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Orphan Drug Designation For Remdesivir Is 'Consistent' With Precedent, Former FDA Lawyer Says

 
• By Brenda Sandburg

Attorney who drafted Orphan Drug Act implementing regs says companies need incentive to develop a treatment that may not be available until crisis passes; KEI is mulling citizen petition to request revocation of the designation for Gilead's investigational COVID-19 product.

Vaccine bottle design related to viruses cures. Illustration design medical healing.
Gilead's remdesivir receives orphan drug designation for COVID-19

The US Food and Drug Administration's decision to grant orphan drug designation to Gilead Sciences Inc.'s remdesivir for COVID-19 has raised questions about whether the award should be given when the treatment population is expected to surpass the orphan limit of 200,000 in the US.

But Frank Sasinowski, former deputy director of health policy staff at FDA who drafted the Orphan Drug Act's implementing regulations,...

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