1	The Consumer HealthCare Products Association and FDA present The OTC Drug Seminar Series Over-the-Counter and On-the-Air The Advertising of OTC Drug Products
2	Co-sponsorship Agreement Consumer HealthCare Products Association (CHPA) and Food and Drug Administration
3	Steering Committee Sandy Barnes, FDA Greg Collier, P&G Robert Eshelman, FDA Mark Gelbert, Pfizer David Hilfiker, FDA Susan James, GlaxoSmithKline Iris Khalaf, FDA Karen Lechter, FDA Lorna Totman, CHPA Mitchell Weitzman, FDA
4	Purpose To promote a better FDA and industry understanding of the unique challenges in the present and future OTC healthcare environment.
5	FDA-CHPA Seminar Series Over-the-Counter and On-the-Air The Advertising of OTC Drug Products May 13, 2004
6	Advertising of OTC Drug Products Planning Committee Leah Cutter, Ph.D Regulatory Health Project Manager, Division of Over-the-Counter Drug Products Doreen Frank Associate Director Regulatory Affairs, Schering-Plough Janice McSherry Assistant General Counsel, GlaxoSmithKline Paul Sturman Sr. Vice-President Marketing, Pfizer
7	Over-the-Counter and On-the-Air The Advertising of OTC Drug Products Welcome - David Hilfiker Introduction and Seminar Objectives - Doreen Frank Advertising “101” - Paul Sturman Advertising Claims - Going Beyond the Label - Janice McSherry Advertising Review and Approval Process - Doreen Frank 15 minute Break Advertising Self-Regulation: It’s Role in Food, Drug and Dietary Supplement Advertising - Andrea Levine FDA’s Role in OTC Advertising and Promotion - Leah Cutter FTC’s Role in OTC Drug Advertising - Mary Engle Q & A Closing Remarks - Mark Gelbert
8	Over-the-Counter and On-the-Air The Advertising of OTC Drug Products Seminar Objectives Understand how industry develops, supports, approves and executes advertising to support their OTC drug products. Discuss FDA, NAD and FTC’s role, policies and procedures as they relate to maintaining truth and accuracy in OTC drug advertising.
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11	Why Advertise? Has always been a good way to inform; Introducing a new product Suggesting new uses for a product Explaining how a product works Correcting false impressions Persuade; Building brand preference Encouraging switching Changing buyer perceptions of product attributes Remind. Top of mind awareness Where to buy Seasonal/ off-season
12	"Classic TV examples" Classic TV examples
13	Types of “Advertising” Mass Media Broadcast Television, radio Print Newspapers, magazines Display Billboards, signs, posters Event Marketing Press conferences, exhibits, tours, grand openings Direct Marketing Direct Mail, Catalog, Telemarketing, DRTV, Internet/On-line
14	The Advertising Development Process Complex 12-18 mos. process with multiple checks & balances Substantial media budgets (>$25MM) are built to reach ~80% of the target audience over 4 times for an average 4 week period.
15	The Advertising Development Process
16	Importance/process of “Consumer Insight” Changing buying behavior requires a deep understanding of the consumer’s underlying wants, needs, and current behaviors “Benefit of the benefit” The emotional component of this connection between brand and consumer should not be underestimated Unique learning techniques such as adcepts and anthropological research are important tools in this exploration.
17	"Anthropological research Skin/UR" Anthropological research Skin/UR
18	The Advertising Development Process
19	Why do we test Advertising before we go to production and on-air? Insure that we are meeting communication objectives. Insure no unintended, misleading communication. Insure that we are providing a relevant message that results in a positive change in buying behavior. Mitigate risk of costly production. Enhance probability of positive in-market results and avoid of wasteful media spend.
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21	What do we measure before we go on-air? Brand Recall How good is the commercial at getting you to remember it a day after viewing? Persuasion How motivating is the commercial at changing your attitude towards considering a brand after seeing it? Main idea/product attribute playback and “likeability”
22	So what does “Best in Class” look like? Advertising that scores above norms within its respective category across several key measures, particularly brand recall and persuasion (intent to purchase). Advertising that “scores” positive change with consumer behavior in the marketplace.
23	The Advertising Development Process
24	"Approved ingredients (NDA," Approved ingredients (NDA, monograph, cosmetic) are basis for claims Certain categories have additional “approvals” required, e.g. ADA Strict requirements around product usage (as directed, do not exceed) and product labeling Bigger creative challenge as people are not well (no big promise).
