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, ViroPharma filed 24 citizen petitions with the FDA to delay the approval of generic versions of Vancocin, 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 first approved in 1986.
In 2007, Mutual Pharmaceuticals filed a petition raising concerns about other generic manufacturers’ versions of the blood pressure drug Plendil. The petition asked the FDA to determine what type of orange juice had been used in studies analyzing its interactions with the drug. Seville oranges, which are more bitter, might have different effects than regular orange juice.
In 2015, about a year before EpiPen prices created a public firestorm, Mylan filed a petition alleging that a generic version of the EpiPen in the works had a 93 percent failure rate. Mylan commissioned the study that came up with statistic, which an outside expert called “flawed from start to finish.”