might still attempt to salvage Mykocert by using the other
avenue available — that absence of recognition for Mykocert as
such is irrelevant given the fact that its component parts are
generally recognized. Claimant does in fact place great faith
in this contention by directing a vast amount of literature to
the effectiveness and recognition of tampons and aminoacridines
generally for use on infections. In order for this argument to
succeed Mykocert in its present state must be similar enough in
form, dosage, purpose, and application to the general usage of
aminoacridines so as to be within the genre "aminoacridine" and
the general recognition attributed to that genre. If Mykocert
deviates in any substantial degree from previous forms of
aminoacridine usage then it cannot rely on the general
recognition of its component parts. The regulations in fact
indicate that combinations of "old" drugs may be a "new" drug
as is stated in 21 C.F.R. § 130.1(h)(1) through (5). See supra,
pages 6 and 7.
Simply stated under the drug laws the whole of a drug may be
greater or "newer" than all of its parts.
How critical this factor becomes to our case is evidenced in
the fact that the vast majority of claimants' affidavits and
documents are directed at the recognition of the component
parts of Mykocert rather than to the exact form and dosage of
Mykocert. There is a vast amount of literature on
aminoacridines, affidavits on the efficacy of and recognition
of aminoacridines and literature on tampon usage and claimant
adds up the general recognition of tampon usage and
9-aminoacridine usage and comes up with a total of
non-newness. Thus if we determine that Mykocert is more than
just the component parts of tampons and aminoacridines,
claimant is practically foreclosed from succeeding based on
its almost total reliance on affidavits directed at the
component parts rather than the whole.
In adding up the tampon and aminoacridine usage we do not
come up with a total of Mykocert. In view of the fact that the
14 mgs. dosage of Mykocert is a much larger dosage than used
in other aminoacridine medications for vaginal infections;
given the tampon form of application which is unlike gell
tablet and cream form of application of vaginal infection
medication; that the element of polyvinylpyrrolidone is added
as a chemical binder, we hold that Mykocert is a new drug as
defined in 21 C.F.R. § 130.1(h)(5) i. e. "The newness of a dosage
or method or duration of administration or application
[constitutes newness] . . . even though when used in other
dosage, or method of duration or administration on
application . . . is not a new drug."
We believe that the new dosage and form of application
creates greater risks and questions of safety and
effectiveness than previously recognized forms of medication
for vaginal infections and given the delicate area of its
application — warrants a finding of "newness."
We are supported by two recent cases in our district in
regard to combinations. Both United States v. . . .
Aspersleep, 71 C 235 and United States v. . . . Xerac, 70 C
106 dealt with component parts that might have been generally
recognized yet found that there was no general recognition for
the new drug formed by the combination.
The fact that Mykocert is sufficiently newer than its
component parts renders the greater amount of claimant's
substantiating evidence irrelevant since it applies only to
the parts rather than the whole.
To summarize, then, we are satisfied that based on all the
documents and evidence submitted there is no general
recognition among qualified experts that Mykocert as such is
safe and effective and that claimant cannot rely on the
recognition of its component parts since the combination is a
new drug within the meaning of the regulations. Mykocert is
therefore a new drug and not exempt from the statutes under
which forfeiture by the Government was accomplished.
Judgment will be entered for the United States.
© 1992-2003 VersusLaw Inc.