Bristol-Myers Company

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IN THE MATTER OF BRISTOL-MEYERS COMPANY, ET AL.

Docket 8917. Interlocutory Order, Opinion, Oct. , 1983 OPINION OF THE COMMISSION By CLANTON Commissioner:

Respondent, Bristol-Myers Company ("Bristol") has fied a petition for reconsideration asking that the Commission delete two paragraphs of the order entered against it on July 5, 1983 (102 F. C. 21) Bristol asserts that Paragraph II of the order places the company at a competitive disadvantage and is excessively vague and not reasonably related to the violations giving rise to it. Bristol contends Paragraph III-A should be deleted because our order dismissed all the claims on which it was premised. In addition, Bristol asserts that marketplace changes have eliminated entirely the need for the kind of relief ordered in the two provisions. For the reasons stated below the petition is denied in its entirety.

Paragraph II Paragraph II of our order reads in pertinent part: It ordered That respondent Bristol-Myers do forthwith cease and desist from making any therapeutic performance or freedom from side effects claim for Bufferin Excedrin, or any other nonprescription internal analgesics unless respondent possesses a reasonable basis for making that (2) claim. A reasonable basis for such a claim shall consist of competent and reliable scientific evidence supporting that claim. Well-controlled clinical tests conducted in accordance with the criteria set forth in Order Paragraph I shall be deemed to constitute a reasonable basis for a claim. Bristol contends that Paragraph II places it at an unwarranted competitive disadvantage vis-a-vis its competitor, American Home Products Corporation ("AHP"), because a "virtually identical" provision in the order we entered against AHP (Paragraph II(D)) was deleted by the Third Circuit on AHP' s petition for review. See American Home Products Corp. v. FTC (AHPJ, 695 F.2d 681, 710-711 (3d Cir. 1982).

Preliminarily, we disagree that the two provisions are "virtually identical". The provision deleted on AHP's petition for review was directed to noncomparative representations of effectiveness or freedom from side effects of all over-the-counter drugs. By contrast, Paragraph II ofthe order in this case applies only to claims concerning the company s internal analgesics. It was this greater breadth of the AHP order that constituted one of the Third Circuit's objections to it. 1326 FEDRRAL TRADE COMMISSION DECISIONS Opinion 102 F.

Even more important is the fact that the only violation of the sort prohibited by Paragraph IID) that AHP actually committed was covered by another provision in its order. Moreover, the AHP order contains provisions not found in the Bristol order, and taken as a whole, provides protection against deceptive advertising at least as great. To delete the corresponding provision in this case would mean that the numerous nonestablishment performance and freedom from side effects claims made by Bristol (see slip op. at 7-17) (102 F. C. at 321-330) would not be covered by any other provision in our order and Bristol would be free to engage in deceptive advertising now foreclosed by order to its competitors.

Bristol next argues that Paragraph II is impermissibly vague because it does not specify the amount and kinds of evidence that are necessary to constitute a reasonable basis for future claims. We believe that Bristol will have no diffculty in applying the requirements of Paragraph II to its contemplated future advertising. In its opinion the Commission construed the \Ireasonable basis" requirement of Paragraph II to mean "competent and reliable scientific evidence." We also specified a type of scientific evidence that wil always satisfy that standard- , two well-controlled clinical trials' (Slip op. at 71). (102 F. C. at 375) (3) However, because we were unable to determine on the basis of the record whether some lesser standard might ever constitute a reasonable basis, we fashioned an order that allows Bristol to show in a given case that a lesser amount of support is adequate. Indeed, it is the advertiser who best knows the product and is best situated to verify the accuracy of claims made for it Sears Roebuck Co. v. FTC, 676 F.2d 385, 400 (1982). Should a situation arise in which Bristol is genuinely unable to determine whether two well-controlled clinical trials are required, it can, by complying with Rule 2.4l(d) of the Commission s Rules of Practice and Procedure obtain definitive advice as to whether its profferred substantiation would satisfy the order. See, e. , FTC v. Colgate-Palmolive Co., 380 S. 374 , 392 (1965); Jay Norris, Inc. v. FTC 598 F.2d 1244, 1251 (2d Cir. 1979).

