MD Pharmaceuticals, Inc. v. Drug Enforcement Administration
United States Court of Appeals for the District of Columbia Circuit
133 F.3d 8 (1998)
- Written by Mary Phelan D'Isa, JD
Facts
In 1995, the Drug Enforcement Administration amended its regulations under the Controlled Substances Act (CSA) for certifying the registration process for Schedule II drug manufacturers. Under the amended regulations, a registered manufacturer retained the right to comment on another manufacturer’s application, but it did not retain the right to a hearing on an application other than their own. On the date the new regulations went into effect, Mallinckrodt Chemical, Inc. (MCI) requested approval from the Food and Drug Administration to withdraw two of its previous applications to register as a bulk manufacturer of methylphenidate, a generic version of the controlled substance Ritalin. On the same day, MCI submitted a new application to register as a bulk manufacturer of methylphenidate under the newly amended regulations. MD Pharmaceutical, Inc. (MDP), a current producer of methylphenidate, objected to MCI’s withdrawal of its previous applications, arguing that MCI was maneuvering to circumvent MDP’s right to demand a hearing under the old rules. Nonetheless, the DEA approved MCI’s withdrawal of its first two applications and eventually approved MCI’s registration as a producer of methylphenidate. MDP filed petitions for review in the Court of Appeals for the District of Columbia Circuit.
Rule of Law
Issue
Holding and Reasoning (Sentelle, J.)
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