Walgreen Co

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

IN THE MATTER OF WALGREEN CO.

CONSENT ORDER, ETC., IN REGARD TO ALLGED VIOLATION OF SECS. 5 AND 12 OF THE FEDERAL TRADE COMMISSION ACT Doket C-3214. Complaint, June 10, 1987-Decision, June 10, 1987 This consent order prohibits, among other things, a Deerfield, Ill.-based retail drugstore chain from making unsubstantiated advertising claims for "Advil" pain reliever or any other over-the-counter analgesic drug product. Appearances For the Commission: Donna S. Moffa. For the respondents: Robert L. Ward and Robert A. SkitoZ Ward Harkrader Ross, Washington, D.C.

COMPLAINT The Federal Trade Commission, having reason to believe that Walgreen Co., a corporation, has violated the provisions of the Federal Trade Commission Act, and it appearing to the Commission that a proceeding by it in respect thereof would be in the public interest alleges:

PARAGRAPH 1. Walgreen is an Ilinois corporation with its principal offce or place of business located at 200 Wilmot Road, Deerfield Ilinois.

PAR. 2. Walgreen offers for sale and sells over-the-counter drug products.

PAR. 3. Walgreen has disseminated or caused to be disseminated advertisements for over-the-counter drug products, which products are "drugs" within the meaning of that term in Section 12 of the Federal Trade Commission Act. These advertisements have been disseminated by various means in or affecting commerce, including newspapers distributed across state lines and radio broadcasts transmitted across state lines, for the purpose of inducing and which were likely to induce, directly or indirectly, the purchase in or having an effect upon commerce of drugs.

PAR. 4. The acts and practices of Walgreen alleged in this complaint have been in or affecting commerce.

PAR. 5. Typical of Walgreen s advertisements, but not necessarily inclusive thereof, are the Walgreen advertisements attached hereto . . ._ , . . . .. .. . . 156 Complaint as Exhibits A through E. Specifically, the aforesaid Walgreen advertisements contain the following statements: a. "Prescription Pain Reliever. without a prescription! ADVIL is 200 mg. Ibuprofen for pain. One of the most prescribed pain relievers. Anti-inflammatory and analgesic comfort for people with arthritis. " (Exhibit A) b. "Now available without prescription. Advanced ' ADVIL' Non-narcotic antiinflammation Ibuprofen 200 mg. for pain relief." (Exhibit B) c. "ADVIL. Generic equivalent of Motrin, No prescription necessary. " (Exhibit C) d. "An anti-inflammatory and an analgesic, ADVIL is a source of comfort for people who experience arthritis pain. " (Exhibit D) e. "One ofthe world' most-prescribed pain relievcrs-known to milions as Ibuprofen is now available without a prescription, at Walgreens! ADVIL . . . a highly effective, non-narcotic, anti-inflammatory pain reliever. " (Exhibit E) PAR. 6. Through the use of the statements referred to in Paragraph Five (a) through (e), and other statements in advertisements not specifically set forth herein, Walgreen has made the following material representations, directly or by implication: a. Consumers can substitute "Advil " in over-the-counter dose levels, for prescription ibuprofen, because when so substituted Advil" provides all of the same therapeutic benefits to consumers as prescription ibuprofen. b. "Advil " in over-the-counter dose levels, provides an anti-inflammatory benefit to consumers.

PAR. 7. Through the use of the statements set forth in Paragraph Five, and others not specifically set forth herein, Walgreen has represented, directly or by implication, that at the time of making the representations set forth in Paragraph Six it possessed and relied upon a reasonable basis for those representations. PAR. 8. In truth and in fact, at the time ofthe initial dissemination ofthe representations set forth in Paragraph Six and each subsequent dissemination, Walgreen did not possess and rely upon a reasonable basis for making such representations. Therefore, Walgreen s representation set forth in Paragraph Seven was and is false and misleading.

PAR. 9. The acts or practices of Walgreen, as alleged in this complaint, constitute unfair or deceptive acts or practices in or affecting commerce and false advertisements in violation of Sections 5 and 12 of the Federal Trade Commission Act.

Chairman Oliver was recorded as voting in the negative. ,, , ;. .. . . .. , .. .. . ..... .. . .. , , ...... ... Complaint 109 F. T. EXHIBIT A r),(l ro., Ptoipti without a ",rjp ADVIL II 200 mg.

Ibuprofen for-0.01.......Pain pt81r,be PO'"

. Anfj.,nfl""mC'OI) b-an /wonlqocpe,.Con- "';"'an,iO "'.-1i j(OI Gw II ,.

"1' 2I... 19t;)" N Lo 250' S_t'01 .-1q .. Po "":dmum99- Seno!\ Sup Oclne. O'ef pion ""LIlY'S Senokot COfiST..,..non laxative 1I''',UII',a, Tabs 100' '''''..0:-. SI.Fas fola If .. 1-- CDpc. 99"" SI/..- D OottICI- . I . t!B,'"

, . ./ , $ ..: .lf1l Ifl(ltJ''J"r "

li!.IJJ !f 1 II /11 $ ,,. .. Complaint 109 F.

