A Citizen’s Pathway Gone Astray –Delaying Competition from Generic Drugs

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In a commentary in the New England Journal of Medicine, Robin Feldman and Connie Wang write that pharmaceutical companies have become adept at converting regulatory pathways into vehicles for profit-boosting strategies.  They study the “citizen-petition process” that the Food and Drug Administration implemented in the 1970s to give the average citizen a way to voice concerns.  Using 12 years of FDA data, they found that the “concerned citizen” is frequently a drug company raising frivolous or questionable claims in a last-ditch effort to hold off competition.