Accord suing Acorda for Ampyra samples

Generics company Accord Healthcare Inc. (Durham, N.C.) filed suit in the U.S. District Court for the Southern District of Florida against Acorda Therapeutics Inc. (NASDAQ:ACOR) alleging Acorda is violating antitrust laws by refusing to provide samples of Ampyra dalfampridine for bioequivalence testing. Accord is developing a generic version of the drug, which is approved to improve walking ability in multiple sclerosis (MS) patients, and said Acorda's refusal to provide Ampyra samples has delayed Accord from developing and bringing to market a generic version of Ampyra. Accord is seeking an injunction requiring Acorda to immediately provide Ampyra samples to the generics company, plus damages.

Acorda said it is "under no legal obligation to fulfill Accord's purchase request and declines to do so." The company also said Accord's purchase would not be in line with Ampyra's REMS, which requires that prescribers be advised of the potential risks of using Ampyra. Additionally, Acorda noted that Congress chose not to amend the Food, Drug and Cosmetic Act (FDCA) to include a provision requiring NDA holders to provide product to generic applicants for bioequivalence testing. The generics company said Congress did include a provision prohibiting NDA holders from using REMS "to block or delay approval of" an ANDA. ...