US FDA’s Unapproved Drug Initiative Nixed, But Without Agency Buy-In Demise May Be Short-Lived
Executive Summary
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.
You may also be interested in...
US FDA’s Unapproved Drugs Initiative Comes Back To Life, With New Enforcement Guidance On Its Way
Longstanding compliance policy program aimed at getting marketed but unapproved drugs through the NDA/ANDA pathway is reinstated because its termination by the Trump Administration was ‘legally and factually inaccurate’; some experts want FDA to consider program’s impact on drug pricing as it re-establishes the initiative.
‘Legacy’ Drugs And Former US FDA Commissioner Gottlieb’s Legacy
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.
Drug Price Hikes, Shortages Follow FDA Crackdown On Unapproved Drugs
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.