Citizen's petition: Is it a plea for patient safety or a tactic to protect profits?

A "citizen petition" sounds so wonderfully basic. It sounds like one person asking her or his government to consider a matter of public policy, health and safety.

And sometimes that's what they are.

And sometimes a citizen petition is a tool for corporations to try to gain an edge in the regulatory world, and thus the marketplace, of pharmaceuticals, through rulings by the U.S. Food and Drug Administration - or the delays that such actions create.

A multi-year dispute, involving citizen petitions and lawsuits, between GlaxoSmithKline and Roxane Laboratories how long GSK could keep the market to itself for a steroid nasal spray called Flonase is in federal court in Philadelphia. GSK filed citizens petitions questioning the safety and efficacy of Roxane's version of the drug.

A link to an Inquirer story on the case is here.

Rutgers-Camden law professor Michael A. Carrier recently coauthored a paper on the topic and a link to that is here.

The case combines antitrust law and FDA rules, with some of the debate about how they conflict.

Part of GSK'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.

District Court Judge Anita Brody ruled the other day that former FDA Commissioner David Kessler could testify for Roxane because Kessler's testimony "is directly related to the question of sham petitioning."

This is not the first corporate court fight on this issue. But the branded-drug pharmaceutical trade group, the Pharmaceutical Research and Manufacturers of America cautioned in April that more court fights could occur unless the FDA can provide opportunity for - and clarify how it will judge - challenges to the safety and efficacy of generic drug applications.

"FDA’s policy may encourage petitioners to forgo the citizen petition process altogether and instead challenge FDA’s policies and approval standards directly in court," PhRMA said in an April letter to the FDA about its proposed changes to rules about citizen petitions. "This option may appear more attractive because, under FDA’s policy, the filing of a petition in many, if not most, cases will be futile. However, it likely will result in unpredictable remands to the agency, extended delays in approval for [generic applications], and (in cases without a remand) the loss of FDA’s expertise on important scientific, medical and legal issues affecting generic drug approval standards. FDA’s policy thus conflicts not only with the statute but also with sound public policy interests."