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Questions for the Public Hearing for Over-the-Counter Cough and Cold Medications
FDA is interested in obtaining public comment on the following issues relating to the use of pediatric cough and cold medicines:
1. What types of studies, if any, should be conducted to assess effectiveness and/or safety, and determine appropriate dosing of cough and cold ingredients in the pediatric population? How should these studies be designed and powered?
2. Should cough and cold products for the pediatric population continue to be available OTC, or should they be made available only by prescription?
3. If the pediatric indications and dosing for cough and cold products were no longer available OTC, would the public use the adult formulations of the OTC monograph products for children, and thus create a greater risk of misuse or overdose?
4. Do the answers to the previous questions depend on the age of the pediatric patients? If so, how should age be considered in making regulatory decisions for these products?
5. At the time the monograph was established, FDA routinely extrapolated safety and efficacy data from adults to children age 12 and over. Current PREA standards permit extrapolation of pediatric efficacy -- but not safety-- based upon sufficient adult data. Does it remain appropriate to recommend in the cough and cold monograph that children 12 and over should receive the same dose of medication as adults, without requiring any additional studies in children in this age group? What additional safety and/or efficacy studies should be required in this age group?
6. What is the most appropriate method for determining pediatric doses that could be used as an alternative to the quarter- and half-dose assumptions used in the monograph? Should products be dosed by age, by weight, or both?
7. There are monographs for topical and intranasal ingredients to treat the common cold. Should these monographs be considered in a similar fashion to the oral cough and cold products? Are the answers to the previous questions different for any subcategories of cough and cold medicines (e.g., topical or intranasal products)?
8. The CCABADP monograph allows for the combination of ingredients to treat colds and/or coughs. Should combination products be permitted for all pediatric age groups? Should data be provided to support each unique combination?
9. Can measurement errors in dosing be reduced using more standardized measuring devices or alternative dosage forms and, if so, what is the best way to effect this change?
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Date created: August 22, 2006
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