25	How is OTC Advertising specifically different from DTC Advertising? FTC regulates OTC advertising while FDA regulates DTC advertising. Brand preference in an existing need state/condition DTC needs to educate about a disease state Establish sickness, involve intermediary, possible brand solution
26	In summary, what makes for “Best in Class” Advertising”?
27	Example: Natural Citrus Listerine Clearly defined objective and target Convince non-users of mouthwash to try New Natural Citrus Listerine Strategy that differentiates All the germ killing power of regular Listerine with a new taste that is less intense Leverages important consumer insight People generally know that Listerine is effective, but some don’t use it because they find it too strong. Key Challenge Speak to non-users about the “downside” of using regular Listerine WITHOUT disparaging the base franchise
28	"Natural Citrus Listerine ad" Natural Citrus Listerine ad
29	Advertising Claims Substantiation . . . Going beyond the Label Janice McSherry Assistant General Counsel GlaxoSmithKline Consumer Healthcare May 13, 2004
30	Claims Substantiation: Many Hurdles Regulatory Compliance Federal Trade Commission Food & Drug Administration Legal Approvals Company Policy Trademarks, Copyrights Legal Precedence Litigation Risk Network Standards Voluntary Codes Medical Appropriateness Scientific Validity Typicality Marketing Goals Consumer Acceptance and Persuasion Competitive Strategy Internal Approvals External Clearances Senior Executives
31	Basic Considerations Companies like ours are serious when it comes to advertising claims support Most have cross-functional teams comprised of Regulatory, Medical, Legal and Brand Managers among others to review claims and support Whether an ad is fully substantiated is never a certainty The decision to air is ultimately made by senior managers assessing risk against benefit to business in consideration of all viewpoints
32	So, Why Worry? What if We Are Wrong? Failure to have robust substantiation for the commercial may result in serious, costly and even unlawful consequences: failure to gain network approval challenge by a competitor regulatory inquiry by the Federal Trade Commission State Attorneys General the Food and Drug Administration litigation by a public interest group or class action attorney The most common serious consequence is the disruption of the ad campaign
33	The FTC sets the Foundation National advertisers must meet the FTC standard of truthful and not misleading advertising claims All material claims must be substantiated by a reasonable basis of support Health-related claims require the highest level of reliable and competent support because consumers cannot always judge product performance for themselves Advertisers must have evidence to back up their claims Establishment claims that mention a test or survey must have that specific support The ads cannot make unfair comparisons
34	We Look to the Label The product label can guide a review team as it determines a reasonable basis for the claim support The risk often correlates to the product’s regulatory status: NDA “Switch” Drug and labeling had the most rigorous review Monograph OTC Drug contains an approved active ingredient Approved Device Approved Cosmetic Ingredient Dietary Supplement -no regulatory review of label claims However, ad claims are not limited to label claims
35	Different Forms of Claims Express claims are direct statements “relieves heartburn” “stops headache pain” Implied claims are inferred, usually by context “relieves heartburn . . . so you can enjoy life” “stops headache pain . . . so that you can get a good night’s sleep” Potential over-promising of speed or quality of life benefits Puffery is an exception - no substantiation required claims that a consumer would not take seriously such as hyperbole or subjective statements “freshness that just won’t quit” “aisle 5 is full of Sudafed”
36	Different Types of Claims Monadic claims pose the lowest risk “Tums relieves heartburn” “Polident works overnight” Comparative claims create uncertainty Superiority claims increase risk of challenge “Tums neutralizes acid faster than Zantac or Pepcid” “Sensodyne is the #1 Dentist-Recommended Brand” Parity claims can be the riskiest “No calcium is better absorbed” “Nothing works faster” Can be interpreted as implied superiority claims
37	Levels of Risk and Types of Claims
38	Other Things to Worry About: Beyond FTC’s reasonable basis requirement, companies must assess these risks and hurdles: Nature of the product and the strength of the underlying science Industry Voluntary Codes and Guidelines Network Clearance Litigation Risk The competitive environment and the likelihood of challenge The relative value of the claims to the business Are these “throw away” claims?
