring.
Links and Resources:
Hawaii Hepatitis Outbreak: Will DOJ Prosecute USPlabs?
Got feedback? Email Josh at [email protected] or Rachel at [email protected], or tweet to @NatProdINSIDER using the hashtag #INSIDERpodcast
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