Regulatory History of Regulatory History of Pediatric Cough/Cold Pediatric Cough/Cold Products Products Joint Meeting of the Nonprescription Drugs Joint Meeting of the Nonprescription Drugs Advisory Committee (NDAC) and the Pediatric Advisory Committee (NDAC) and the Pediatric Advisory Committee (PAC) Advisory Committee (PAC) Silver Spring, Maryland Silver Spring, Maryland October 18 & 19, 2007 October 18 & 19, 2007 Marina Y. Chang, R. Ph. Team Leader, Interdisciplinary Scientist Division of Nonprescription Regulation Development Office of Nonprescription Products Center for Drug Evaluation and Research Center for Drug Evaluation and Research
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Regulatory History of Pediatric Cough/Cold Products Joint Meeting of the Nonprescription Drugs Advisory Committee (NDAC) and the Pediatric Advisory Committee.
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Regulatory History ofRegulatory History ofPediatric Cough/Cold Products Pediatric Cough/Cold Products Regulatory History ofRegulatory History ofPediatric Cough/Cold Products Pediatric Cough/Cold Products
Joint Meeting of the Nonprescription Drugs Advisory Joint Meeting of the Nonprescription Drugs Advisory Committee (NDAC) and the Pediatric Advisory Committee (NDAC) and the Pediatric Advisory Committee (PAC)Committee (PAC)Silver Spring, MarylandSilver Spring, Maryland
October 18 & 19, 2007October 18 & 19, 2007
Marina Y. Chang, R. Ph.Team Leader, Interdisciplinary ScientistDivision of Nonprescription Regulation DevelopmentOffice of Nonprescription Products
Joint Meeting of the Nonprescription Drugs Advisory Joint Meeting of the Nonprescription Drugs Advisory Committee (NDAC) and the Pediatric Advisory Committee (NDAC) and the Pediatric Advisory Committee (PAC)Committee (PAC)Silver Spring, MarylandSilver Spring, Maryland
October 18 & 19, 2007October 18 & 19, 2007
Marina Y. Chang, R. Ph.Team Leader, Interdisciplinary ScientistDivision of Nonprescription Regulation DevelopmentOffice of Nonprescription Products
Center for Drug Evaluation and ResearchCenter for Drug Evaluation and Research
What is Professional Labeling What is Professional Labeling for an OTC Ingredient?for an OTC Ingredient?
What is Professional Labeling What is Professional Labeling for an OTC Ingredient?for an OTC Ingredient?
• Information for healthcare providers for conditions that consumers can not self-diagnose or safely treat– Aspirin to treat rheumatoid arthritis– Antihistamine for children < 6 years
• Not on the “Drug Facts” label
• Information for healthcare providers for conditions that consumers can not self-diagnose or safely treat– Aspirin to treat rheumatoid arthritis– Antihistamine for children < 6 years
What did the Cough/Cold Advisory Review What did the Cough/Cold Advisory Review Panel think about the Dosing for Children? Panel think about the Dosing for Children?
(1972) (1972)
What did the Cough/Cold Advisory Review What did the Cough/Cold Advisory Review Panel think about the Dosing for Children? Panel think about the Dosing for Children?
(1972) (1972)
• Traditionally, dosing for infants and children has been based on weight, body surface area or age of the child as a proportion of the “usual adult dose”
• However the panel noted:– Data on use in children for most drugs is negligible or
nonexistent– Dosing in a particular individual dependent on many factors
– Definitive data should be derived from clinical trials with
children, but these are extremely difficult to conduct
– Need to make recommendation for pediatric dosage
pending data
• Traditionally, dosing for infants and children has been based on weight, body surface area or age of the child as a proportion of the “usual adult dose”
• However the panel noted:– Data on use in children for most drugs is negligible or
nonexistent– Dosing in a particular individual dependent on many factors
– Definitive data should be derived from clinical trials with
children, but these are extremely difficult to conduct
– Need to make recommendation for pediatric dosage
What did the Cough/Cold Advisory Review What did the Cough/Cold Advisory Review Panel recommend about Dosing for Panel recommend about Dosing for
Children?Children? (1972) (1972)
What did the Cough/Cold Advisory Review What did the Cough/Cold Advisory Review Panel recommend about Dosing for Panel recommend about Dosing for
Children?Children? (1972) (1972)
• Dosing calculated based on age is – Most convenient and easily understood – May be least reliable (weight variation) – History of wide margin of safety
• From adverse events reported• Time and extent of use
• Dosing calculated based on age is – Most convenient and easily understood – May be least reliable (weight variation) – History of wide margin of safety
• From adverse events reported• Time and extent of use
Federal Register PublicationFederal Register Publication (1988) (1988) (cont.)(cont.)
Federal Register PublicationFederal Register Publication (1988) (1988) (cont.)(cont.)
• Solicit comments on how pediatric dosing information should be presented in labeling: – Age and weight-based dosing schedule– Greater subdivisions of age ranges – Another approach?
• Solicit comments on how pediatric dosing information should be presented in labeling: – Age and weight-based dosing schedule– Greater subdivisions of age ranges – Another approach?
NDAC Meeting on Pediatric NDAC Meeting on Pediatric Dosing and Labeling (1995)Dosing and Labeling (1995)NDAC Meeting on Pediatric NDAC Meeting on Pediatric Dosing and Labeling (1995)Dosing and Labeling (1995)
• Provide advice on pediatric dosing and labeling– Age, weight, height or length, body surface area or
combination
Answer: Weight, then age • Is the current dosing approach adequate?
Answer: 2-dose division is not adequate, but multi-dose divisions cannot be used for all products
• Provide advice on pediatric dosing and labeling– Age, weight, height or length, body surface area or
combination
Answer: Weight, then age • Is the current dosing approach adequate?
Answer: 2-dose division is not adequate, but multi-dose divisions cannot be used for all products
• Temporarily relieves runny nose, sneezing, itching of the nose or throat and itchy, watery eyes due to hay fever or other upper respiratory allergies.
• Temporarily relieves runny nose and sneezing associated with the common cold. (currently allowed under the TFM)
• Temporarily relieves runny nose, sneezing, itching of the nose or throat and itchy, watery eyes due to hay fever or other upper respiratory allergies.
• Temporarily relieves runny nose and sneezing associated with the common cold. (currently allowed under the TFM)