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The US FDA Acts To Bolster Adverse Event Reporting For Compounded Drugs

 
• By Joanne S. Eglovitch

After discovering one firm suppressed over 4,000 compounded-hormone adverse event reports, agency leans on compounders and outsourcers to improve reporting.

Clipboard with medical form and sign Hormone Replacement Therapy. - Image
FDA Wants Drug Compounding Pharmacies To Up Their Adverse Reporting Game • Source: Shutterstock

The US Food and Drug Administration is taking steps to improve the reporting of adverse events with compounded drugs, and aims to finalize a memorandum of understanding with states agreeable to reporting such events to the FDA when they occur at state-regulated compounding pharmacies.

This action was prompted by a recent case involving BioTE Medical, which suppressed 4,202 adverse events over a five-year period involving compounded hormones it was marketing; the firm chose not to share these reports with the outsourcing facilities that compounded them nor with the agency

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US FDA Expands Surprise Foreign Inspections But Loses Associate Commissioner Michael Rogers

 
• By Sue Sutter

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Pharma Predicts Modest Tariff Impact, Depending On What Comes Next

 
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Aragen’s CEO Says NIH Funding Cut Means Less R&D Money, And Tariffs Would Add To Woes

 
• By Vibha Ravi

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US FDA Retirements Continue Unabated With Drug Inspectorate Leaders, Former Chief Counsel

 
• By Sue Sutter and Derrick Gingery

Alonza Cruse, director of the Office of Human and Animal Drugs Inspectorate, and two other senior inspection officials are departing, along with Mark Raza, chief counsel from 2021 until January.

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