39	The stronger the science, the less we worry. Product claims are not always clinically tested and may not have specific scientific support. Innovative product, or line extension? Custom testing or borrowed science? Clinicals or Lab tests? In-house studies, or peer-reviewed, published literature? Well-tested, typical use or novel and unknown? Approved indication or unique benefit? Accepted methods or proprietary technique? New survey or old data?
40	Network Review and Approval 4 major and many cable networks have Broadcast Standards Departments published guidelines apply to TV and radio “white coat” restriction “follow label directions,” “occasional use” requirements Review of storyboards first, then finished ads Formal Challenge Process note: Federal Communication Commission sets decency standards but does not regulate advertising for programming between 6 a.m.-10 p.m. exceptions: children’s programming and political advertising
41	Will We Be Challenged? And Will We Win? There are many potential plaintiffs. A reliable review process should anticipate challenges from: Regulatory authorities Competitors Consumers Public interest groups Class action attorneys
42	Is it Worth the Worry? National advertisers of OTC Drug Products expend substantial resources to ensure that they deliver truthful and not misleading advertising that complies with the numerous requirements discussed here Companies rely heavily on their Review Teams to assess the risk of each product claim against the benefit to the business To that end, most companies have established procedures to make the analysis a bit more reliable and less worrisome
43	Advertising Review and Approval Industry’s Process Doreen Frank Associate Director, Regulatory Affairs Schering-Plough HealthCare Products May 13, 2004
44	Purpose of the Advertising Review and Approval Process Process ensures compliance with all applicable laws, regulations, and guidelines, as well as internal company policies Process ensures all claims are adequately substantiated All OTC drug advertising is reviewed and approved by an appointed committee - a core group consisting of Law, Medical, Regulatory and Marketing
45	Advertising Review Committee Meets regularly, often weekly, to review advertising Each Committee representative is responsible for reviewing the advertising with respective to their area of expertise prior to the meeting
46	Advertising Review Committee At the meeting - the Committee reviews materials and collectively: provides an assessment on the adequacy of claims substantiation advice on such items as proper wording of claims, likely net impression of claims, tonality, and “taste” of the material ensures conformance to laws, regulations, guidelines, and internal standards of conduct reviews materials based on legal/regulatory precedent (i.e. case law, NAD, FTC challenges)
47	The Advertising Review and Approval Process
48	Compliance with the Advertising Review and Approval Process Companies develop Corporate Policy and Procedures to ensure the review of all advertising through a defined process Companies also develop Standard Operating Procedures (SOPs) to make sure the process is followed A formalized training program is established for all users All advertising material must be approved by the Committee (or Committee Representative) prior to dissemination to the consumer and/or healthcare professional
49	Partnering with our Advertising Agencies Industry works closely with Advertising Agencies to ensure that all advertising pieces are reviewed and approved through the Advertising Review and Approval process Additional procedures and guidelines are often developed to assist the Advertising Agencies Training sessions are provided to the Advertising Agencies allowing account representatives to understand the Company’s internal process
50	Summary - Industry Practices Advertising “101” Development Process Consumer Insight Multi-disciplinary Effort Advertising Claim Substantiation Claims Substantiation - Requirements Different Types of Claims Advertising Review and Approval Process
51	Advertising Self-Regulation: It’s Role in Food, Drug and Dietary Supplement Advertising Andrea C. Levine, Director National Advertising Division
52	NAD’s MISSION To protect the integrity of advertising by ensuring that claims are truthful and accurate Discourage unnecessary government involvement in advertising
53	Who Benefits? Consumer confidence increases Advertisers can govern themselves Quick dispute resolution Level playing field Cost effective alternative to litigation Frees up government resources
54	National Advertising Division Jurisdiction over advertising that is: Targeted to adults (over 12) “National in scope” Objectively provable claim Print Packaging & labels Broadcast: TV, radio, infomercials Direct Mail Internet
55	NAD’s Standard Advertising must be truthful, accurate and not misleading What is the message conveyed? What is the support? Is there a good fit?
