RMMS Secures Copaxone® Win under Administrative Procedures Act

December 30, 2020 | Regulatory

RMMS recently secured a favorable decision on behalf of its client Sandoz, in connection with a complex regulatory action involving Teva’s blockbuster multiple sclerosis drug Copaxone® (glatiramer acetate).  Teva filed suit against FDA and the Department of Health and Human Services under the Administrative Procedures Act (APA) seeking to challenge FDA’s refusal to reclassify Copaxone as a “drug” regulated under the Food, Drug and Cosmetic Act (FDCA) to a “biological product” regulated under the Public Health Service Act (PHSA). More specifically, Teva claimed that the FDA’s requirement that a substance have a “specific, defined sequence” of amino acids to qualify as protein or as an analogous product was unreasonable and arbitrary and capricious.

RMMS intervened on behalf of FDA to protect Sandoz’s regulatory and commercial interests since such a reclassification likely would have eliminated automatic substitution of a glatiramer acetate generic and impose additional regulatory requirements to obtain approval as an interchangeable product.  U.S. District Chief Judge Beryl A. Howell agreed with RMMS, calling Teva’s lawsuit “yet another effort to stifle Copaxone competitors.”  She ultimately found FDA’s conclusion was in line with scientific definitions and granted summary judgment in favor of FDA, Sandoz and the other intervenor defendant.  Teva did not appeal the decision.

Members of the RMMS team representing Sandoz included William A. Rakoczy, Lara E. FitzSimmons, Trang H. Hoang and Rachel P. Waldron.