American Home Products Corporation

Text (OCR of the scan at left; may contain errors)

IN THE MATTER OF AMERICAN HOME PRODUCTS CORPORATION MODIFYING ORDER IN REGARD TO ALLEGED VIOLATION OF THE FEDERAL TRADE COMMISSION ACT Docket 8641. Order, June 1970-Modifying Order, May, 1986 The Federal Trade Commission has modified a 1970 order with American Home Products Corp. (77 F. C. 726) by removing some restrictions on the company advertising for Preparation H. The modified order allows respondent to use in its advertising any claims that the Food and Drug Administration has tentatively approved.

ORDER REOPENING THE PROCEEDING AND MODIFYING CEASE AND DESIST ORDER On January 21 1986, American Home Products Corporation (Petitioner) fied a petition pursuant to Rule 2.51 of the Commission , and Paragraph In of the order inRules of Practice, 16 C. R. 2. question to reopen the proceeding and modify the final cease and desist order entered against it by the Commission on June 9, 1970, in Docket No. 8641 (77 F. C. 726).

The final order in this matter was the product of extended litigation concerning therapeutic advertising claims for Preparation H Ointment or Suppositories. The order effectively proscribes all therapeutic advertising claims for Preparation H Ointment or Suppositories, or any other non-prescription drug product for the treatment or relief of hemorrhoids or any of its symptoms, except for three specifically enumerated claims. The three claims permitted under the order are (1) that the use of the product wil help reduce swellng of hem or rho idal tissue caused by edema, infection, or inflammation; (2) that the use of the product wil help reduce swelling of hemorrhoidal tissue by lubricating the affected area; and (3) that use of the product wil afford temporary relief of pain and itching of hemorrhoidal tissue in many cases. The order concludes with a proviso (Part II) that if the Food and Drug Administration (FDA) should approve for such products any other claims as permissible in labeling, respondent may petition for a modification of the order on that ground. Subsequently, the Food and Drug Administration (FDA) undertook a comprehensive review of the safety and effectiveness of over-thecounter (OTC) drug products under the "Drug Amendments of 1962" to the "Federal Food, Drug and Cosmetic Act." As part of this review the FDA appointed panels of independent experts in medicine and Modifying Order 107 F. pharmacology to review the available literature and data and evaluate the safety and effectiveness of ingredients used in OTC products. After completing their evaluations the panels reported their findings and conclusions concerning the classes ofOTC products evaluated and recommended appropriate labeling claims for each of the classes of OTC products reviewed. The labeling recommendations are incorporated into proposed monographs which, after a three step procedure designed to determine appropriate revisions, if any, will be promulgated as final monographs or rules which wil govern the labeling claims of OTC products. One such panel reviewed and evaluated OTC hemorrhoidal (anorectal) drug ingredients. Its findings and conclusions and recommendations and a proposed monograph for OTC anorectal drugs were published in the Federal Register on May , 1980. (45 FR 35575.

It is this proposed monograph that forms the basis for Petitioner requested modification. Under this proposed monograph OTC anorectal drug ingredients are classified into several groups on the basis of their pharmacologic action, such as local anesthetics, vasoconstrictors, protectants, and counterirritants. An OTC anorectal drug can be classified as a protectant if, for example, it contains cocoa butter 50 percent or greater per dosage unit or it contains white petrolatum USP 50 percent or greater per dosage unit. An OTC anorectal drug meeting these percentage requirements would be entitled under the proposed monograph to be labeled with certain specific protectant claims.

Petitioner claims that Preparation H Ointment contains 72.8% petrolatum and that Preparation H Suppositories contains 79. cocoa butter thereby qualifying those products as protectants under the proposed monograph. As a consequence, Petitioner argues that it should be entitled to make as labeling claims those claims permitted by the FDA under the proposed monograph. However, the Commission s final order prohibits the use of a number of these claims and Petitioner asserts this prohibition places it at a competitive disadvantage with OTC anorectal protectant drug products marketed by others. As a consequence, Petitioner has requested that the final order be modified to allow it to make all advertising claims it is allowed by the proposed monograph to use in its labeling for Preparation H Ointment or Suppositories.

We agree. In prior decisions, we have held that proposed FDA monographs may be relied on as a reasonable basis for performance claims. ARC Pharmacal, Inc. 101 F. C. 40, 43 (1983); Thompson Medical Co. Inc. 104 F. C. 648, 826 (1984); Chesebrough-Pond's Inc. Docket No. C-602 (November 25 1985) (106 F. C. 567) Such relief is particularly appropriate where, as here, the advertising claims would 427 Modifying Order be dependent on their acceptability as labeling claims. Based on the foregoing, we conclude that Petitioner has made the requisite showing for a reopening of the proceeding and a modification of the order under Rule 2.51 and Paragraph III ofthe final order. Respondent has asked that Part III ofthe final order. Respondent has asked that Part III ofthe order be modified to make clear that it may make claims in advertising that the FDA has allowed in labeling. It is therefore ordered, That the proceeding is hereby reopened and that Paragraph II of the final order issued June 9, 1970, in Docket No. 8641 be, and it hereby is modified to read as follows: III. This order is not intended to nor does it prohibit respondent from making any representations for non-prescription drug preparations for the treatment or reliefofhem rrhoids or any of their symptoms which the Food and Drug Administration has determined, in the course of its over-the-counter drug review, relate to conditions for which the drug preparation is generally recognized as safe and effective and not misbranded. In the event that respondent at any time in the future markets any non-prescription drug preparation for the treatment or relief of hemorrhoids or any of its symptoms for which it desires to make any of the representations now prohibited under Paragraph I ofthe order, it may petition the Commission for a modification of the order. Such petition shall be accompanied by a showing that the representation is not false or misleading within the meaning of the Federal Trade Commission Act.

Commissioners Oliver and Strenio did not participate. Complaint 107 F.