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    How Drug Companies use Loopholes to Delay Generic Drug Approvals

    The citizens petition process is being used to delay approval of generic drugs.


    In the 1970s the FDA introduced a citizen-petition process into its generic approvals to make them safer. But new research has shown that this process is being used by drug companies to delay approval of generic drugs.

    A study, published March 1 in The New England Journal of Medicine, and forthcoming in the Stanford Technology Law Review, analyzed all citizen petitions filed between 2000 and 2012. It found “widespread, strategic use of the citizen-petition pathway by drug companies striving to hold off competition.”

    The petitions request more investigation or data about a drug, and can either delay the approval of a generic version of a branded drug or prevent it entirely. Nearly half of the petitions studied were filed within the year and a half before the FDA approval of a generic. A large number, 40%, were filed less than a year before the approval. The number of these delay-related petitions has more than doubled since 2003.


    Although it is possible that these late petitions were filed because of information found late in a drug’s approval process, the FDA has said that most of them “contained data that had been available to the petitioner well before the date of the petition.” The study authors concluded that drug companies are using these petitions as a delaying tactic.

    The authors note that many petitions raised real concerns. They cited a 2003 case in which Wyeth Pharmaceuticals argued that a lack of labeling in generic versions of its immunosuppressant Rapamune (sirolimus) created safety concerns. The FDA agreed on this point.

    Related article: Generics and biosimilars, key to Trump drug price concerns

    But the authors found that these legitimate cases “appear to be the exception rather than the rule.” For example, Mutual Pharmaceuticals drafted a petition to delay generic versions of its antihypertensive Plendil (felodipine). The concern was whether drinking juice from Seville oranges, which are bitter and rarely used for juice, affected absorption. The FDA denied the petition, citing a lack of evidence from Mutual.

    In another example, on the day before a generic version of its antibiotic Doryx (doxycycline) was to be approved, Warner Chilcott started marketing the tablets with two score lines instead of one, and asked that all generic versions of the drug do the same. The FDA said it could find no safety concerns regarding a single-score tablet, denied the petition immediately, and approved the generic.

    Up next: The future of citizen petitions


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