Group of 37 individual drug manufacturers bring action
The present action was brought by a group of 37 individual drug
manufacturers and by the Pharmaceutical Manufacturers
Association, of which all the petitioner companies are members,
and which includes manufacturers of more than
90% of the Nation's supply of
Claim Commissioner Exceeded his Authority
They challenged the regulations on the ground that the
Commissioner exceeded his authority
under the statute by promulgating an order requiring
labels, advertisements, and other printed matter relating to
prescription drugs to designate the established name of the
particular drug involved every time its trade name is used
anywhere in such material.
Injunctive and Declaratory judgment are discretionary
Injunctive and declaratory judgment remedies are discretionary,
and courts traditionally have been reluctant to apply them to
unless these arise in the
context of a controversy "ripe" for judicial resolution.
Basic Rationale of Ripeness
The basic rationale of the ripeness doctrine is to
prevent the courts, through
avoidance of premature adjudication, (1)
from entangling themselves in abstract
disagreements over administrative policies, and also
(2) to protect the agencies from
judicial interference until an administrative
decision has been formalized and its (3)
effects felt in a concrete
way by the challenging parties.
Fitness of the issues for judicial decision
The hardship to the parties of withholding court consideration.
Fitness of the issues
We believe the issues presented are appropriate for judicial
Whether the statute was properly construed by the Commissioner
to require the established name of the drug to be used every
time the proprietary name is employed?
Impact or regulations
The impact of the regulations upon the petitioners is
sufficiently direct and immediate as to render the issue
appropriate for judicial review at this stage.
Puts petitioners in a dilemma
Its promulgation puts petitioners in a dilemma that it was the
very purpose of the Declaratory Judgment Act to ameliorate
District Court Findings
"Either they must comply with the every time requirement and
incur the costs of changing over their promotional material and
labeling or they must follow their present course and risk
Immediate compliance with their terms was expected.
If petitioners wish to comply they must change all their labels,
advertisements, and promotional materials;
They must destroy stocks of printed matter; and they must invest
heavily in new printing type and new supplies.
The alternative to compliance would risk serious criminal and
civil penalties for the unlawful distribution of "misbranded"
Reversed and remanded