56	Different Role Than Government No Wrongdoers/No Punishment Decisions Guide & Educate Can Rebut Reasonable Basis - Evidence Materially Flawed - Better Evidence: Different Result
57	Why Do Companies Participate? 96% voluntary compliance rate No “enforcement power” Referred cases go the the top of FTC’s pile (FDA, FCC, DOT, State AG’s) Slim America ($8.3 Million judgment) Many elect to return to voluntary self-regulation
58	The Review Process Relatively simple process Two rounds of submissions Ex parte meetings with scientists and experts Published decision in about 4-5 months Detailed analysis—fair hearing (116 appeals) Appeals to NARB
59	NAD Case Reports Brilliant legal opinions Detailed summary of the parties positions In depth analysis of claim substantiation Conclusion: Substantiated, Modify or Discontinue Subscribe www.nadreview.org
60	What’s the Message? Advertising claims can be technically truthful But still misleading What is the “net impression”?
61	Does the Evidence Fit the Claims
62	Implied Claims Advertisers are obligated to support all reasonable messages conveyed by their advertisements Not just the messages they intended to convey Extrinsic evidence not necessary
63	Puffery and Implied Claims
64	Puffery Vague, fanciful, hyperbolic claims that consumers are unlikely to take seriously Claims not capable of verification or measurement No substantiation required An objectively provable claim needs proof Even if it is funny (Humor not always puffing) Even if you sing it (You may still need to prove it)
65	Anecdotal Evidence
66	Dietary Supplements
67	Rely on FDA Monograph
68	FDA Monograph
69	Product Demonstrations
70	FDA Approved Use Instructions
71	Product Denigration
72	Product Denigration NAD closely scrutinizes claims that denigrate a competitors product NAD’s handling of these claims differs from the courts The claim should be narrowly drawn, truthful, accurate and not misleading Humor helps--sometimes
73	Consumer Complaints
74	Monitoring Cases
75	Monitoring: Defer to FDA
76	D-T-C Rx Advertising NAD’s jurisdiction to review Rx advertising is concurrent with FDA’s Depending on the circumstances NAD will independently review the claims NAD will defer to FDA
77	NARB Appeal
78	Weight Loss Products
79	Partnering with FDA Back up and support- Slim America case Encourage advertisers to participate in the self-regulatory process Refer competitor challenges to NAD Follow up on our referrals
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81	"The information contained in these..." The information contained in these slides is not intended to announce new CDER policy or any change to existing CDER policy. The views and opinions expressed herein are my own and do not represent an official position on behalf of FDA.
82	Objectives How inquiries and complaints regarding OTC drug product advertising come to FDA FDA “review” process Interactions with FTC (Federal Trade Commission)
83	Complaints and Inquiries Received from: Competing companies Division of Drug Marketing, Advertising and Communications (DDMAC) CDER Ombudsman Consumers Received by: Division of Over-the-Counter Drug Products (DOTCDP) Office of Compliance
84	“Review” Process Advertising versus Labeling Case by case determination What is labeling? Legal definition in FD&C Act 201(m) “Labeling” “The term “labeling” means all labels, and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.” Physical attachment not necessary Textual relationship is significant
85	If it is determined to be… Labeling: Based on legal definition CDER Office of Compliance Advertising: FDA/DOTCDP reviews clinical data from trials Data supports claim Data makes claim false or misleading, or doesn’t support If claim(s) not supported by data, sent to FTC for their review and action
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87	FTC’s Role in OTC Drug Advertising Mary K. Engle, Esq. Associate Director Division of Advertising Practices Bureau of Consumer Protection
88	OVERVIEW Interaction with FDA Basics of FTC Advertising Law OTC Drug Enforcement
89	FTC/FDA Interaction Two agencies have overlapping authority over OTC drug marketing Longstanding liaison agreement FDA: Labeling FTC: Advertising Staffs of agencies coordinate closely
90	FTC Advertising Law Basics Primarily a law enforcement agency Broad liability: advertiser, ad agency, endorser … Wide variety of remedies: warning, injunction, refunds, disgorgement of profits, corrective advertising … Administrative or Federal courts
91	FTC Advertising Law Basics Section 5 of FTC Act: prohibits unfair or deceptive acts or practices An act or practice is deceptive if it misleads consumers acting reasonably under circumstances and is material to the purchase/use decision Section 12: prohibits any “false advertisement” that is “misleading in a material respect”
92	FTC Advertising Law Basics Two basic principles: 1. Advertising must be truthful and not misleading 2. Objective claims must be substantiated before they are made
93	FTC Ad Law Basics – Ad Meaning Apply a “reasonable consumer” standard Look at both express and implied claims: what is overall “net” impression of the ad There may be more than one reasonable interpretation of an ad Ad may need to disclose “material” information, i.e., info affecting purchase/use decision
94	FTC Ad Law Basics: Disclosures “Clear and conspicuous”* Prominence: Is it big enough for consumers to notice and read? Presentation: Is wording and format easy for consumers to understand? Placement: Is it where consumers look and near the claim it qualifies?
