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U.S. District Judge Anita Brody Gives Green-light to Former FDA Chief David Kessler’s Testimony

In In Re: Flonase Antitrust Litigation pending in the Eastern District of Pennsylvania, U.S. District Judge Anita Brody rejected GlaxoSmithKline’s motion to exclude David Kessler’s testimony, ruling that his experience with the FDA made qualified him to render an opinion on whether the pharmaceutical company, as the plaintiffs allege, filed baseless petitions with the FDA in order to delay sales of a generic form of the blockbuster allergy medication.  David Kessler is the former chief of the FDA and is an expert in the Risperdal gynecomastia litigation currently pending in the Philadelphia Court of Common Pleas against Johnson & Johnson.

Judge Brody said “Kessler’s lifelong experience in the field of food and drug regulation demonstrates that he is well-equipped to discuss the FDA’s processes for responding to citizen petitions, and that he is qualified to opine on whether a sophisticated petitioner like GSK could have reasonably expected to succeed in changing FDA policy with its petitions.”

Classes of direct and indirect Flonase purchasers, as well as generic drug developer Roxane Laboratories Inc., have claimed in a series of lawsuits that GSK flooded FDA with sham citizen’s petitions shortly before its Flonase market exclusivity period expired.

Days before the FDA was set to approve Roxane’s ANDA for a generic version of Flonase, GSK began filing citizen petitions with the FDA to delay approval of any ANDAs for Flonase until the agency established guidelines to determine the bioequivalency of nasal spray products, the lawsuits allege. The FDA eventually rejected GSK’s petition and approved Roxane’s ANDA, according to court filings.

GSK has maintained that it cannot be held liable for antitrust violations under the so-called Noerr-Pennington doctrine, which grants First Amendment protection for parties that petition the government for redress. To bring a successful defense under Noerr-Pennington, however, petitioners must prove they had a reasonable chance of success in influencing government action. Plaintiffs in the case say Kessler can weigh in on whether GSK could have reasonably expected FDA to accept the positions laid out in its petitions.

While GSK argued that Kessler did not have the scientific expertise to comment on the particulars of its petition, the Court disagreed.

“These arguments fall flat. As a former commissioner of the FDA charged with overseeing the agency’s response to all citizen petitions, Kessler is qualified to opine on what move the FDA to adopt positions espoused in a citizen petition,” Judge Brody said. “Kessler testified that regulations surrounding ANDAs were ‘front burner at the agency when I got there,’ and that the approval of generic drugs occupied ‘a considerable amount of attention.’ Indeed, Kessler signed the extensive FDA regulations implementing the Hatch-Waxman Act, which revised the procedures for the approval of generic drugs; these regulations specifically covered citizen petitions as well.”

She also rejected the pharmaceutical company’s arguments that Kessler would merely repeat the same claims FDA made in rejecting GSK’s citizens petitions.

“His opinions … are based on his own analysis of GSK’s petitions and the agency’s responses, founded on the principle that only clinically meaningful data moves the FDA to change its policies,” she said. “In other words, Kessler is analyzing how the FDA made its determinations to demonstrate that a reasonably petitioner could not have reasonably expected the FDA to grant its petition.”

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