kathryn j. aikin, ph.d. division of drug marketing, advertising and communications

Direct-to-Consumer Prescription Drug Advertising in the United States: Background, Research, and the Current Environment

Kathryn J. Aikin, Ph.D.Division of Drug Marketing, Advertising and Communications

US Food and Drug AdministrationInternational Seminar on Drug Advertising

Brasilia, BrazilApril 5, 2005

Overview of Talk

Legal Requirements Types of DTC Evolution of DTC “Adequate Provision” in Broadcast Ads General Considerations in DTC Basis for Enforcement Actions FDA Survey Research Findings Current Environment and Recent

Enforcement Actions

Jurisdiction/Legal Basics

No laws or regulations ever prohibited promoting prescription drugs to consumers (in general or for specific products or drug classes)

Regulatory focus is on the content of the materials NOT their general existence

Jurisdiction/Legal Basics

Law prohibits requiring preapproval of any ad except under “extraordinary circumstances”

-- post hoc monitoring process

-- still, many manufacturers voluntarily request our comments prior to use

Requirements for Ads

Per FDA regulations issued in late 1960’s, ads: Must not be false or misleading Must present “fair balance” between benefits

and risk information Must disclose “material” facts in light of claims

made about product

What Does this Mean?

Accurately communicate indication(s) including context for any claim

Communicate most important risks in a manner reasonably comparable to benefits (presentation and language)

Cannot omit important information

In plain language this means Ads must communicate an accurate and balanced picture of the drug product

Some Sources of Product-Specific Health Information for Patients Healthcare Provider Patient Package Insert Advertising Brief Summary Internet Other Sources

Disease Awareness

Reminder

Product Claim

How DTC Evolved

Up to 1980’s: consumer communications through “learned intermediary”

1980’s: saw 1st DTC ads and fallout

--1983-1985: FDA voluntary moratorium

--1985: lifted, regulations provide “sufficient safeguards to protect consumers”

1990’s: print ads proliferated mid 1990’s: broadcast ads enters mix

Addressing “Adequate Provision”

Guidance (1997 draft; 1999 final) no change to regulations provided one possible interpretation of

“adequate provision” given current technology and marketplace

Reinforces underlying requirements Encourages consumer-friendly information

“Adequate Provision”

Assuming diverse audience, need multiple sources of product information toll-free telephone contact number website address concurrently running print ads reference to health care providers

Types of DTC Promotion

Disease Awareness Reminder ads/labeling Product claim


Disease Awareness disease discussion … “see your doctor”... consistently encouraged,

important for under-diagnosed, under-treated health conditions not drug ads, so not covered by FFD&CA recent draft guidance clarifies FDA’s position on these types of ads


Reminder ads/labeling exempted from risk disclosure requirements includes product name, but no representations

beyond dosage form, packaging, price info not for products with especially serious

(boxed) warnings


Product claim claims or representations trigger disclosure

requirements for accuracy and balance risk disclosure requirement in regulations

“brief summary” for print ads “adequate provision” for broadcast ads full product labeling for promotional labeling

General Considerations in DTC Advertising Accurate communication of indication(s)

Limitations on indication(s) Relevant patient population Concomitant therapies/treatments

Likelihood of benefit(s)

General Considerations in DTC Advertising

Disclose Most Important Risks “In brief summary” for print ads “Major” risks for broadcast ads + “adequate provision”

Boxed warnings Bolded warnings Significant precautions/drug interactions Frequent & significant side effects Contraindications (relevant to patients)

Risk Disclosure

Print ads need information “in brief summary” about risks and effectiveness most important risks comparably prominent to

effectiveness claims as “fair balance” Regulations require that print ads must

disclose all risks February 2004 Draft Guidance provided

alternatives to the current “brief summary” in effort to have information better conveyed to consumers

Risk Disclosure

Broadcast ads need: most important risks disclosed in ad itself (in

audio at least) “major statement” access to either all risks or “adequate provision”

for disseminating product labeling (PI)

