FDA Chided for Delaying Tactics in Abilify Case; Agency Ordered to Supplement Record

The Food and Drug Administration must immediately supplement the administrative record in litigation challenging the agency’s decision to broaden an indication for the antipsychotic Abilify (aripiprazole), a federal trial court said April 8 (Otsuka Pharm. Co. v. Burwell, 2015 BL 99435, D. Md., 8:15-cv-00852-GJH, 4/8/15).

Chiding the FDA for its “dilatory tactics” in the case, Judge George J. Hazel of the U.S. District Court for the District of Maryland granted Otsuka Pharmaceutical Co.'s emergency motion to compel the FDA to immediately file the complete administrative record in the case.

Hazel found that Otsuka had overcome the “strong ...