1. Summary of Issues on Urticaria as an OTC Indication Charles Ganley, M.D. Division of OTC Drug Products April 22, 2002 Non-Prescription Drug Advisory Committee

2. April 22, 20022 Safety Criteria for OTC Drugs Low incidence of adverse reactions or significant side effects under adequate directions for use Warnings against unsafe use Low potential for harm which may result from abuse under conditions of widespread availability

3. April 22, 20023 Observations FDA position on urticaria as an OTC indication Urticaria or hives is an OTC indication in other countries –recognize that pharmaceutical marketing, consumer behavior, pharmacy practices vary Consumers may be already using OTC anti- histamines for urticaria –influenced by information resources, marketing (Brand names that include “Allergy”)

4. April 22, 20024 Urticaria (hives) as an OTC Use For acute or chronic hives –Frequency and significance of Associated conditions (e.g. angioedema, anaphylaxis) Consequences leading to serious adverse outcomes Conditions misdiagnosed by the consumer as urticaria (e.g. vasculitis, manifestation of another disease)

5. April 22, 20025 Urticaria (hives) as an OTC Use Physician intervention –When is it necessary –Delay in seeking physician advice Consumer behavior –Does OTC availability encourage self-treatment without diagnosis for chronic urticaria –Can consumers self-diagnose –What will influence behavior

6. April 22, 20026 Sponsor Proposal for an OTC Urticaria Indication The use should be limited to consumers who have a diagnosis of chronic idiopathic urticaria (CIU) by a physician Accuracy of self-selection and use of the product by a CIU population –Surveys –Label Comprehension

7. April 22, 20027 Other “Studies”: Consumer and Physician Surveys Source: Internet database –Unable to validate the background of responders Physician survey provides anecdotal experience Consumer survey of CIU sufferers –Multiple choice questions were used instead of open ended questions –Oral anti-histamines used by 62% prior to physician diagnosis –Chronic idiopathic urticaria not commonly used term

8. April 22, 20028 Sponsor Proposal: Limit to CIU Population Limitation of use to CIU population accomplished through labeling –“use only after being told by a doctor that you have recurring or chronic hives of an unknown source (chronic idiopathic urticaria)”

9. April 22, 20029 Prior Experience with Restriction to Physician Diagnosed Population Vaginal Anti-fungal products Do not use if you have never had a vaginal yeast infection diagnosed by a doctor Restriction is not adhered to by many consumers –Internal NDA data from an actual use study 40% did not have a prior diagnosis by a physician –20% - 34% in published reports did not have previous diagnosis

10. April 22, 200210 Problems with this Approach Product likely to be used for any type of urticaria –20 - 25 % of subjects who experience hives have chronic hives No data provided to demonstrate accurate self- selection and de-selection in a general population No consensus for consumers on the name CIU “Hives” likely to translated broadly by consumer The labeling restriction proposed by the sponsor will not likely limit use to CIU subjects

11. April 22, 200211 Issues for the Committee Urticaria as an OTC claim –If no, what is the basis for denying? (If no, there is no need to continue the meeting) Sponsor data to support chronic urticaria as a claim –Chronic vs. general claim for hives –Type of information to support efficacy and safety OTC –Labeling issues