American Home Products Corporation

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IN THE MATTER OF AMERICAN HOME PRODUCTS CORPORATION MODIFYING ORDER IN REGARD TO ALLEGED VIOLATION OF SEC. 5 OF THE FEDERAL TRADE COMMISSION ACT Docket 918. Final Order, September 1981-Modifying Order June, 1984 This order reopens the proceeding and modifies the Commission s order issued on September 9 1981, (98 F. 136), modified April 8, 1983 (101 F. C. 698), modified further Feb. 1984 003 F. G 57) so that its basic provisions are in parity with the Commission order in Bristol-Myers Company, (102 C. 21 (1983)) and Sterling Drug, Inc. (102 F. C. 395 (1983)). Under the modified order, the company must have a reasonable basis consisting of reliable scientific evidence for all therapeutic performance or safety claims. The previous order covered such claims only if they compared one product to another.

ORDER REOPENING THE PROCEEDING AND MODIFYING CEASE AND DESIST ORDER Respondent American Home Products Corporation in a !!renewed request" fied on January 27, 1984, petitioned to reopen these proceedings and modify the Order. This request was placed on the public record for comment, with no comments fied.

On April 5, 1984, pursuant to discussion with Commission staff respondent fied a proposed Order which was agreed to by staff. This proposed Order suggests changes in the Modified Order to Cease and Desist of April 8, 1983, as modified by Order of February 7 1984. The proposed Order adds a new paragraph l(A)(4) and substitutes new language for paragraphs l(B), III, and IV. With these modifications the basic provisions of this Order wil be in general parity with the Commission s Orders in Bristol-Myers Company, Docket No. 8917 (102 C. 21 (1983)) and Sterling Drug, Inc. Docket No. 8919. (102 F. 395 (1983)) The Commission being of the opinion that the public interest would be served by such reopening of the proceedings; . Now, therefore, it is ordered, That the proceedings in Docket No. 8918 be, and they hereby are, reopened; and It is further ordered That the Order in Docket No. 8918 be substituted as to respondent American Home Products Corporation by a modified Order as follows:

AMERICAN HOME PRODUCTS CORP. 52f 528 Modifying Order ORDER It is ordered That respondent American Home Products Corporation, its successors and assigns and respondent' s offcers, agents, representatives and employees; directly or through any corporation subsidiary, division or other device, in connection with the advertising, offering for sale, sale or distribution of "Anacin Arthritis Pain Formula " or any other non-prescription internal analgesic product in or affecting commerce, as commerce is defined in the Federal Trade Commission Act, do forthwith cease and desist from: A. Making any representation, directly or by implication, that a claim concerning the superior effectiveness or superior freedom from side effects of such product has been established or proven unless such representation has been established by two or more adequate and well-controlled clinical investigations, conducted by independent experts qualified by training and experience to evaluate the comparative effectiveness or comparative freedom from side effects of the drugs involved, on the basis of which it could fairly and responsibly be concluded by such experts (1) that the drug will have the comparative effectiveness or freedom from side effects that it is represented to have, and (2) that such comparative effectiveness or freedom from side effects is demonstrated by methods of statistical analysis, and with levels of confidence, that are generally recognized by such experts. The investigations shall be conducted in accordance with the procedures set forth below:

At least one of the adequate and well-controlled clinical investigations to evaluate the comparative effectiveness of the drug shall be conducted on any disease or condition referred to, directly or by implication; or, ifno specific disease or condition is referred to, then the adequate and well-controlled clinical investigations shall be conducted on at least two conditions or diseases for which the drug is effective. The clinical investigation shall be conducted as follows: 1. The subjects must be selected by a method that: a. Provides adequate assurance that they are suitable for the purposes of'he investigation, and diagnostic criteria of the condition to be treated (if any);

b. Assigns the subjects to the test groups in such a way as to minimize bias; and c. Assures comparability in test and control groups of pertinent FEDERAL TRADE COMMI::NV" uO Modifying Order 103 F.

