The Food and Drug Administration is taking steps to prevent brand name drugmakers from organizing citizen petitions aimed at delaying approval of generic competition, which the agency says is unnecessarily bogging it down with meritless petitions.
FDA Commissioner Scott Gottlieb announced new regulatory guidance on Tuesday as part of a broader effort to crack down on practices that officials say brand name drugmakers use to stifle competition.
Gottlieb said in a statement that the FDA will consider a range of factors to determine whether a petition is submitted with the "primary purpose of delaying the approval of a generic drug application."
“If the agency determines that this is the case, the FDA will consider whether the petition can be denied on that basis,” he said.
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The agency will also publicly highlight the petitions it deems are being used to delay generic competition in the hopes of shaming companies from employing the tactic.
Gottlieb said that “while the record shows that citizen petitions have rarely delayed specific generic drug approvals, there’s no doubt that the process requirements associated with … petitions can add to resource burdens on the generic drug review process.”
The Federal Trade Commission has already targeted some drugmakers for the tactic. For instance, from 2006 to 2012, the company Shire ViroPharma made 43 filings with the FDA and filed three lawsuits seeking to stop a generic version of its antibiotic Vancocin HCI capsules. The FTC filed a complaint in federal court last year charging Shire ViroPharma with “abusing government processes to delay generic competition.”
It charged that the number and frequency of the company’s petitions were “many multiples beyond that by any drug company related to any drug."
The FDA recently called out drugmakers for withholding samples from generic companies that they need to win FDA approvals.
A generic company needs up to 5,000 samples of a brand name drug to complete approval testing, but sometimes a brand drug company will not give the samples and cite an FDA safety strategy called Risk Evaluation Mitigation Strategy. The strategy sometimes calls for limiting distribution of certain drugs to patients, but that limit does not apply to generic drugs.