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Charge to the Committee

Charge to the Committee. Linda M. Katz, M.D., M.P.H. Deputy Director Division of Over-the-Counter Drug Products June 21, 2002. Prilosec Rx (20 mg capsule). Approved indications Treatment of gastric and duodenal ulcer Symptomatic GERD Erosive eosphagitis

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Charge to the Committee

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  1. Charge to the Committee Linda M. Katz, M.D., M.P.H. Deputy Director Division of Over-the-Counter Drug Products June 21, 2002

  2. Prilosec Rx (20 mg capsule) • Approved indications • Treatment of gastric and duodenal ulcer • Symptomatic GERD • Erosive eosphagitis • Pathologic hypersecretory conditions

  3. Antacids & H2 Receptor Antagonists Relief of heartburn (antacids only) Prevention of heartburn Prilosec 1 Prevention of frequent heartburn (>2 episodes per week) Indications for OTC Use

  4. Issues for Decision-Making Process • Benefit-risk • Consumer ability to self-diagnose and self-treat • Consumers ability to understand labeling instructions including monitoring, follow-up care and treatment • Ability to recognize attainment of goal • Ability to recognize toxicity

  5. Rx Drug Patient Disease/condition requiring monitoring Health care practitioner Prescription required OTC Drug Consumer Symptom relief No prescription Rx versus OTC Drug

  6. Actual Use and Label Comprehension Issues • Ability to appropriately self-select • Ability to use the correct dosage, for the time specified in the label • Ability to identify when to see a physician • Ability to identify serious adverse events • Ability to avoid interacting drugs

  7. Issues for Discussion • Has the sponsor identified an appropriate target population? • Consider: • Symptomatic overlap with GERD • <2 episodes of heartburn a week • Relative contraindications • Recurrence of symptoms (after discontinuation) • Chronicity of therapy (i.e., repeat dosing) • Management of acute symptoms

  8. Issues for Discussion (continued) • Has the sponsor demonstrated that consumers can adequately self-select to use? • Did consumers with recurrence understand how to use the product? • Has the sponsor proposed an acceptable duration of therapy for OTC use?

  9. Issues for Discussion (continued) • Short-term versus chronic intermittent use • Concerns about delayed diagnosis of a serious condition • Concerns about rebound after discontinuing treatment

  10. OTC Marketing • Has the sponsor provided sufficient information to support the approval of OTC Prilosec 1 for the treatment of frequent heartburn?

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