General Considerations in DTC Advertising

“Fair Balance” of Risks and Benefits Prominence of the presentation Amount of information Language

Necessary context for benefit claims/risks Should not undermine the role of the healthcare

provider Disclose prescription status

Additional Considerations in Product Claim Ads

Overstatement of efficacy, especially if relatively low “freedom from,” “controls,” “proven

protection,” graphics suggesting significant impact, other hyperbole

sometimes context can help, other times it can’t

Implied unsubstantiated outcome claims “relaxed,” “confident,” “changed my life”

Additional Considerations in Reminder Ads

Avoid anything --verbal or visual -- that makes a claim about the product, e.g., “why suffer through another day?” “most prescribed of its kind” implied fixing of something that is broken clear suggestion of improved quality of life clear suggestion of patient population (all children, all

women, all people with some problem) reference to particular type of specialist

Common Problems in Proposals and Final Submissions Minimization or lack of risk information

missing content presentation (minimization, comparability)

Misleading communication of the indication or overstatement of efficacy

Unsubstantiated comparative claims Misleading visuals and graphics Distracting modalities or illegible SUPERs Rx status or role of healthcare provider minimized Inadequate mechanism for ensuring dissemination

of product labeling

Does DTC advertising...

Increase demand for advertised drugs? Cause patients to pressure doctors for

advertised drugs? Cause inappropriate prescribing? Increase the price of drugs or the cost of health

care? Harm the relationship between patients and

doctors? Is DTC advertising appropriate at all?

FDA Surveys

Look more closely at impact of DTC advertising on doctor-patient relationship Two consumer surveys (1999 and 2002) One physician survey (2002)

1999 and 2002 Consumer Surveys: Methodology 1999 National probability

sample conducted by telephone interview

1,081 respondents, 960 who had visited a doctor in the last three months for a problem of their own

2002 National probability

sample conducted by telephone interview

943 respondents who had visited a doctor in the last three months for a problem of their own

2002 Physician Survey: Methodology

Random Sample from American Medical Association Physician Masterfile

250 General Practitioners 250 Specialists in areas targeted by DTC

Dermatology Allergy/Pulmonology Endocrinology Psychiatry

Does DTC advertising increase demand for advertised drugs? DTC not primary driver of visits to doctor DTC plays a role in generating questions for

doctor Patients still use their doctors as #1

information source when looking for more information about a drug or treatment Pharmacists, nurses also highly ranked as

sources

Does DTC advertising cause patients to pressure doctors for advertised drugs?

Some patients do expect a prescription because of a DTC ad

Asking about prescription drugs constant across time Brand-specific requests are likely to be

accommodated Patients who ask about a brand are more likely to be prescribed that

brand than patients who ask in general General Practitioners are more likely to prescribe a requested brand

than Specialists General Practitioners report feeling more pressured to prescribe

Does DTC advertising cause inappropriate prescribing? Vast majority of patients who ask about a

brand have the condition that drug treats Among physicians who did not prescribe

requested drug, most common reasons were: drug not right for patient different drug more appropriate

Does DTC advertising increase the price of drugs or the cost of healthcare? Patients rarely discuss cost of drugs with

doctor Certain groups are more likely to discuss cost:

Women Patients in poor health Patient taking one or more prescription drugs Patients without prescription drug payment plan

Does DTC advertising harm the relationship between patients and doctors?

Patients report their doctors generally respond positively to questions

Greater percentage of doctors say patient having seen a DTC ad had positive impact on interaction, as opposed to negative impact

General Practitioners report more negative beliefs about potential negative effects of DTC ads than Specialists Physicians are evenly divided in opinions about overall impact of DTC ads on

patients and practice- 1/3 positive, 1/3 no effect, 1/3 negative General Practitioners report a more negative overall impact of DTC ads on

patients and practice than Specialists

Is DTC advertising appropriate at all?

