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US FDA’s Unapproved Drug Initiative Nixed, But Without Agency Buy-In Demise May Be Short-Lived

 
• By Sarah Karlin-Smith

Trump administration effort to reduce drug prices by curtailing agency program requiring new approvals for some old products undermines FDA’s role in policing the safety of prescription drugs, experts say.

Conceptual hand writing showing FDA Approved.
HHS halts FDA program that encourages marketing approval of old drugs • Source: Shutterstock

The US Department of Health and Human Services is ending the Food and Drug Administration’s Unapproved Drugs Initiative in an effort to tackle the cost of prescription drugs, arguing the program has led to spikes in drug prices and shortages.

The administration is also considering whether more drugs should be exempt from FDA’s approval process – a move that could...

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