EXHIBIT C LOREAL NAIL POLISH Walgreen' Choice 01 DIAPERS bnuUIu oh- 38_or 81 24 f: '-d SEA BREEZE ANTISEPTIC ADYIL 100L boll lor 8k care ai_No l1ltp _al"r'. FASHION COLOR NYLONS SUDAFED TABLETS Anhistmine . a t .. . : paoMln--Iow8'atth 80..0124 -O'oprfng '88Iona ... .. .,,,.., .. .. 156 Complaint 'IEXHIBIT----.D HOspitlloS'A$8 m C--..r-hll w-as. -.J_c-, dI'".."".Il&.tl..c..w "'''' u.C""kC...,...",.." "'''Y' c..ti Ac Bo WQ"ld;o.otht_y"'...... ,.,,104 (or 1M .. - .w1I fon 10 ..,t. I.. 'I. ""I. o.icl 1......... I by.. ",\,01 u.!I I\ u" aI m. ow' s most ;nwitn pain re IBUPROFEN 200 mg.

now available without prescription at Walgreens 'NTIIDINGAdvi)adanced medicine for pain Ada i. Ibi 'Iii foed fowith1M jnsuptio' hail.,..

0I2.'D1...

500"00 An anti-Inflammatory Clnd an analgesic, Adve I' a source.

of comfort for p pl. who experience aJ1hritls pain.

No".nGltl Mvn of." 8fec rew fo th discmf of he.pain co. "" co It to.hM ta an cn _Zl_- First there was ospi in.

Now there is Advi :.:...::::::$...:: :!:?:::.:, .. ?:: : .;::::::::,:.::: ;( . ;:;.: ..: :: :::::::;: .:.:; :::::::?:::_:;:; : ! ; : . ,, ??::: : . ... ; . . 162 FEm;RAL TRADE COMMISSION DECISIONS Complaint 109 F.

EXHIBIT E AC'"" .00 1N"rtl: ;;Oad. =--.c L scc 0'' 3' C!-3";C-2'3rer;a CL:ENT WA:C::EN5.' 5LIl1- 5'! :\..TE 5/26: ' ::YU :. ::li;I-r2st DIO JCaOESGII"rrQ04 . ::': .1. .3:::." JPY Sc:L;:: \o?" 27Q- THURSD. . Y f. FRrDA '( GRE(NS lC EEO :59 U!olJEP. - NN':P. :f.' 'iLOU rn'.j':? ':7'. e. c= :::e ltr MU::1C JNtE e:- 2;?OG. :" e'''s :J= ?a: =: S .:' 5 s.::: ":eC: .,a:.:1 ::e:!:.ave::s-- ::or.. ::) =::ll:: :1S as lb =&f=:: - - :"3 n availa le a ?::e5 C=:':J::''::\ . :;:t Wal ==e.:-s jo'. ::0''' ;:a:- ;.. ct -::C:::

the: br2:":: r.a.e DVIl. 3people. !2- h u. -- - OY'- - .. lader ll fo:: t eITo=a re: ef of o= artt= t(z ?a:. es an :oo: .. =I' s;;:'e a:-. ":a.::Kac a!". Co =e::s:-:..a:; C=3lS. .UVIL : e==2:: :.ve, or. -:"a-=:::: : . a.::"- :":::::'a--=a:::::: ?a:.:- =e:':.e';e=. APVn. ava:.:; le ::u ?-=2SC= :.on. a: Wa:'g-=ee::s! :::se .:e::.;::.

.;e:= :: :e:

=!!=..s '::::s. a: ::: ::::se e': :. "'=5 -:::-: a. ==a.:: :as: g S a. : ::::a a :: ::::::a.:e ::::t: :;e:t .. a..: a. =- ::::e:a= ::== =::=::a. '-!!=7 s: e:: S.: =ea. :"5 c ::e== =-e -\:: :Jia: i., .::.::e. a.c. ==a: s:::- Ceo:: =.:::.:::a:7 c c=s c':o es: ;c. S-.. =_\57 .-= , 156 Decision and Order DECISION AND ORDER The Federal Trade Commission having initiated an investigation of certain acts and practices of the respondent named in the caption hereof, and the respondent having been furnished thereafter with a copy of a draft of complaint which the Bureau of Consumer Protection proposed to present to the Commission for its consideration and which, if issued by the Commission, would charge respondent with violation of the Federal Trade Commission Act; and The respondent, its attorneys, and counsel for the Commission having thereafter executed an agreement containing a consent order, an admission by the respondent of all the jurisdictional facts set forth in the aforesaid draft of complaint, a statement that the signing of said agreement is for settlement purposes only and does not constitute an admission by respondent that the law has been violated as alleged in such complaint, and waivers and other provisions as required by the Commission s Rules; and The Commission having thereafter considered the matter and having determined that it had reason to believe that the respondent has violated the said Act, and that complaint should issue stating its charges in that respect, and having thereupon accepted the executed consent agreement and placed such agreement on the public record for a period of sixty (60) days, now in further conformity with the procedure prescribed in section 2.34 of its Rules, the Commission hereby issues its complaint, makes the following jurisdictional findings and enters the following order:

1. Respondent Walgreen, Co. is a corporation organized, existing and doing business under an by virtue of the laws of the State of Ilinois, with its offce and principal place of business located at 200 Wilmot Road, Deerfield, Ilinois.

