# Presentation: 752391

## Direct-to-consumer advertising of prescription medicines in the United States and New Zealand:

- Food and Drug AdministrationPublic Hearing on Direct-to-Consumer Promotion of Medical ProductsNovember 2, 2005

## Background1

- New Zealand and the US are the only advanced nations that permit DTCA of prescription medicines.
- Because it was not prohibited, DTCA emerged in these two distant and distinct economies.
- United States
- Immense economy
- Predominantly privately-funded healthcare
- Unregulated drug prices
- Stringent regulation of DTCA by same agency that approves medicine
- 1Calfee J, Hoek, J. & Gendall, P. (2004) *Journal of International Advertising*, **23**(2), pp. 197-227.

## New Zealand
Small economy
Predominantly government-funded healthcare
Regulated drug prices
Advertising self-regulation combined with loose oversight by the Ministry of Health
How do consumers perceive and use DTCA in these strongly contrasting circumstances?
What can we learn from the New Zealand experience?

- Small economy
- Predominantly government-funded healthcare
- Regulated drug prices
- Advertising self-regulation combined with loose oversight by the Ministry of Health
- How do consumers perceive and use DTCA in these strongly contrasting circumstances?
- What can we learn from the New Zealand experience?

- Background

## Principles of DTCA Regulation

| New Zealand requirements |
| --- |
| Should comply with the laws of New Zealand and relevant Industry Code of Ethics |
| Meets 'high standard of social responsibility' by including the following statements: |
| 'Use strictly as directed' |
| 'If symptoms continue or you have side-effects, see your doctor/pharmacist/health professional' |
| 'Prescription medicine, consult your doctor' |

## Principles of DTCA Regulation

| New Zealand requirements |
| --- |
| If there is a charge for a prescription medicine in excess of the standard prescription fee, this should be indicated |
| Must not deceive or mislead, abuse trust, exploit lack of knowledge or play on fear |
| Clear communication of scientific information in a way the relevant audience will understand |
| Must not promote inappropriate consumption |
| May not imply endorsement without appropriate consent |

## Principles of DTCA Regulation

| US requirements |
| --- |
| Include a 'fair balance' of risk and benefit information |
| Include a 'major statement' of the drug’s major risks |
| Make 'adequate provision' for dissemination of further details provided in package labelling  |
| Must not be false or misleading in any respect |
| Provide information in 'consumer-friendly' language |

## Exposure to DTCA by Medium

|  |  |  |  |  |
| --- | --- | --- | --- | --- |
|  | Percentage awareness |  |  |  |
| Medium | NZ study1 
(n = 616) |  | FDA 19992 
(n = 688) | FDA 20022 
(n = 762) |
| Television | 98 | 94 |  | 97 |
| Magazine | 60 | 66 |  | 75 |
| Newspaper | 41 | 29 |  | 32 |
| Radio | 37 | 28 |  | 31 |
| Direct mail | 15 | 17 |  | 22 |
| Billboards | 9 |  |  |  |
| Internet | 9 | 9 |  | 16 |
|  |  |  |  |  |
|  |  |  |  |  |

- 1 The New Zealand study conducted and reported by Hoek and Gendall (2003).

- 2 The US Food and Drug Administration survey results 1999 & 2002.

## Information Recalled From Television and Print Advertisements

|  |  |  | FDA 1999
Television
(n = 688) | FDA 2002
television
(n = 737) |
| --- | --- | --- | --- | --- |
|  | NZ study1
(n = 516) | NZ study1
(n = 401) |  |  |
| Information |  |  |  |  |
| Benefits of the medicine | 82 | 82 | 87 | 90 |
| Details of who should take the medicine | 61 | 54 | 76 | 74 |
| Questions to ask a doctor | 49 | 36 | 63 | 71 |
| Directions for use | 36 | 33 | 34 | 35 |
| Details of who should not take 
the medicine | 29 | 28 | 81 | 89 |
| Risks or side-effects of the 
medicine | 20 | 27 | 82 | 90 |

**Percentage recall**

- 1Calfee J, Hoek, J. & Gendall, P. (2004) *Journal of International Advertising*, **23**(2), pp. 197-227.

