Court Dismisses FTC’s Citizen Petition Complaint Against Shire

Regulatory NewsRegulatory News | 26 March 2018 |  By 

Delaware’s District Court late last week dismissed the Federal Trade Commission’s (FTC) complaint against Shire’s citizen petitions, but the court also left the door open for FTC to amend its complaint.

In February 2017, FTC filed a complaint against Shire ViroPharma, for filing 46 citizen petitions with the US Food and Drug Administration (FDA) to try to block or delay the marketing of generic versions of its antibiotic Vancocin (vancomycin).

“That number is, by far, the most filings that any firm has ever made to the FDA concerning a single drug product,” FTC said in its complaint.

But the District Court’s judge wrote in the dismissal: “I do not think these allegations, without more, plausibly suggest ViroPharma is ‘about to violate’ any law enforced by the FTC, particularly when the alleged misconduct ceased almost five years before filing of the complaint.”

But the judge also allowed the FTC to amend its complaint.

According to the FDA Law Blog, the court’s ruling “is not immediately appealable, because the Court dismissed without prejudice and gave the FTC leave to amend its complaint.

“The Court even provided some guidance to the FTC in amending the complaint, by suggesting that facts about another Shire drug discussed at oral argument, but which did not appear in the complaint, might satisfy the ‘about to violate’ requirements ... Alternatively, the FTC could take steps to pursue an appeal, such as moving the District Court to certify the legal issue for appeal pursuant to 28 U.S.C. § 1292(b) and stay the case pending review by the Third Circuit.  Given the high stakes, we would not be surprised if the FTC chose this latter option.”

The blog also noted that if the District Court’s “statutory interpretation is accepted more broadly, it would significantly limit a statutory mechanism that the FTC has used extensively to seek injunctive and other relief in both antitrust and consumer protection actions since the 1980s.” 

Both the FTC and Shire told Focus they have no comment at this time.

Delaware District Court Order


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