Robert J. Spiegel, M.D. Sr. V. P. Medical Affairs Chief Medical Officer Schering Plough

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• published: 21 Jun 2016
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Don't hesitate to comment below if you have any questions or additional phrases FDA ADVISORY COMMITTEE 5/11/01 Robert J. Spiegel, M.D. Sr. V. P. Medical Affairs Chief Medical Officer Schering Plough ,OVERVIEW For many patients, allergies are not appropriately treated without physician management More data are necessary to support this OTC switch based on unique issues of use OTC status will decrease access for many patients, and may not decrease use of first-generation anti-histamines ,OVERVIEW For many patients, allergies are not appropriately treated without physician management Different types of antihistamine users Short-term vs. chronic Comorbid diseases Cold Use vs. Allergy Disease Management ,OVERVIEW For many patients, allergies are not appropriately treated without physician management More data are necessary to support this OTC switch based on unique issues of use OTC status will decrease access for many patients, and may not decrease use of first-generation antihistamines , “Data to support the OTC switch generally comes from the following sources: efficacy trials, safety data, actual use trials, and label comprehension trials…these latter two trials may or may not be needed depending upon whether there are any unique issues related to use, warnings, or directions that need to be tested prior to marketing.” “The switch of a prescription drug to OTC marketing requires a review of the post-marketing safety data and a determination that a consumer can adequately use the product in an OTC setting” FDA OTC Antihistamine Review Team 4/5/01 ,OVERVIEW For many patients, allergies are not appropriately treated without physician management More data are necessary to support this OTC switch based on unique issues of use OTC status will decrease access for many patients, and may not decrease use of first-generation antihistamines ,For many patients, allergies are not appropriately treated without Physician Management 1. Prescription status may be necessary to protect and optimize public health ,U.S. Health Care System - 2001 - Evidence-based medicine - Guideline-driven practice - Disease management approach ,U.S. Health Care SystemAllergy Management - 2001 Diagnostic Evaluation Differentiate allergic disorders from other diseases Uncover previously unsuspected allergens Assess comorbid conditions Environmental Assessment– Antigen Testing Pharmacologic Therapy Antihistamines +Rx for Comorbid Conditions Decongestants Nasal Steroids Immunotherapy Follow-up, Reassessment, Compliance Management ,For many patients allergies are not appropriately treated without Physician Management 1.Prescription status may be necessary to protect and optimize public health 2.The safety profiles of the second-generation antihistamines in an OTC setting are not fully known ,2. The safety profiles of the second- generation antihistamines in an OTC setting are not fully known How often will they be used to treat colds? How often will patients dose incorrectly? How many patients will experience exacerbation of untreated or unrecognized co-morbidities? How often will patients have adverse outcomes as a result of delays in seeking medical care? ,For many patients allergies are not appropriately treated without Physician Management 1.Prescription status may be necessary to protect and optimize public health 2.The safety profiles of the second-generation antihistamines in an OTC setting are not fully known 3.Allergies are frequently chronic, complex diseases with serious co-morbidities ,Allergies are frequently chronic, complex diseases with Serious Comorbidities Co-morbid conditions associated with allergic rhinitis Asthma Sinusitis Otitis Media Children are seriously affected by allergic rhinitis 10-40% of school children Under treatment is related to learning and behavioral problems ,Allergies: >50 million Americans Asthma: 15 million Americans 4.8 million children Asthma Prevalence