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Firms' Use of Citizen Petitions Against Generics Debated

Firms' Use of Citizen Petitions Against Generics Debated [the Philadelphia Inquirer]

From Philadelphia Inquirer (PA) (November 6, 2012)

Nov. 06--Is it a plea for patient safety or a tactic to protect profits? Such is the pharmaceutical industry debate around so-called citizen petitions filed with the U.S. Food and Drug Administration.

Lone citizens and patient advocacy groups can and do submit such petitions, raising safety or effectiveness issues about drugs.

But this debate is about brand-name drug makers that file petitions challenging generic competitors, and about those competitors filing petitions against new versions of previously approved brand-name drugs. Both sides argue that they are on the side of consumers.

GlaxoSmithKline P.L.C., which has a big presence in the Philadelphia area, is among the brand-name drug makers trying to fend off generic competitors in several ways, including the use of citizen petitions.

For three years, Glaxo has fought a suit in federal court in Philadelphia that mixes antitrust law with First Amendment rights and a dash of FDA regulation.

In the case, generic maker Roxane Laboratories sued Glaxo on antitrust grounds, after Glaxo filed a citizen petition challenging Roxane’s version of Glaxo’s steroid nasal spray, Flonase.

Glaxo’s defense in the case took a hit late last week when U.S. District Judge Anita B. Brody ruled that former FDA Commissioner David Kessler could testify for the plaintiffs in front of a jury in the case against Glaxo.

"Citizen petitions are consistent with the First Amendment right to petition the government, and even large companies have that right," said Rutgers-Camden law professor Michael A. Carrier, who coauthored a recent paper on the topic. "They do raise concerns that the FDA should know about. But a lot of petitions are filed by large companies in an effort to delay generic entry into the market."

The FDA’s main function is testing the safety of food and drugs, so the agency will examine such petitions. It was only in 2007 that Congress specifically said the FDA does not have to delay a generic drug approval request until a citizen petition is resolved.

At its height in 2005, Flonase had $1.3 billion in sales.

In May 2004, Glaxo filed the first of several citizen petitions against Roxane’s version of Flonase and sued when the FDA rejected the first petition in 2006.

Ohio-based Roxane sued Glaxo in 2009, arguing that Glaxo’s petitions and lawsuit were merely delaying tactics.

A Glaxo spokeswoman said: "We will continue to defend this matter."

Part of Glaxo’s First Amendment defense is the Noerr-Pennington legal doctrine, which stems from two Supreme Court cases and says that a party petitioning the government is immune from antitrust liability.

But an exception to that doctrine is when the conduct is judged to be a "sham," intended only to delay a competitor. Kessler’s testimony, Brody wrote, "is directly related to the question of sham petitioning."

Contact staff writer David Sell at dsell@ or 215-854-4506. Read his blog at and on Twitter @phillypharma.


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Posted: November 2012