A citizen’s pathway gone astray — delaying competition from generic drugs

New England Journal of Medicine

1 March 2017 - Many medicines are making headlines these days not for their breathtaking ability to save lives, but for their soaring prices. 

Part of the problem occurs because pharmaceutical companies have become adept at converting regulatory pathways into vehicles for profit-boosting pricing strategies. Consider the citizen-petition process that the FDA implemented in the 1970s to give the average citizen a way to voice concerns. 

A recent large-scale study we conducted using 12 years of FDA data reveals that the concerned citizen is frequently a drug company raising frivolous or questionable claims in a last-ditch effort to hold off competition.

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Michael Wonder

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Michael Wonder