agency, by the mere issuance of a regulation, could modify these mandated channels of distribution. Accordingly, the Court concludes that FDA has overstepped the bounds of its authority in purporting to limit the distribution of methadone in the manner contemplated by its regulations.
It is undoubtedly true that methadone poses unique problems of medical judgment, law enforcement and public policy but this fact alone cannot justify a federal agency of specifically delimited jurisdiction from implementing equally unique control solutions not authorized by Congress. The problem of unlawful diversion is one presently consigned by Congress to the Drug Enforcement Administration (DEA, formerly the Bureau of Narcotics and Dangerous Drugs) of the Department of Justice. FDA, on the other hand, has the responsibility of making the initial decision, based on all available medical and scientific data, as to whether a particular new drug is safe and effective for its intended use. While the functions of FDA and DEA are not entirely exclusive of one another,
a certain division of authority and responsibility was clearly intended by Congress and must be recognized by this Court in order to preserve the integrity of the legislative scheme. Under these circumstances, the relative merits of FDA's plan to control the distribution of methadone, a controlled substance, must first be passed upon by Congress.
Wherefore, for all the foregoing reasons, it is this 5th day of June, 1974,
Ordered, that plaintiffs' motion for summary judgment be, and the same hereby is, granted; and it is
Further ordered, that defendants' motion to dismiss, or in the alternative, for summary judgment be, and the same hereby is, denied.
Order to be settled on notice.