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Missing Data: One Long-Term Lesson From US FDA Action On Hydroxychloroquine

 
• By Michael McCaughan

Politicization of COVID-19 treatments is one of the unexpected wrinkles amid an unprecedented pandemic. But one lesson from the hydroxychloroquine experience in the US is more typical if still troubling: almost no one followed the rules on reporting follow-up data.

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The US Food and Drug Administration’s handling of the authorization allowing emergency use of hydroxychloroquine and chloroquine for treatment of COVID-19 will inevitably be viewed as a test of the agency’s independence in the context of the Trump Administration.

The 15 June revocation of the EUA granted for the products will certainly weigh heavily in favor of FDA’s independence and credibility, though critics of the agency will continue to argue that the use should never have been authorized in the first place

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Opioid Safety: US FDA Hears Mixed Messages On Adding Posmarketing Studies To Labeling

 
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Some advisory committee members said adding quantitative data on misuse, abuse, opioid use disorder and overdose to labeling would be helpful, but others worried the two epidemiological studies were not sufficiently generalizable to a broader population.

Updated: Makary Backs New Novavax COVID-19 Trial, Political Officials Take Over Product Review

 
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Pink Sheet Podcast: More US FDA Departures, Makary On Combined AE Database, ‘Conditional’ Approval

 
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Pink Sheet reporter and editors discuss the most recent senior staff departures at the FDA and their impact on the agency, as well as Commissioner Martin Makary’s plans for a new approval pathway and a combined adverse event database as outlined in an interview with a podcast host.

US FDA Commissioner Makary Wants To Combine Adverse Event Reporting Systems

 
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In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.

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FDA Adcomms Are Back: Four Cancer Drugs, COVID-19 Vaccine Formulations To Get Reviews

 
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The Oncologic Drugs Advisory Committee will meet for two days in mid-May, followed by a Vaccines and Related Biological Products Advisory Committee’s review of the 2025-2026 COVID-19 vaccine formulation.

Unlocking Opportunities: How To Engage With The EMA On Animal Testing Alternatives

 
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Opioid Safety: US FDA Hears Mixed Messages On Adding Posmarketing Studies To Labeling

 
• By Sue Sutter

Some advisory committee members said adding quantitative data on misuse, abuse, opioid use disorder and overdose to labeling would be helpful, but others worried the two epidemiological studies were not sufficiently generalizable to a broader population.