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NDAC/ PADAC Joint Meeting

NDAC/ PADAC Joint Meeting. May 11, 2001 Cazemiro R. Martin Regulatory Review Chemist FDA, Division of OTC Drug Products. Prescription Availability. Durham-Humphrey Amendment to the Federal FD&C Act (1951). Durham-Humphrey Amendment.

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NDAC/ PADAC Joint Meeting

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  1. NDAC/PADACJoint Meeting May 11, 2001 Cazemiro R. Martin Regulatory Review Chemist FDA, Division of OTC Drug Products

  2. Prescription Availability Durham-Humphrey Amendment to the Federal FD&C Act (1951)

  3. Durham-Humphrey Amendment 503(b)(1)(A) : Because of toxicity or potentially harmful effects (not safe unless used under supervision) or…. 503(b)(1)(B) : Limited by approved application to use under supervision

  4. OTC Availability • New Drug Application Process (NDA) • Prescription (Rx)-to-OTC Switch process • Marketed directly OTC • OTC Drug Monograph Process • Established conditions under which OTC drug products are generally recognized as safe and effective (GRAS/E)

  5. NDA ProcessRx-to-OTC Considerations: • Can the condition be adequately self-recognized? • Can the condition be successfully self-treated? • Is the self-treatment product safe and effective during consumer use?

  6. NDA ProcessRx-to-OTC Switch Candidate: • Acceptable margin of safety based on prior prescription marketing experience • OTC dosages/indications are relatively safe - low misuse potential - minimal abuse potential - reasonable therapeutic window of safety

  7. NDA ProcessRx-to-OTC Switch Candidate (cont.) • Self-treatment and self-monitoring with minimal physician supervision • Adequately labeled to allow safe and effective use of the OTC drug • Benefits from the OTC switch clearly outweigh the risks

  8. OTC Drug Monograph Process • Advisory Review Panel • Advance Notice of Proposed Rulemaking - advisory panel report • Tentative Final Monograph • Final Monograph

  9. Advisory Review Panel OTC Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products

  10. Advanced Notice of Proposed Rulemaking - 1976 Panel’sAntihistamine Review • Effective in suppressing symptoms of allergic rhinitis (such as hay fever) • Low order of acute and chronic toxicity

  11. Advisory Panel Report (Antihistamine Review-cont.) • Common side effects - rarely serious • CNS depression: drowsiness • Anticholinergic: dryness of the mouth; urinary retention; reduced bronchial secretions • Rarely occurring side effects • Cardiovascular, gastrointestinal, hematological

  12. Advisory Panel Report (Antihistamine Review-cont.) • Labeling recommendations: Uses: temporary relief of symptoms associated with allergic rhinitis Warnings: • may cause drowsiness • avoid driving or operating machinery • avoid alcoholic drinks • consult a physician before use if you have difficulty in urination or difficulty breathing

  13. Tentative Final Monograph January 15, 1985

  14. Final Monograph - 1992(OTC Antihistamines) 21 CFR 341 • 13 antihistamine active ingredients marketed under the OTC drug monograph system • Final rule addresses “allergy” indications only • Labeling of OTC antihistamine drug products

  15. Brompheniramine maleate Chlorcyclizine HCl Chlorpheniramine maleate Dexbrompheniramine maleate Dexchlorpheniramine maleate Diphenhydramine citrate Diphenhydramine HCl Doxylamine succinate Phenindamine tartrate Pheniramine maleate Pyrilamine maleate Thonzylamine HCl Triprolidine HCl OTC Monograph Antihistamines21 CFR 341.12

  16. OTC NDA/ANDA Antihistamines Extended Release: Brompheniramine maleate  Chlorpheniramine maleate  Dexbrompheniramine maleate  Triprolidine HCl Immediate Release:  Clemastine fumarate

  17. Methapyrilenefumarate MethapyrileneHCl Phenyltoloxamine dihydrogen citrate PromethazineHCl ThenyldiamineHCl Tripelennamine HCl - potential carcinogen - potential carcinogen - inadequate efficacy data - tardive dyskinesia: causal role - single ingredient: no long-term use - inadequate efficacy data - safe/effective:no data submitted Nonmonograph Ingredients

  18. OTC Antihistamines Drug Facts Labeling 21 CFR 201.66 Format and Content Requirements for OTC Drug Product Labeling

  19. Summary • OTC Drug Products: • acceptable margin of safety (minimal toxicity) • low potential for harmful effects • low misuse/minimal abuse potential • reasonable therapeutic window of safety • Self-treatment and self-monitoring • Adequately labeled to allow safe and effective use • Benefits outweigh risks

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