Pfizer Inc.; Analysis To Aid Public Comment

FEDERAL TRADE COMMISSION

[File No. 972-3159]

Pfizer Inc.; Analysis To Aid Public Comment

AGENCY: Federal Trade Commission.

ACTION: Proposed consent agreement.

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SUMMARY: The consent agreement in this matter settles alleged

violations of federal law prohibiting unfair or deceptive acts or

practices or unfair methods of competition. The attached Analysis to

Aid Public Comment describes both the allegations in the draft

complaint that accompanies the consent agreement and the terms of the

consent order--embodied in the consent agreement--that would settle

these allegations.

DATES: Comments must be received on or before November 27, 1998.

ADDRESSES: Comments should be directed to: FTC/Office of the Secretary,

Room 159, 6th St. and Pa. Ave., NW., Washington, DC 20580.

FOR FURTHER INFORMATION CONTACT:

Linda Badger or Kerry O'Brien, San Francisco Regional Office, Federal

Trade Commission, 901 Market St., Suite 570, San Francisco, CA 94103.

(415) 356-5270.

SUPPLEMENTARY INFORMATION: Pursuant to Section 6(f) of the Federal

Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46 and Section 2.34 of

the Commission's Rules of Practice (16 CFR 2.34), notice is hereby

given that the above-captioned consent agreement containing a consent

order to cease and desist, having been filed with and accepted, subject

to final approval, by the Commission, has been placed on the public

record for a period of sixty (60) days. The following Analysis to Aid

Public Comment describes the terms of the consent agreement, and the

allegations in the complaint. An electronic copy of the full text of

the consent agreement package can be obtained from the FTC Home Page

(for September 18, 1998), on the World Wide Web, at ``http://

www.ftc.gov/os/actions97.htm.'' A paper copy can be obtained from the

FTC Public Reference Room, Room H-130, Sixth Street and Pennsylvania

Avenue, NW., Washington, DC 20580, either in person or by calling (202)

326-3627. Public comment is invited. Such comments or views will be

considered by the Commission and will be available for inspection and

copying at its principal office in accordance with Section

4.9(b)(6)(ii) of the Commission's Rules of Practice (16 CFR

4.9(b)(6)(ii)).

Analysis of Proposed Consent Order To Aid Public Comment

The Federal Trade Commission has accepted an agreement, subject to

final approval, to a proposed consent order from respondent Pfizer Inc.

The proposed consent order has been placed on the public record for

sixty (60) days for reception of comments by interested persons.

Comments received during this period will become part of the public

record. After sixty (60) days, the Commission will again review the

agreement and the comments received and will decide whether it should

withdraw from the agreement or make final the agreement's proposed

order.

Pfizer Inc. (``Pfizer'') markets a variety of over-the-counter

pharmaceuticals, including ``RID Lice Killing Shampoo.'' RID is a

shampoo (or ``pediculicide'') sold to treat people who suffer from head

lice infestations. The RID package includes a comb for use in removing

lice eggs. The Commission's complaint alleges the Pfizer's advertising

for RID included false and unsubstantiated claims that: (1) RID Lice

Killing Shampoo cures lice infestations in a single treatment; (2) the

RID egg removal comb is one hundred percent effective; (3) clinical

studies prove that RID Lice Killing Shampoo cures lice infections in a

single treatment; and (4) clinical studies prove that the RID egg

removal comb is one hundred percent effective.

In fact, the complaint alleges that RID is based on a pesticide

which is not one hundred percent effective against lice eggs. Consumers

should be aware of this limitation and make every effort to physically

remove lice eggs. In addition, when this type of pediculicide is used,

consumers are instructed to apply a second treatment in seven to ten

days to kill any newly hatched lice. In addition, the complaint

explains that the RID comb, included with the shampoo, is not

necessarily one hundred percent effective. Lice eggs are difficult to

see and to remove. The effectiveness of the comb is largely dependent

on the skill and tenacity of the comber.

The complaint further explains why clinical studies do not prove

that RID cures lice infestations in a single treatment. Specifically,

the complaint alleges that the study Pfizer relied upon to make this

claim included the application of a single treatment, along with a

thorough combing that removed all lice eggs. Moreover, the studies

relied upon the claim that the RID egg removal comb is one hundred

percent effective employed individuals trained in egg removal to comb

patients' hair. According to the complaint, there is no evidence that

the same results are achievable by an average consumer.

The proposed consent order contains provisions designed to remedy

the violations charged and to prevent the respondent from engaging in

similar acts and practices in the future. Part I of the proposed order

would prohibit the company from representing that RID Lice Killing

Shampoo or any substantially similar product cures a lice infestation

in a single application, unless the representation is true and, at the

time it is made, respondent possesses and relies upon competent and

reliable scientific evidence that substantiates the representation.

Parts II and III of the order require that, for a period of two

years, the company make disclosures in its advertisements anytime it

makes claims regarding the efficacy of RID or any substantially similar

product. Pursuant to Part II, the following disclosure will be required

in print ads and promotional materials: ``Reapplication and egg removal

are required to ensure complete effectiveness. See label for important

information.'' Part III requires the disclosure, ``Two Treatments

Required,'' be made in ads communicated through an electronic medium,

such as television. When the ad makes any claims regarding directions

for use of the product, this disclosure must be in the audio as well as

the video portion of the advertisement.

