How Pharma Companies Use 'Citizen Petitions' to Keep Drug Prices High

In theory, citizen petitions about drug safety are supposed to be exactly what they sound like: a way for anyone to bring concerns straight to the Food and Drug Administration.

In practice, many citizen petitions are filed by none other than pharmaceutical companies themselves—as a way of fighting off a competitor’s cheaper generic drug. The concerns raised, according to a New England Journal of Medicine study of 12 years of such petitions, are often “frivolous or questionable,” no more than a “last-ditch effort to hold off competition.” The FDA takes months to respond to the petitions, which have gotten lengthier and more frequent over the past decade.  

Consider a few examples:

• Between 2006 and 2012,, an antibiotic. That was in addition to  its 18 public comments, a new drug application supplement, and three lawsuits against the FDA—all over a drug .