2. The Federal Trade Commission has jurisdiction of the subject matter of this proceeding and of the respondent, and the proceeding is in the public interest.

ORDER It is ordered, That respondent Walgreen Co. , a 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 ofC!Advil Nuprin" or any other over-the-coun- Decision and Order 109 F. ter analgesic drug product, in or affecting commerce as Hcommerce is defined in the Federal Trade Commission Act, do forthwith cease and desist from representing in any manner, directly or by implication:

A. That any such product can be substituted by consumers, in overthe-counter dose levels, for a prescription form ofthe product, because when so substituted such product provides all ofthe same therapeutic benefits to consumers as the FDA-approved label indications for the prescription form of the product, unless at the time of making the representation respondent possesses and relies upon a reasonable basis substantiating such representation. Except as otherwise permitted by the provisions of paragraph IV hereinbelow, such reasonable basis shall consist of at least two adequate and well-controlled doubleblinded clinical studies which conform to acceptable designs and protocols and are conducted by different persons independently of each other. Such persons shall be qualified by training and experience to conduct such studies.

B. That any such product provides anti-inflammatory benefits for arthritis or other conditions unless at the time of making the representation respondent possesses and relies upon a reasonable basis substantiating such representation. Except as otherwise permitted by the provisions of paragraph IV hereinbelow, such reasonable basis shall consist of at least two adequate and well-controlled double-blinded clinical studies which conform to acceptable designs and protocols and are conducted by different persons independently of each other. Such persons shall be qualified by training and experience to conduct such studies.

II.

It is further ordered That respondent, 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 Advil " uNuprin " any other over-the-counter analgesic drug product containing ibuprofen, or any other analgesic drug product existing simultaneously in over-the-counter and prescription forms, in or affecting commerce as "commerce" is defined in the Federal Trade Commission Act, do forthwith cease and desist from representing in any manner, directly or by implication, that any such product is effcacious for any purpose unless at the time of making the representation respondent possesses and relies upon a reasonable basis substantiating such representation. Except as otherwise permitted by the 156 Decision and Order provisions of paragraph IV hereinbelow, such reasonable basis shall consist of at least two adequate and well-controlled double-blinded clinical studies which conform to acceptable designs and protocols and are conducted by different persons independently of each other. Such persons shall be qualified by training and experience to conduct such studies.

III.

It is further ordered That respondent, 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 Advil " HNuprin" or any other over the-counter analgesic drug product containing ibuprofen, in or affecting commerce as commerce is defined in the Federal Trade Commission Act, do forthwith cease and desist from representing in any manner, directly or by implication, any performance characteristic of any such product (other than those covered by paragraphs I and II hereinabove) unless at the time of making the representation respondent possesses and relies upon a reasonable basis consisting of competent and reliable scientific evidence which substantiates such representation. Except as otherwise permitted by the provisions of paragraph IV hereinbelow, evidence shall be considered "competent and reliable" only if it consists of tests, experiments, analyses, research, studies, or other evidence conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession or science to yield accurate and reliable results.

IV.

The following provisions apply to paragraphs I through III of this order:

A. The term "analgesic drug product" means an oral dosage form of drug as to which the label indications for over-the-counter use are limited to the relief or reduction of pain, inflammation and/or fever. B. If FDA promulgates any final standard or any FDA Advisory Review Panel has in effect findings and conclusions establishing that such representation is true, such final standard or findings and conclusions (as long as they remain in effect) shall also constitute a reasonable basis for such representation.

Decision and Order 109 F. It is further ordered That respondent, its successors and assigns, for at least three (3) years after the date of the last dissemination ofthe representation, shall maintain and upon request make available to the staff of the Commission for inspection and copying: 1. All materials possessed and relied upon to substantiate any claim or representation covered by this order. 2. All test reports, studies, surveys, or demonstrations in their possession or control or of which they have knowledge that contradict qualify or call into question any representation covered by this order. VI.

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

VII.

It is further ordered That respondent shall forthwith distribute a copy of this order to each of its operating divisions. VII It L, further ordered That respondent shall, within sixty (60) days after the date of service of this order, fie with the Commission a report, in writing, setting forth in detail the manner and form in which it has complied with this order.

Chairman Oliver was recorded as voting in the negative. 167 Complaint