Part IV of the proposed order prohibits Pfizer from misrepresenting

the existence, contents, validity, results, conclusions, or

interpretations of any test, study, or research, for any drug or device

for the treatment of lice in humans, or any pesticide for treatment of

lice. Part V of the proposed order requires the company to have

scientific support prior to making any claims regarding the efficacy of

any drug or device for the treatment of lice in humans, or any

pesticide for treatment of lice. Because this matter involves a drug

regulated by the FDA, Part VI of the order includes a safe harbor

allowing the respondent to make any claim permitted under a new drug

application, or under a tentative final or final standard promulgated

by that agency.

The proposed order also requires the respondent to maintain

materials relied

[[Page 51583]]

upon to substantiate claims covered by the order; to provide copies of

the order to certain personnel of the respondent; to notify the

Commission of any changes in corporate structure that might affect

compliance with the order.

The purpose of this analysis is to facilitate public comment on the

proposed order. It is not intended to constitute an official

interpretation of the agreement and proposed order or to modify in any

way their terms.

By direction of the Commission.

Donald S. Clark,

Secretary.

Statement of Chairman Pitofsky and Commissioners Anthony and

Thompson

In the Matters of, Care Technologies, Inc., File No. 972-3136,

Del Pharmaceuticals, Inc., File No. 972-3084, Pfizer Inc., File No.

972-3159.

We write to express our view about the concerns Commissioner

Swindle raises regarding the disclosure remedy in these cases. The

orders require that, for two years, whenever a claim is made regarding

the efficacy of the lice removal products, the respondents include a

disclosure about the necessity for a second application of their

product. Commissioner Swindle is concerned that this amounts to

corrective advertising, and should not be imposed absent evidence that

consumers hold lingering misbeliefs.

Unlike corrective advertising that is designed to correct

misbeliefs caused by past advertising, the disclosure remedy in these

cases in fencing-in relief, designed to prevent purchasers of

respondents' products from being deceived by future advertising.\1\ The

triggered disclosure about the need for two treatments provides

additional assurance that consumers will not be misled by future ads.

We are satisfied that the triggered disclosures in these orders are

appropriate and reasonably related to the alleged violations of Section

5.

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\1\ It is also worth noting that the Commission has

distinguished triggered disclosures such as those in these cases

from corrective advertising, which is required regardless of the

contents of the ad. Removatron Int'l Corp., 111 F.T.C. 206, 311-12

n. 28 (1988), aff'd, 884 F.2d 1489 (1st Cir. 1989). See also

American Home Prods. Corp. v. FTC, 695 F.2d 681, 700 (3d Cir. 1982).

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Statement of Commissioner Orson Swindle

In the Matters of, Care Technologies, Inc., File No. 972-3136,

Del Pharmaceuticals, Inc., File No. 972-3084, Pfizer Inc., File No.

972-3159.

I have voted to accept these consent agreements for public comment

despite my reservations about the disclosure requirements. Advertising

for these lice treatment products has contained false and misleading

claims that the products can eradicate an infestation after a single

use. In truth, reapplication and careful combing are required to

complete the treatments. I have no doubt that the injunctive provisions

are needed and appropriate to address these misrepresentations.

The settlements, however, go further. Under the terms of the

consent orders, the respondents would be required for two years to

state, in any advertising for lice treatments that makes an efficacy

claim, that two applications of the treatment are necessary. The orders

would mandate this disclosure in addition to prohibiting the challenged

claims and requiring competent and reliable scientific evidence to

substantiate any representation about the efficacy of the products.

The disclosures cannot be justified as necessary to correct a

deception by omission. The orders prohibit the challenged claims and

require substantiation for future claims. Any representation--either

express or implied--that only one application will complete the

treatment would violate the terms of this order. The disclosures are

therefore not necessary to protect against false or misleading claims

about the efficacy of a single treatment.

The proposed consent orders in effect require that the respondents

include a corrective message in their advertising. We have no evidence

that the respondents' marketing substantially created or reinforced a

lingering misimpression about these products. Warner-Lambert Co. v.

FTC, 562 F.2d 749 (D.C. Cir. 1977), cert. denied, 435 U.S. 950 (1978).

The disclosure requirement cannot, therefore, be justified as

corrective advertising.

Fencing-in relief in a consent order could arguably require that

the respondent disseminate information to educate consumers. In these

cases, however, I fear that we are using our fencing-in authority to

justify what is actually corrective advertising. If we cannot meet the

standard for imposing this relief as corrective advertising, let us not

try to camouflage it as fencing-in.

I support the Commission's move toward stronger remedies. In this

case, the injunctive provisions, together with the FDA-mandated

labeling,\1\ should ensure that consumers have truthful and accurate

information before and after purchase. The disclosure requirement,

however, is superfluous and the facts do not justify corrective

advertising.

\1\ The FDA requires the following statement on the label of any

shampoo formulated to treat head lice:

Apply to affected area until all the hair is thoroughly wet with

product. Allow product to remain on area for 10 minutes but no

longer. Add sufficient warm water to form a lather and shampoo as

usual. Rinse thoroughly. A fine-toothed comb or special lice/nit

removing comb may be used to help remove dead lice or their eggs

(nits) from hair. A second treatment must be done in 7 to 10 days to

kill any newly hatched lice.

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[FR Doc. 98-25846 Filed 9-25-98; 8:45 am]

BILLING CODE 8010-01-M