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Drug Price Hikes, Shortages Follow FDA Crackdown On Unapproved Drugs

 
• By Brenda Sandburg

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 approved background, 3D rendering, blue street sign

FDA's strategy for dealing with drugs marketed before the 1962 law requiring them to be proven efficacious may have led to an increase in drug prices and shortages, according to a study led by Yale University School of Medicine alumnus Ravi Gupta.

The researchers examined products that fell under FDA's 2006 Unapproved Drugs Initiative (UDI), which requires manufacturers of unapproved drugs to either obtain approval or remove them from the market. The agency provided an incentive for companies to voluntarily submit applications for unapproved drugs, saying it could give a shorter grace period to subsequent applicants before taking enforcement action, thereby giving the first company to obtain an approval "a period of de facto market exclusivity" before other products received approval

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