1. Pink Sheet

Email Trove From US FDA Shows Peter Marks As Champion For Plasma Authorization

 
• By Sarah Karlin-Smith

The emergency use authorization for convalescent plasma in August 2020 on weak data from an expanded access program has largely been viewed as a politically charged decision by the Trump administration. But newly revealed emails from the run up to the decision indicate Center for Biologics Evaluation and Research Director Peter Marks backed the plan.

FDA’s authorization of convalescent plasma has been one of the agency’s most controversial decisions during COVID-19 • Source: Nielsen Hobbs for Informa| Alamy, FDA images

Newly available internal emails from the US Food and Drug Administration reveal that senior career scientists may have played a larger role in pushing through the emergency use authorization for convalescent plasma to treat COVID-19 patients than was widely believed at the time.

The August 2020 EUA was made public in a dramatic White House press conference featuring then President Donald Trump, his Health and Human Services Secretary Alex Azar and and FDA Commissioner Stephen Hahn. The rollout was filled with hype and misleading data that overpromised on the likely benefits of the treatment

More from Agency Leadership

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Recent and Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 
• By Anabel Costa-Ferreira

Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.

EU Health Data Space May Speed Up R&D Through Access To Multi-Omics & Clinical Record Data

 
• By Eliza Slawther

The European Health Data Space framework will allow companies to accelerate R&D processes and identify new molecular targets faster by facilitating centralized access to certain types of high-quality data, Finland’s Orion Pharma says.