The opinion of the court was delivered by: Marovitz, District Judge.
On January 29, 1971, subsequent to the filing of a Complaint
For Forfeiture, the Plaintiff seized a quantity of the
prescription drug, Mykocert medicated vaginal tampons pursuant
to the provisions of 21 U.S.C. § 301 et seq. and now seeks a
decree of condemnation in regard to the drug seized.
The Complaint alleges that the seized article of drug was
misbranded while held for sale after shipment in interstate
commerce within the meaning of the Act, 21 U.S.C. as follows:
§ 352(a) in that its labeling, namely, the box label,
contains statements which represent and suggest that the
article is adequate and effective as a treatment of most
vaginal infections caused by Gram-positive and Gram-negative
organisms, which statements are false and misleading, since the
article is not adequate and effective for such conditions; and
352(f)(1) in that it is a drug and its labeling fails to
bear adequate directions for use and it is not exempt from
such requirement, under the regulations, 21 C.F.R. § 1.106(g),
since the article is a new drug subject to the provisions of
21 U.S.C. § 355, and no approval of an application filed
pursuant to 21 U.S.C. § 355(b) is effective with respect to
such drug, and no notice of claimed investigational exemption
under 21 U.S.C. § 355 (i) and regulations 21 C.F.R. § 130.3 is on
file for such drug.
Beutlich, Inc., the pharmaceutical company which
manufactures Mykocert, filed a claim for the seized articles
and interrogatories were subsequently served and answered by
both sides. Plaintiff has filed a motion for summary judgment
and claimant has filed a cross-motion for summary judgment,
both motions appended by a voluminous amount of affidavits,
expert's opinions and substantiating material. Both Plaintiff
and claimant were granted leave for oral argument on their
respective motions and all parties entered into the very
important stipulation that should the Court decide that it
cannot or does not wish to dispose of the case within the
limitations of the summary judgment rule that it may proceed
to decide on the merits taking into consideration the
affidavits, depositions, interrogatories and other information
now on file as refined and distilled by oral argument. We are
now prepared to render that decision.
There are five conceivable defenses that claimant could have
raised to the Government's § 352(f)(1) grounds for forfeiture.
It could have claimed that Mykocert indeed bore adequate
instructions for lay use as required by § 352(f)(1) and
21 C.F.R. § 1.106(a) but was foreclosed from doing so since Mykocert is a
prescription drug and by its very nature cannot bear such
instructions. It could have claimed exemption from the adequate
directions requirement as provided by 21 C.F.R. § 1.106(g) for new
drugs but no approval of an application pursuant to 21 U.S.C. § 355(b)
was effective for Mykocert and no notice of claimed
investigational exemption under 21 U.S.C. § 355(i) and
21 C.F.R. § 130.3 has been filed with the United States Food and Drug
Administration which would have allowed for such an exemption.
Mykocert could have qualified for the prescription drug
exemption provided for by 21 C.F.R. § 1.106(b) by bearing labeling
authorized by an approved new drug application but claimant has
not filed a new drug application. The fifth and final avenue
and the one chosen by claimant is that Mykocert is not a "new"
drug as defined in 21 U.S.C. § 321 and 21 C.F.R. § 130.1 and that
even though § 352(f)(1) is inapplicable because of the drug's
prescriptive nature the non-newness of the drug exempts it from
any of the requirements of the previously mentioned
alternatives such as application or filing with the Federal
Drug Administration. Thus the entire crux of the case is
dependent on the one critical decisive issue as whether
Mykocert is or is not a new drug.
The criteria for determining whether or not a drug is "new"
appears in various statutes and regulations and is further
delineated by numerous cases.
The essential starting point in a definitional survey of a
"new drug" is 21 U.S.C. § 321 which states:
(p) The term "new drug" means —
(1) Any drug . . . the composition of which is
such that such drug is not generally recognized,
among experts qualified by scientific training
and experience to evaluate the safety and
effectiveness of drugs, as safe and effective for
use under the conditions prescribed, recommended,
or suggested in the labeling thereof. . . .
The regulations in 21 C.F.R. § 130.1(h) further indicate the
various conceivable ...