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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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More from US FDA

US FDA Could Miss User Fee Spending Triggers With House FY 2026 Funding

 
• By Sarah Karlin-Smith and Derrick Gingery

FDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user free appropriations' triggers, the FDA could have trouble meeting allocation triggers without cuts to non-review work.

US FDA May Consolidate Support Services After Extensive Cuts

 
• By Derrick Gingery and Sue Sutter

Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.

US FDA’s Rising First-Cycle Complete Response Rate Draws Congress’ Attention

 
• By Sue Sutter

The House Appropriations Committee wants an analysis of how issues that led to CRLs could have been resolved within the first review cycle and seeks an agency crackdown on counterfeit GLP-1 agonists.

ACIP Upheaval Leaves Merck & Co. In A Lurch

 
• By Jessica Merrill and Bridget Silverman

Merck’s newly approved Enflonsia for RSV is one of the products expected to be recommended for use by the CDC Advisory Committee on Immunization Practices later this month.

More from Agency Leadership

US FDA Chief Counsel Position Awaits HHS General Counsel Confirmation

 
• By Sue Sutter

Robert Foster, HHS deputy general counsel and chief counsel for food, research and drugs, is temporarily heading the Office of Chief Counsel, but a permanent appointee is expected after Michael Stuart's confirmation as HHS general counsel.

HHS Secretary Favors Regenerative Medicine Over Traditional Pharma: Blessing And Curse?

 
• By Sarah Karlin-Smith

Cell and gene therapy developers may not have to contend with HHS Secretary Robert F. Kennedy Jr.’s animosity like the traditional pharma industry, but his disinterest in distinguishing between the good and bad actors in the space could backfire.

Generic Drug Office’s Policy Staff Returning To US FDA

 
• By Derrick Gingery

The group had been laid off as part of the 1 April reduction-in-force, which led to missed guidance publication deadlines.