Regulatory & Public Health Implications of DTCA

Economists ConferenceLouis A. Morris, Ph.D.

April 29, 2003

AARP Bulletin, March 2002

AARP Bulletin, March 2002

FDA Is Inundated TryingTo Assess Drug Ad Pitches

More Than Ads, Drug MakersRely on Sales Representatives

Ad Agencies Begin to ParticipateIn Development of New Drugs

Backlash Rises Against Flashy AdsFor Prescription Pharmaceuticals

European Drug Makers May UtilizeMore Aggressive Marketing Tactics

March 14, 2002 March 13, 2002

FD&C Act - 1962 Amendments

Advertisements and Labelingmust contain a true statement of the drug’s intended uses cannot be false or misleadingmust contain a brief summary

Regulationsfair balance

contextualoverall

DTC Policy “Change”Draft Guidance - July, 1997

comment period closed October, 1997

Adequate Provisiontoll free telephoneconcurrent print or other availabilityHCP (MD, RPh, Vet.) provide informationInternet

Presumes Major Statement

FDA Letters: 8 Pitfalls of DTCA

Reminder/Institutional Implied ClaimsDisclosure AdequacyContextual Fair Balance Limits on EffectivenessOverall Fair BalanceUnsubstantiated ClaimsDistractions

“RID the CLOUD”

2002 DDMAC LettersN = 27

DTC Objections 9Medical Meeting 5

Oral Statements 3Oral Statements at Hosp 1

Outcomes Claims 2Web – Pre-approval 1

Down from over 100 letters in previous years Seems like the same mix of topics

2002 DTC AdsMedia

TV/Radio 5Print 4Telephone 1

FDA ObjectionLack of Risk Info 3Misleading Implications 4Fact-Claim Discrepancy 3

Not a Reminder 2

Lots of claim interpretation objections for DTC

                                                        

March 31, 2003

Ads Boost Consumer AwarenessOf Drugs, but Downplay Risks.

Drug makers spent almost $3 billion on consumer ads last year, about a 7% increase over 2001. And consumers generally like them, notwithstanding some suspicions that the ads inflate drug costs, surveys show. But doctors, regulators and consumer advocates continue to have concerns.A survey of 500 doctors conducted by the FDA last year and presented at the conference asked whether consumer drug ads confused patients about the relative risks and benefits of medicines. Some 70% of general practitioners and 60% of specialists answered "somewhat" or "a great deal." Only 5% of general practitioners and 10% of specialist said "not at all."

                                                              April 15, 2002

    

 

ADVERTISING

    

 

Patients' Success in Drug RequestsShows the Power of Medication Ads

DTC

Beneficial Effects – MD Survey

YES41%

NO59%

N = 459

Did the fact that this patient saw an advertisement have any beneficial effects for your interaction with this patient?

Aiken, 2003

What beneficial effects did it have?

53%

42%

10%

10%

9%

6%

2%

3%

0 10 20 30 40 50 60

Some other reason

Patient sought treatment for serious condition

New condition was discovered

Patient more likely to consider using Rx drug

Patient more likely to take prescribed drug

Informs/educates

Patient more aware of treatments

Better discussion with patient

N = 187

Percent

Aiken, 2003

ProblemsYES18%

NO82%

N = 459

Did the fact that this patient saw an advertisement create any problems for your interaction with this patient?

Aiken, 2003

What problems did it cause?

26%

41%

9%

5%

5%

4%

4%

2%

2%

9%

0 10 20 30 40 50

Some other reason

Unrealistic expectations

Concerns-SE's

Concerns-insurance

Should listen to Dr rather than ad

Pressure to prescribe

More visit time

Wanted Rx rather than other treatment

Drug not needed/did not have condition

Time correcting misconceptions

N = 187Percent

Aiken, 2003

Current Views of DTCSurveys show few Benefits, few Problems

Risk Communication – balance a key issueSuggestion to pay into consumer education “pot”

DTC remains heavily regulatedImplied Claims often focus of objectionFDA regulation is mitigated by GC review

Doctors still skepticalStill despised by MCOs and payersRisk Management Issue

Forteo (Lilly), no DTC