sodium mfp has a desensitizing effect, and therefore that
Silverman's failure to test Promise against a fluoride toothpaste
does not invalidate the research results, particularly since 80%
of the test participants had used fluoride toothpaste before
entering the study. Id. These experts further note that the
duration of the experiment — 12 weeks — is in excess of the
8-week period recommended by the FDA expert advisory panel and
considered adequate by the ADA in testing for the safety and
effectiveness of potassium nitrate alone. Id. For purposes of the
present motion, the court has assumed that the opinions expressed
by defendants' declarants represent those of the majority of
qualified experts. The court will assess whether relevant
statutory standards nonetheless compel a conclusion that Promise
with Fluoride and Sensodyne-F are "new drugs."
A. General Recognition in Fact
In its memoranda for summary judgment, the FDA argues, as it
apparently has in other cases, see, 5,906 Boxes, 745 F.2d at 119
n. 22, that any "conflict" of opinion among medical experts is
sufficient to mandate a legal conclusion that general recognition
of Promise's effectiveness does not exist. Many cases contain a
statement to this effect. See, e.g., Premo Pharmaceutical
Laboratories, 629 F.2d at 803 ("either the unawareness of the
drug product by experts generally or a genuine dispute among
qualified experts regarding a drug product's safety and
effectiveness preclude its qualifying for exclusion as `generally
recognized.'"). Accord, Equidantin, 675 F.2d at 1000; Western
Serum Co., 666 F.2d at 338; United States v. An Article of
Drug . . . "Bentex Ulcerine," 469 F.2d 875, 880 (5th Cir. 1972),
cert. denied, 412 U.S. 938, 93 S.Ct. 2772, 37 L.Ed.2d 397 (1973);
United States v. Articles of Drug . . . Hormonin, 498 F. Supp. 424,
431 (D.N.J. 1980), aff'd, 672 F.2d 904 (3d Cir. 1981).
Despite this impressive array of authority, the court must
disagree. The above line of cases can be traced back to dicta in
United States v. 354 Bulk Cartons . . . Trim Reducing-Aid
Cigarettes, 178 F. Supp. 847 (D.N.J. 1959) and Merritt Corp. v.
Folsom, 165 F. Supp. 418 (D.D.C. 1958), in which it was stated
that a mere conflict between qualified experts establishes a lack
of general recognition as a matter of law. In United States v. 7
Cartons . . . Ferro-Lac, 293 F. Supp. 660 (S.D.Ill. 1968), aff'd
in part, vacated in part, 424 F.2d 1364 (7th Cir. 1970), the
district court thoughtfully pointed out the inadequacies of this
statement as a rule for general application:
[T]he government's contention cannot be accepted as a
sound principle of procedural law for application to
this statute. The statute provides a test of general
recognition. The rule stated in Merritt and
subsequent cases would equate the statutory language,
"generally recognized" to "unanimously recognized."
There is no justification for such equation. There is
nothing in the statute to indicate that Congress
intended "generally recognized" in other than its
commonly understood meaning. The adverb, "generally,"
is defined, inter alia, to mean ". . . extensively,
though not universally" . . . .
Where, as here, each party has submitted affidavits
in support of its position, the court must examine
those affidavits to determine whether a genuine
difference of expert opinion is presented. If such
difference of opinion appears, decision must abide
the results of a trial of the issues.
293 F. Supp. at 662-63 (citations omitted). See also 5,906 Boxes,
745 F.2d at 119 n. 22. ("[U]nanimity among experts is not
required to demonstrate `general' recognition.") United States v.
Articles of Food and Drug (Coli-Trol 80),