95	FTC Ad Law Basics: Disclosures
96	FTC Ad Law Basics - Substantiation Advertiser needs “reasonable basis” for claims before ad runs Depends on nature of claim: Type of product Type of claim Benefits of truthful claim and cost/feasibility of developing substantiation Consequences of false claim What do experts in the field expect
97	FTC Ad Law Basics - Substantiation Examples of increasing levels of substantiation: “Brand X comes in three delicious flavors” “4 out of 5 physicians recommend Brand X over Brand Y” “Brand X is an effective treatment for arthritis pain”
98	FTC Ad Law Basics - Substantiation Claims related to health and safety generally must be supported by: “Competent and reliable scientific evidence”
99	“Competent and Reliable Scientific Evidence” Tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.
100	FTC Ad Law Basics - Substantiation FTC relies heavily on FDA expertise to evaluate claims of drug safety and efficacy Flexible but rigorous standard (depends on how claim is qualified) No fixed formula Well-controlled clinical studies should always be starting point Anecdotal experiences are not science
101	FTC Ad Law Basics - Substantiation Evidence must be relevant to the product and the claim Population studied Dose/formulation Extent/nature/permanence of effect Certainty of science
102	FTC Ad Law Basics - Substantiation
103	Law Enforcement Actions - OTC Drugs The FTC traditionally has been active in bringing cases against deceptive OTC drug ads. Seminal FTC advertising law decisions involved claims for OTC drugs: Pfizer (1972) – substantiation principles; Thompson Medical (1984) – ad interpretation principles; Warner-Lambert (1977) and Ciba-Geigy (now Novartis) (2000) - corrective advertising remedy.
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105	Current Law Enforcement Activities The FTC has not brought many OTC drug consumer protection cases recently. Instead, major focus in recent years: dietary supplement and weight loss advertising.
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108	OTC Drug Advertising Monitoring FTC staff continues to actively monitor and investigate claims made in OTC drug ads, especially efficacy claims and claims that a drug has “no side effects.” For example, the Division of Advertising Practices maintains an OTC Drug Advertising Database to track information on a number of elements (such as major claims) of OTC drug ads.
109	Some Considerations in Assessing OTC Drug Cases Nature of claim: Does the deception relate to the drug’s efficacy or side effects? Can the consumer independently gauge whether the drug performs as advertised?
110	Some Considerations in Assessing OTC Drug Cases Does the deception cause consumer injury (health and/or economic): Is there injury to health if product does not worked as claimed? Will the false claims lead consumers to forgo more effective treatments? How widely was the advertisement disseminated? Does the product cost more than comparable products?
111	Illustrative Cases – Consumer Injury Bayer (consent order 2000): Unsubstantiated claims that regular use of aspirin is appropriate therapy for the prevention of heart attacks and strokes in the general population. Pfizer (consent order 1998): False and unsubstantiated claims for lice shampoo, e.g. clinical studies prove that the shampoo cures lice infestations in a single treatment. Ciba-Geigy/Novartis (litigated order 2000): Deceptive superiority claims for Doan’s pills; efficacy was comparable to other pain relievers, and Doan’s charged a substantial price premium over those products.
112	Some Considerations in Assessing OTC Drug Cases Is FTC action in the public interest? Is a claim likely to be challenged by a competitor under the Lanham Act? Has the NAD reviewed the claim? If NAD refers the ad to us, we give it a close look.
113	Future FTC Enforcement Activities: OTC Drug Advertising and Promotion The FTC staff will continue to monitor OTC advertising and bring cases to prevent consumer injury. What kinds of deceptive claims are the focus? Credence claims (where consumers can’t judge claims for themselves) Efficacy and safety claims Harm to consumers over harm to competitors
114	Future FTC Enforcement Activities: OTC Drug Priorities The staff will take a hard look at claims made when an Rx drug goes OTC because of the prospect that consumers will be misled or confused following the change. Difference in dosage Difference in indications Touchstone is consumer injury