,riables, such as age, sex, severity or duration of disease or condition f any), and use of drugs other than the test drugs. 2. The investigations must be conducted double-blind, and methods f double-blinding must be documented. In addition, the investiga- Ions shall contain a placebo control to permit comparison of the esults of use of'he test drugs with an inactive preparation designed o resemble the test drugs as far as possible. 3. The plan or protocol for the investigations and the report of the esults include the following:

a. A clear statement of the objective of the investigation; b. An explanation of the methods of observation and recording of results, including the variables measured, quantitation, assessment of any subject's response and steps taken to minimize bias on the part of subject and observer;

c. A comparison of the results of treatments or diagnosis with a control in such a fashion as to permit quantitative evaluation. The precise nature of the control must be stated and an explanation given of'he methods used to minimize bias on the part of'he observers and the analysts of the data.

d. A summary of the methods of analysis and an evaluation of data derived from the study, including any appropriate statistical methods.

4. A test or investigation which is not conducted in accordance with these procedures may be used to establish a claim only if respondent can show that, notwithstanding the failure to satisfy these procedures, the test or investigation would stil be generally accepted the relevant scientific community as suffcient to establish the truth of the claim.

B. Making any therapeutic performance or freedom from side effects claim for such product unless respondent possesses a reasonable basis for making that 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 IA shall be deemed to constitute a reasonable basis for a claim.

It is further ordered That respondent American Home Products Corporation, its successors and assigns and respondent's offcers agents, representatives and employees, directly or through any corporation, subsidiary, division or other device, in connection with the advertising, offering for sale, sale or distribution of " Anacin Arw 528 Modifying Order thritis Pain Formula " or any other non-prescription drug product, in or affecting commerce, as Hcommerce" and Hdrug" are defined in the Federal Trade Commission Act, do forthwith cease and desist from: A. Making any representation, directly or by implication, that such product contains any unusual or special ingredient when such ingredient is commonly used in other non-prescription drug products intended for the same use or uses as the product advertised by respondent.

B. Making any false representation that such product has more of an active ingredient than any class of competing products. C. Misrepresenting in any manner any test, study or surveyor any of the results thereof, concerning the comparative effectiveness or freedom from side effects of such product.

It is further ordered, That respondent American Home Products Corporation, its successors and assigns, and its offcers, agents, representatives and employees, directly or through any corporation, subsidiary, division or other device in connection with the advertising, offering for sale, sale or distribution of !'Anacin " or HArthritis Pain Formula," or any other nonprescription internal analgesic in or affecting commerce, as "commerce" is defined in the Federal Trade Commission Act, do forthwith cease and desist from falsely representing that the analgesic ingredient in an aspirin-containing product is different from aspirin or otherwise misrepresenting the identity of any analgesic ingredient. It shall be a violation of this paragraph to contrast the analgesic ingredient of a product which contains aspirin with the analgesic ingredient of another product if that product also contains aspirin, unless respondent discloses clearly and conspicuously that the analgesic ingredient in its product is aspirin. This provision shall not become effective until Orders in Dockets 8917 and 8919 have become final. (102 F. C. 21 , 395 (1983)) If the Commission makes any changes in the Orders entered Dockets 8917 and 8919, respondent American Home Products Corporation may petition the Commission to make similar changes in the corresponding provisions, if any, of this Order. This paragraph shall not be deemed to limit respondent' s right to petition for modification pursuant to any applicable statute or regulation. Modifying Order 103 F.

It is further ordered That respondent American Home Products Corporation, shall notify the Commission at least thirty (30) days prior to any proposed change in the respondent such as dissolution assignment or sale resulting in the emergency of a successor corporation, the creation or dissolution of subsidiaries or any other change in the corporation which may affect compliance obligations under this Order.

It is further ordered That the respondent herein shall within sixty (60) days after service of this Order, and at such other times as the Commission may require, fie with the Commission a written report setting forth in detail the manner and form in which it has complied or intends to comply with this Order.

533 Interlocutory Order