Serono files Pergonal suit against FDA to reverse approval of Ferring generic menotropins.

SERONO MENOTROPINS SUIT DEMANDS REVERSAL OF FERRING ANDA APPROVAL for a generic version of Pergonal. Serono v. Shalala and Friedman was filed by Serono attorneys Fox Bennett & Turner in Washington, D.C. District Court on May 30. The suit alleges that "FDA relied on Serono's injectable menotropins product for infertility -- Pergonal -- in approving the Ferring ANDA, even though the active and inactive ingredients in Pergonal are different from the ingredients in the Ferring generic product." FDA approved the Ferring NDA on Jan. 30.

FDA found differences between the Ferring generic product and Serono's Pergonal, the suit states. As evidence, Serono cites an October 1996 statement of FDA's Division of Metabolism and Endocrine Drug Products that "from a chemistry viewpoint, the firm [Ferring] has not provided adequate information to show that the active ingredients of the two drugs are the same as required by 21 CFR 319.94 (a)(5)(B)(ii). Therefore, with respect to the chemistry, manufacturing and controls information for the drug substance...this application is recommended as not approvable." Consequently, the Serono complaint concludes, "FDA devised alternative standards that do not appear in the [Federal Food, Drug & Cosmetic Act] or the agency's implementing regulations and which are inconsistent with the legally applicable requirements."

Ferring responded June 5 that the Serono lawsuit is "totally without merit." Ferring said it "is not surprised by Serono's action against the FDA and views this as a tactic used by many companies trying to delay or block a new entry to the market."

"The arguments addressed in the lawsuit do not vary from those presented in a 1992 citizen's petition filed by Serono and were addressed as part of the regulatory review process," Ferring stated. The Serono complaint maintains that FDA never responded to its 1992 citizen's petition requesting the agency to withhold approval of menotropins ANDAs.

Serono also argues that "the unique nature of each menotropins product and the differences among both the active and inactive ingredients of various menotropins products has caused FDA previously to take the position that a generic menotropins could not be approved under the ANDA" approval process.

"FDA officials have acknowledged in discussions with Serono representatives that menotropins is essentially a biologic product," according to the suit. "FDA has not approved a `generic biologic' because the different processes utilized by various companies to manufacture a biologic necessarily result in different products....Despite the similarity of menotropins products to products regulated by FDA as biologics because of their inherent variability, FDA has chosen to regulate Pergonal as a drug for the purposes of regulatory approval of other menotropins products," the complaint states. FDA required Organon to file a full NDA, not an ANDA, for its menotropins product Humegon, Serono notes; the Humegon NDA was approved Sept. 1, 1994 ("The Pink Sheet" Sept. 12, 1994, T&G-6).