Bristol' s final objection to Paragraph II is that it is premised on too slender a basis- , the tension relief claims for Bufferin and Excedrin. In support ofthis argument it relies on the portions of the Third Circuit' s opinion in AHP that explain why the one noncomparative tension-relief claim for Anacin did not justify imposing a reasonable basis requirement on all effcacy and freedom-from-side effects claims for all over-the-counter drugs.

L Thus this case ditlen; fromSt, ndflnl OilCo. v. FT, 577 F.2d 653 (9th Cir- 1978). There, the courtofappearn rejected the Commission s suggestion that any vagueness could be cured by an advisory opinion because various paragraphs of the Commi.'sion g order simply restated general principles of fair advertising. 577 F.2d at 661. 1325 Opinion Paragraph II, however, is more solidly based and more narrowly drawn. The only advertising claim made by AHP in the category proscribed by Paragraph II(D) of our order was the one noncomparative tension-relief claim for Anacin. Bristol, on the other hand, disseminated at least 20 inadequately substantiated tension-relief claims for Bufferin and Excedrin (slip op. at 44-48) (102 F. C. at 353-356) and also claimed without a reasonable basis that Bufferin would cause no stomach upset (slip op. at 30-31) (102 F. C. at 341- 342). Finally, in contrast to the provision that we entered against AHP, Paragraph II is narrowly limited to internal analgesics-the specific product category for which the offending claims were made. Thus, there is no conflict with the Third Circuit's decision in AHP, which, as noted before, sustained a Commission order that taken as a whole was at least as extensive as that here. Paragraph Ili- Paragraph III-A of our order prohibits Bristol from representing that any nonprescription drug product contains an unusual" or special" ingredient when in fact the ingredient is commonly used in other nonprescription drug products that are intended for the same use. Bristol objects that the provision is inappropriate in view of our decision to dismiss the allegations of the complaint that charged the company with falsely (4) representing the uniqueness of the ingredients in Excedrin P. M. See slip op. at 56-57. (102 F. C. at 362-363) Paragraph III-A is not, however, premised on the advertisements for Excedrin P. M. See slip op. at 73. (102 F. C. at 377) Rather, it was based on the advertisements for Bufferin and Excedrin that falsely claimed that the analgesic ingredient was something other than aspirin (the violation specifically prohibited by Paragraph IV) and that also implied that those ingredients were special and unusual. Seeslip op. at 50-52. (102 F. C. at 358-359) Marketplace Changes Finally, Bristol contends that Paragraphs II and III-A should be deleted because it faces the growing market dominance ofMcNeilab' Tylenol and a significant increase in private enforcement under the Lanham Act, similar state statutes, and through the advertising industry s self-regulatory mechanism.

Under Section 3.55 of the Commission s Rules of Practice the scope of petitions for reconsideration is limited to "new questions raised by the decision or final order upon which the petitioner had no opportunity to argue before the Commission. Bristol, having had adequate opportunity to raise these contentions before the administrative law judge and again on its appeal from the law judge s decision, cannot Interlocutory Order 102 F. now assert them for the first time in a petition for reconsideration of our final order.

CONCLUSION For all the foregoing reasons the petition for reconsideration is denied in its entirety.

ORDER DENYING RESPONDENT BRISTOL-MYERS PETITION FOR RECONSIDERATION An opinion and final order in this matter were issued on July 5 1983. (102 F. C. 21) Respondent Bristol-Myers was served with the opinion and order and petitioned for reconsideration thereof on August 8, 1983. The Commission, for reasons stated in the accompanying opinion, has determined to deny Bristol-Myers' Petition for Reconsideration. Therefore It is ordered That Respondent Bristol-Myers' Petition for Reconsideration be, and hereby is, dismissed.

STERLING DRUG, INC.. ET AL. l:J:ltt 1329 Opinion