The Federal Trade Commission could be preparing to further scrutinize citizen petitions as an anti competitive practice in the pharmaceutical industry. Citizen petitions had previously not gotten as much attention as reverse payments, product hopping, or other types of anti competitive behaviors. But in February of this year, the FTC sued Shire ViroPharma over alleged abuse of the citizen petition process. Shire ViroPharma is a unit of Shire plc. That was the first time that the FTC sued over a citizen petition, but it could mark a change in behavior that the pharmaceutical industry would be forced to evaluate.
The FTC alleges that Shire ViroPharma filed several baseless citizen petitions in order to delay a generic version of its Vancocin D drug from reaching the market. The FTC’s lawsuit notes that the company filed “serial, repetitive, and unsupported filings” with the FDA. The FTC alleges that these citizen petitions costed consumers hundreds of millions of dollars by preventing them from having the generic option.
Michael A. Carrier, a Rutgers Law School professor and citizen petition researcher, said that the FTC has recognized the anti competitive behavior that citizen petitions could be inspiring and is moving to make it more difficult to file frivolous petitions. Shire ViroPharma had 46 filings, and the FTC believes that it has a strong case against the company.
Shire ViroPharma is expected to file a motion to dismiss, and the courts will have to decide whether to grant that motion as they consider the facts of the case. Companies such as Shire often retain regulatory law firms in order to fight antitrust charges.
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