US FDA’s Unapproved Drug Initiative Nixed, But Without Agency Buy-In Demise May Be Short-Lived
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.
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A surprise move to unwind FDA’s efforts to end the marketing of unapproved drugs is in keeping with the overall sense of the top-down intervention in the agency’s policies at the end of the Trump Administration. It is also an unfortunate consequence of the embrace of drug pricing as part of FDA’s mission.
Study finds unintended consequences of FDA initiative requiring manufacturers of unapproved drugs to obtain approval or remove them from the market but FDA says study does not consider broad impact of the initiative.
FDA is drawing a line in the sand when it comes to unapproved drugs, and that line begins at Sept. 19, 2011.