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Biotech and Pharma

FTC loses Shire appeal, losing round in fight against citizen petition abuse

The Federal Trade Commission building in Washington
Source: Federal Trade Commission

An appeals court on Monday upheld a judge's decision dismissing a lawsuit filed by the U.S. Federal Trade Commission to fight the practice of brand-name drug companies using a government petition system to delay cheaper, generic drugs from coming to market.

The 3rd U.S. Circuit Court of Appeals ruled that a federal court in Delaware had been correct in dismissing the FTC's lawsuit against Shire. Shire was acquired by Takeda Pharmaceutical last month.

The agency had objected to ViroPharma, which Shire acquired in 2014, filing 46 "citizen petitions" and other filings between 2006 and 2012 to the U.S. Food and Drug Administration regarding generic equivalents to its antibiotic Vancocin HCl, on the grounds that it resulted in delayed sale of a generic version.

But while the appeals court acknowledged that the delayed entry meant "hundreds of millions of dollars in profits," it said that the petitioning activity had ceased and thus the company was not in violation of the law. This ruling agreed with what the lower court had said in March 2018.

The FTC said it "regrets the courts decision and is considering its options." Shire owner Takeda did not immediately respond to a request for comment.

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Key Points
  • The fine is related to Cambridge Analytica's improperly accessing the data of 87 million Facebook users.
  • If agreed upon, the fine would be the largest ever imposed by the FTC against a tech company.