# Presentation: 236749

## Consumer-Directed Promotion Public MeetingDocket No. 2003N-0344

- Linda F. Golodner, President
- National Consumers League
- September 22, 2003

## National Consumers League

- Founded 1899, representing consumer in marketplace and workplace issues
- Research, education and advocacy
- Bringing together government, consumer, health professional, industry
- Healthcare major program of NCL
- Direct-to-Consumer Advertising and Promotion surveys and forums

## NCL Stakeholders Meetings on DTC

- 1996 and 1998 to address issues surrounding DTC
- Presented surveys and research data
- Purpose:  to create consensus document to serve as recommendations to the FDA on how to revise and improve DTC promotion

## October, 2002 Survey Data

- Commissioned OTC International
- National Random Sample Survey:  1,012 adults, 18 years and older plus an additional 160 adults 65 and older
- Purpose:  to examine the effectiveness of medical advertising to adults, particularly among seniors

## What in the Advertising Interested Them

- Those who saw advertising
- They or family member has condition
- Learn more about medication
- New
- Interest in the condition
- Concern about the risk

## Slide 6

## Presence of condition

## Slide 8

## Taking Action After Seeing Ad

- More than half of adults who were interested, took some action
- 31% decided to talk with doctor at next appointment
- 26% sought more information
- 16% contacted doctor immediately

## Slide 10

## Seeing More Information

- 16% turned to pharmacist
- 14% looked to a medical or drug reference book
- 14% visited general information on Internet
- One in 10 talked to a nurse or called an 800 number

## Slide 12

## After Seeking More Information

- 64% contacted doctor by visiting or calling
- 14% decided medication was not for them or another member of the family
- 11% decided that they or a family member did not have the condition the medication was treating

## Visiting the Doctor

- Of those who talked to or visited their doctor after seeing an ad about medication that interested them **(this is 5% of all adults), **half said they wanted to find out if the medication was right for them, while one in three said they wanted to find the best way to treat their condition.  One in ten wanted to get the drug that was advertised.

## Slide 15

## Slide 16

## Visiting the Doctor

- Of those who talked to or visited doctor, of those who said doctor prescribed med, 71% say it helped condition; one in ten said it didn’t help.

## Attitudes Toward Advertising

- What is your feeling about advertisements about prescription medications? (1-5 Scale)

## Slide 19

## Conclusions

- Consumers use the advertisements to learn more about drugs/conditions that are of interest to them.
- Patients talk to their doctors about the drugs/conditions
- Consumers recognize that this is advertising and that pharmaceutical companies want to sell the drugs

## Recommendations of Stakeholder Meetings Still Appropriate

- #1  The old 21 C.F. R. 202.1 must be amended to provide address direct-to-**consumer** advertising and should incorporate lay consumer comprehension into its evaluative criteria

## Recommendations

- #2 The “brief summary” should be reformatted to provide important risk and benefit information in consistent, balance, useful format in plain language.
- Should not be required to include exhaustive risk information from full product label – emphasis should be on most serious and most frequent side effects and ADEs – MedGuide format
- The “adequate provision” requirements of Broadcast Guidance could be adapted to the print format

## Recommendations

- #3  Standardized information panels have been very effective for other FDA-regulated products – Nutrition Facts, Supplements Facts, Drug Facts (OTC)
- A similar, consistent “Drug Facts” panel format could be adopted for use in DTC promotions of prescription drugs

## Recommendations

- #4  Advertisers must be more cognizant that consumers are not necessarily “taking away” important health information.  In many cases, consumers cannot identify the disease for which drug is indicated.  Some consumers do not recall most serious and most common risks.  Pharmaceutical companies should improve ads so there is better comprehension and retention of this important information.

## Finally....

- DTC promotion should not be false or misleading
- It should be fairly balanced
- It should help consumers seek additional information
- It is a useful tool for patient/health professional communication

## Contact information

- <date/time>

- Linda F. Golodner, President
- National Consumers League
- 202-835-3323
- _[Lindag@nclnet.org](mailto:Lindag@nclnet.org)_
- www.nclnet.org