Post on 04-Jan-2016
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DTC Policy “Change”Draft Guidance - July, 1997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