DTC ads increase awareness of possible treatments

DTC ads do not convey information about risks and benefits equally well Physicians believe patients understand benefits

much better than risks Physicians believe DTC ads confuse patients about

relative risks and benefits of drugs Patient attitudes about many aspects of DTC

advertising have become less positive over time

Current Environment

Continued increase in DTC promotion spending

Concern about changing tone in ads Concern about presentation of risks

Are the winds of change on the way?

Number of Disseminated Promotional Pieces Submitted 2003 and 2004

6.9084.4238.417

6.059

37.52632.022

52.848

38.081

0

10.000

20.000

30.000

40.000

50.000

60.000

2003 2004

Mixed Consumer Professional Total

Number of Broadcast Ads Submitted1999-2004

143163191

128

201188

485

311295248242

105

628

474486

376

443

293

0

100

200

300

400

500

600

700

1999 2000 2001 2002 2003 2004

Proposed Disseminated Total

Draft Brief Summary Guidance

Regulations require that the “brief summary” include “each specific side effect and contraindication” (i.e., all risk concepts)

Manufacturers historically complied by reprinting risk-related sections of product labeling

Verbatim reprinting is not required Draft guidance describes consumer-friendly options

for brief summary in DTC ads

Enforcement Actions

Kaletra Untitled Letter Taxotere Warning Letter Seasonale Untitled Letter

Kaletra Untitled Letter

Print ad and restroom poster Indicated for use in combination with other

antiretroviral agents for the treatment of HIV-infection

Contraindications Warnings

Kaletra Print Ad

Kaletra Untitled Letter

Ad and poster did not contain the indication or risk information

Not aware of substantial evidence to support 5-year claims for: survival good health undetectable HIV RNA levels disease control

Taxotere Warning Letter

Three DTC print ads Limited indications for certain types of breast

and lung cancer Boxed warning for severe and potentially life-

threatening adverse reaction


Overstated survival benefits: Headline: “The next move may be the key to survival” Proven survival differences were at best several

months and were only observed in specific populations Other drugs with proven survival benefits

Unsupported outcomes claims Stay involved in important aspects of your life


Omission of risk information Boxed warning information on risk of life-threatening

infections, severe allergic reactions, and severe fluid retention

Certain common side effects

Minimization of risk information Risk info lacked visual prominence Disclosure began “Like all anticancer agents, there

are side effects…”

Seasonale Untitled Letter

Product claim TV ad Indicated as an extended-cycle OC

91 days: 84 active tablets and 7 inert Warnings

The usual OC warnings plus Bleeding irregularities: “the convenience of fewer

planned menses (4 per year instead of 13) should be weighed against the inconvenience of increased intermenstrual bleeding and/or spotting”

Warning also contained in patient labeling


Failure to reveal material facts in light of the claim “4 periods a year” Patients using Seasonale may experience

breakthrough bleeding or spotting for up to one year Breakthrough bleeding may be up to the amount

similar to a regular period Total days of bleeding and spotting are similar in

number for Seasonale subjects as for those on conventional OCs


Minimization of risk Suggested there was a consensus

among medical experts that there are no adverse health effects of having only four periods a year

Competing visuals Fast-paced scene changes Other competing modalities, such a

background music and SUPERS

Where to Find Recent Guidances

Consumer-Directed Broadcast Ads: http:// www.fda.gov/cder/guidance/1804fnl.htm

“Help-Seeking” and Other Disease Awareness Communications: http://www.fda.gov/cder/guidance/6019dft.pdf

Brief Summary: Disclosing Risk Information in Consumer-Directed Print Ads: http://www.fda.gov/cder/guidance/5669dft.pdf

Other Online FDA Resources

General FDA information: http://www.fda.gov

DDMAC home page: http://www.fda.gov/cder/ddmac.htm

Untitled and Warning Letters: http://www.fda.gov/cder/warn/index.htm

Contact info: [email protected]

kathryn j. aikin, ph.d. division of drug marketing, advertising and communications

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