> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FTC Expanding Enforcement Theories: Legal Analysis
- URL: https://www.fdaweb.com/ftc-expanding-enforcement-theories-legal-analysis/
- Published: 2017-10-17T12:00:00.000Z
- Updated: 2026-09-14T22:56:26.000Z
- Author: David McFarland
- Tags: Drugs, FDA Policy/General, #legacy-id-D5139895

Three Gibson, Dunn & Crutcher attorneys write in a *WLF Legal Pulse* published by Washington Legal Foundation that a Federal Trade Commission (FTC) suit against Shire is the latest development in the FTC’s well-established program for enforcing antitrust laws where it feels generic competition is being blocked or delayed. The Shire case involves a suit filed by the FTC in Delaware federal court alleging that the company violated antitrust laws by filing sham citizen petitions to slow or block generic competition for its Vancocin.

A Shire campaign to overturn an FDA change in policy that permitted generic drug applicants to demonstrate bioequivalence with Vancocin through *in vitro* testing rather than requiring *in vivo* tests included 24 citizen petitions and 18 public comments between 2006 and 2012, along with three lawsuits and an sNDA, the post says. FDA rejected Shire’s petition 4/2012, denied its procedural challenges, and approved applications for generic Vancocin capsules.

FTC said the Shire petitions and other filings were “repetitive, serial, and meritless” and “lack\[ing\] any supporting clinical data.” The agency says the petitions were the most filings ever made to FDA by a single company about a drug product. FTC also cites FDA’s conclusion that Shire’s campaign was an improper use of the citizen petition process and that the timing of the company’s filings suggests that the company’s conduct was improper.

Shire filed a motion to dismiss the FTC complaint, the attorneys write, arguing that its actions are protected by the so-called Noerr-Pennington doctrine that is grounded in the First Amendment and exempts a party from liability for petitioning activities, including bringing suit, unless the activities are shown to be a “sham.”

Generally, the analysis says, a party challenging petitioning activities must show that they are: **(1)** objectively baseless, such that no reasonable litigant could realistically expect success on the merits; and **(2)** subjectively motivated by an intention to interfere directly with a competitor’s business, rather than a genuine interest in the outcome.

According to Shire, its 24 petitions were constituent parts of one single petition advocating that FDA maintain the same standard for evaluating bioequivalence that it had previously employed for a decade. Shire also said that FDA had evaluated the company’s filings for six years, modified its policy position, inviting public comment, and convened two advisory committees to evaluate the issues the company raised. It said that any delay in approving generic versions of Vancocin came from the agency taking the time necessary to consider the complex scientific issue surrounding the bioequivalence standard.

FTC countered that because FDA must respond to each petition individually, the company’s 24 petitions were separate filings. The agency also says that its allegations concerning Shire’s lack of clinical data and the comprehensive rejection of the company’s petitions suffice to show objective baselessness at the pleading stage of the case.

The attorneys say that a decision on Shire’s motion to dismiss has been pending since June. The company has requested oral argument on its motion, but the court has not scheduled or held a hearing.

“*FTC v. Shire ViroPharma* represents the first instance where FTC has pursued antitrust allegations against a drug manufacturer based solely on submissions petitioning FDA,” the attorneys conclude. “But the action follows a series of signs that FTC likely would target enforcement resources toward such conduct.” They note that when the Shire case was filed, FTC acting chair **Maureen Ohlhausen** said that, “When we have reason to believe that a branded drug company misuses government processes to unlawfully maintain a monopoly by delaying generic entry, FTC will act to protect competition.” They say they view her comment “as signaling that the Shire case is not a one-off action, but rather a careful expansion of FTC’s broader effort to regulate the line between permitted versus potentially anticompetitive conduct in the pharmaceutical sector.”