## US and New Zealand Consumers’ Attitudes to DTCA

- 59

- -

- 37

- Confuse people about which medicine is right for them and the benefits of Rx medicines

- 64

- 46

- 52

- Help people make better decisions about their health and prescription medicines

- -

- 61

- I find prescription medicine advertising helpful

- 81

- 86

- 91

- Help make people aware of new medicines

**DTCA and consumers**
*Advertisements for prescription medicines...*

*Prevention**1** 02*
- (*n* = 1601)

- FDA 1999
- (*n* = 1081)

- NZ
- (*n* = 632)

**Agreement with Statements (%)**

**Statement**

- -

- 1Slaughter, E. (2001-2002) 5th Annual Survey, Consumer reaction to DTC advertising of prescription medicines: DTC advertising and self-care, honoring requests for prescription medicines. *Prevention Magazine *Report.

## US and New Zealand Consumers’ Attitudes to DTCA

- 48

- 29

- 15

- Only the safest prescription medicines are advertised/Government regulation allows only the safest Rx medicines to be advertised

*I think...*

**DTCA and consumers**

*Prevention 02*
- (*n* = 1601)

- FDA 1999
- (*n* = 1081)

- NZ
- (*n* = 632)

**Agreement with Statements (%)**

**Statement**

## US and New Zealand Consumers’ Attitudes to DTCA

|  | Agreement with Statements (%) |  |  |
| --- | --- | --- | --- |
|  | NZ
(n = 632) | FDA 1999
(n = 1081) | Prevention
2002
(n = 1601) |
| Balance of Information
Advertisements for prescription medicines... |  |  |  |
|  |  |  |  |
|  |  |  |  |
| Should give more information about the risks or side-effects/Make medicines seem harmless | 78 | 59 | 49 |
| Should give more information about the benefits of using the medicine/Do not give enough benefit information | 50 |  | - |
| Make the medicines seem better than they really are/Are more likely [than other forms of advertisements] to exaggerate the benefits of using the product | 44 | 58 | 69 |
| I trust the information in prescription medicine advertisements | 29 | - | - |

- 33

**Statement**

## US and New Zealand Consumers’ Attitudes to DTCA

- -

- 24

- Help people to have better discussions with their doctor about their health
- Make it seem as though a doctor is not needed to decide whether a medicine is suitable/Cause tension between patients and their doctors

- Give people enough information to decide whether they should discuss the medicine with their doctor

**DTCA and doctors’ role**
*Advertisements for prescription medicines...*

*Prevention*
- 2002
- (*n* = 1601)

- FDA 1999
- (*n* = 1081)

- NZ
- (*n* = 632)

- 61

- -

- 64

- 37

- 41

**Statement**

**Agreement with Statements (%)**

- 67

- 68

- -

## Conclusions

-  N.Z. and the U.S. present very different regulatory systems and pharmaceutical markets
- DTC ads in N.Z. and the U.S. also tend to be quite different (far less warning information in N.Z. ads, although the N.Z. regulations are changing)
- Consumer surveys in both nations reveal remarkably consistent results on many essential points
- The surveys document substantial and similar benefits from DTC ads in both nations
- In both nations, surveys reveal little evidence of harm from DTC advertising

## References

-  Hoek, J., Gendall, P., Calfee, J. (2004) Direct-to-consumer advertising of prescription medicines in the United States and New Zealand: an analysis of regulatory approaches and consumer responses. *Internation Journal of Advertising*, **23**(2).
-  Hoek, J. & Gendall, P. (2002a) Direct to consumer advertising of prescription medicines: self-regulation or legislation? Journal of Marketing Communications, **8**(2), pp. 71-85.
- Food and Drug Administration (FDA) Center for Drug Evaluation and Research, Division of Drug Marketing, Advertising, and Communications (1999) Attitudes and Behaviors Associated with Direct-to-Consumer (DTC) Promotion of Prescription Drugs: Main Survey Results (accessed April 10, 2002),.
- Food and Drug Administration (FDA) Center for Drug Evaluation and Research, Division of Drug Marketing, Advertising, and Communications (2002c) “DTC Advertising,” presentation of results from the 2002 consumer survey on attitudes toward direct-to-consumer promotion of prescription drugs (accessed April 10, 2002).
- Slaughter, E. (2001-2002) 5th Annual Survey, Consumer reaction to DTC advertising of prescription medicines: DTC advertising and self-care,  honoring requests for prescription medicines. *Prevention Magazine *Report.
- Hoek, J. & Gendall, P. (2003) Direct to consumer advertising of prescription medicines: a consumer survey. Department of Marketing Research Report, April 2003.