1. Prilosec Label Comprehension Study Karen Lechter, J.D., Ph.D. Division of Drug Marketing, Advertising, and Communications

2. Purpose of Label Comprehension Studies 21 CFR 330.10(a)(4)(v) [OTC labels shall be written] in such terms as to render them likely to be read and understood by the ordinary individual, including individuals of low comprehension, under customary conditions of purchase and use.

3. MainStudyCharacteristics • Mall intercept • N=504 • Male and female >age 18

4. MainStudyCharacteristics 4 cohorts: 1. heartburn sufferers (N=197) 2. heartburn non-sufferers (N=104) 3. low literate (<8th grade reading) [N (sufferers) =101; N (non-sufferers) =54)] 4. must ask doctor before use (N=117) --take certain meds., pregnant, nursing

5. Product Purpose When asked purpose of product: • 99% prevention or relief or both • 65% relief • 18% prevention • 16% prevention and relief Label says prevention and relief

6. Do Consumers Understand? • What to do after 14 days of use (83%) • What to do if trouble swallowing (81%) • When take to prevent if expect stress (80%) • When take to prevent if expect meal (83%) • Low literate (75%) • If can take 2 within 24 hours (2 Q’s) (81%, 83%) • Low literate (74%, 81%)

7. Troubling Result • 74% of cohort 4 (should see doctor before use) incorrectly said they would use the product to prevent and relieve (2Q’s) • 21% correct--would not use

8. Addendum Study • Does wording of question about self-use in cohort 4 contribute to incorrect responses? • Compared responses to original self-use question with new self-use question • N=58 (29 in each arm) • All should ask doctor before use: • pregnant, nursing, taking certain drugs

9. Addendum Study Questions Original questions: If you wanted to prevent/relieve heartburn, would you use Prilosec 1 yourself? New questions: If you were a heartburn sufferer and you wanted to prevent/relieve heartburn, would it be okay for you (,personally,) to use Prilosec 1 yourself, or not?

10. Addendum Study Results % correct preventionrelief Original Question 35% 31% Reworded Question 69% 59% Even with the reworded question, comprehension is low

11. Additional Addendum Study Questions If prior response is incorrect: • Is there anything you would do prior to taking this product, or not? If prior response is incorrect: • Considering your current health and medications you are currently taking, would it be necessary for you to contact a doctor prior to using this product yourself, or not?

12. Additional Addendum Study Questions If prior response is incorrect: • Are you currently taking any of the following medications? diazepam, warfarin, phenytoin If prior response is incorrect: • Are you currently taking any of the following medications? Valium, Coumadin, Dilantin Results of leading questions have uncertain value

13. Addendum Study Conclusions • Group that should consult with physician before use demonstrates problems in both studies • 59%-69% correct responses to new question

14. Tested Label vs. NDA Label • Label changed substantially after label comprehension test • New label not tested

15. Tested Label vs. NDA Label NDA label added • Causes of symptoms for prevention • Allergy warning • “Do not use” section • Do not use with acid reducers • New drugs to ask about • Wording about taking for prevention • Amount of water to drink

16. Tested Label vs. NDA Label NDA label • Specified # days after which see doctor • Changed 14 day limit to 10 days • Ask pharmacist as well as doctor about drugs • Changed wording: trouble swallowing, pregnancy, directions, storage instructions • Reversed--relief and prevention indications and directions • Bolded and added warning symbol to instruction not to take more than 10 days

17. NDA Label NDA Label was not tested

18. Summary • Consumers associate product with relief • 65% said it is for relief • Data suggest potential for substantial use by persons who should consult doctor first • Some information is not strongly communicated • Most recent label not tested • Differs significantly from tested label