published study on the effects of the drug in a closely controlled situation.
The claimant offers the testimony of two physicians as to their professional experience with PPA and as to the tests conducted by them, one on dogs and the other on office patients. The latter test was designed, according to its creator, solely to determine the safety of a timed release capsule containing PPA. The claimant also offered the 1942 Kalb study on 1880 obese patients and numerous citations from drug encyclopedias to the effect that PPA has an appetite depressant quality.
The dog study of Doctor Bohensky, although it may be persuasive as to the anorexigenic potency of PPA upon dogs, would seem to be only of preliminary value where humans are concerned. Claimant introduced no convincing evidence that the physiological reactions of dogs and humans who had ingested PPA would be the same. Libelant's witnesses strongly contested such a conclusion and their contention seems most probable. The chemical study of Doctor Feinblatt cannot be considered to be a scientific study of the weight-reducing effect of PPA upon human beings, for its author stated that it was designed solely as a test of the safety of the drug and that therefore certain elements necessary for a valid test of its anorexigenic action were omitted from the design.
The study made in 1942 by Doctor Kalb does not provide us with a scientific basis for evaluating it or for comparing its results and method with those of the Fazekas study and the court regrets that Doctor Kalb, who apparently practices medicine here in Newark, N.J., was not called by either side as a witness in order to explain, more fully than they are set forth in the published report, the procedures that the followed and the results that he obtained.
The various pamphlets and articles submitted by the claimant were considered, but their inferences and opinions must yield to the persuasive force of the evidence brought out at the trial.
Claimant contends that the Food and Drug Administration has changed its position as to the appetite depressant effect of PPA and that originally it approved the marketing of the drug as an effective anorexiant. Assuming that this be true, it is also true that the Administration has a duty to change its position with reference to the efficacy of a drug if subsequently it learns that its original position was in error.
An examination of all the evidence presented compels the conclusion that a daily dosage level of 78 mg. PPA has no significant pharmacological value as a weight-reducing agent and that therefore any representation to the effect that PPA in that dosage is an adequate and effective appetite depressant or that it is adequate and effective in the management or control of obesity, would be a misbranding within the meaning of Title 21 U.S.C. § 352(a). The court finds that the labeling of claimant's product Unitrol represents that its sole active ingredient PPA is adequate and effective for the above purposes and consequently that this product is to be condemned according to the provisions of Title 21 U.S.C. § 334(d).
Since the court has considered the biological and physiological effects of PPA, and the general character of the labeling which represents that PPA depresses the appetite with a consequent significant loss of weight, not confining its opinion to the greater claims made by the labeling in the instant case such as a loss of fourteen pounds in fourteen days, it feels that its conclusions are dispositive of all of the cases involving this product which are presently before the court.
This opinion shall serve as findings of fact and conclusions of law.
Let an order be submitted in conformity herewith.
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