Amgen Inc. v. Azar
United States District Court for the District of Columbia
290 F. Supp. 3d 65 (2018)
- Written by Philip Glass, JD
Facts
Amgen Inc. (plaintiff) applied for six months of pediatric exclusivity for its drug Sensipar. In response, the Food and Drug Administration (FDA) provided Amgen with a written request for clinical studies in support of Amgen’s pediatric-exclusivity application, which Amgen then completed and submitted. However, the FDA determined that the studies Amgen submitted did not fairly respond to the written request’s conditions, as required under the pediatric-exclusivity statute, 21 U.S.C. § 355a(d)(4). Although the FDA required that Amgen conduct studies involving at least 15 subjects, only four subjects had completed one of the studies. Notably, the FDA had previously granted pediatric exclusivity for Johnson & Johnson’s drug Ortho Tri-Cyclen. Although Johnson & Johnson satisfied the FDA’s request that studies include at least 120 subjects, an expert determined over a year later that most of the subjects failed to satisfy the anorexia nervosa diagnostic criteria contained in the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV). On these grounds, Amgen claimed that the FDA acted arbitrarily and capriciously in refusing to grant pediatric exclusivity to Sensipar while granting it to Johnson & Johnson.
Rule of Law
Issue
Holding and Reasoning (Moss, J.)
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