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The US Food and Drug Administration will hold a public hearing Oct. 2, 2008, to obtain input regarding over-the-counter (OTC) cough and cold drugs marketed for pediatric use.
Rockville, MD (Aug. 28)-The US Food and Drug Administration will hold a public hearing Oct. 2, 2008, to obtain input regarding over-the-counter (OTC) cough and cold drugs marketed for pediatric use. The hearing comes after more than a year of concerning reports on these nonprescription drugs and their safety and efficacy for children under age 6.
FDA is developing a proposed rule to revise the pediatric labeling contained in the Final Monograph for Cough, Cold, Allergy, Bronchodilator, and Anti-asthmatic Drug Products for Over-the-Counter Human Use, according to the agency announcement. The hearing is meant to provide FDA with input about certain scientific, regulatory, and product use issues as it proceeds with the rulemaking and reviews new drug applications (NDAs) for related drug ingredients.
To provide background, in March 2007, a group of pediatric healthcare practitioners petitioned FDA to amend the OTC drug monograph in 21 CFR part 341 so that the labeling for antitussive, expectorant, nasal decongestant, antihistamine, and combination cough and cold products would not be used for children under age 6 because the products have not been found to be safe or effective in that age group. In addition, according to FDA’s hearing announcement, the 2007 petition asked FDA to notify manufacturers of products whose labeling either uses such terms as "infant" or "baby," or displays images of children under age 6, that such marketing is not supported by scientific evidence and that manufacturers will be subject to enforcement action.
FDA convened a joint meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee in October 2007 to discuss the safety and efficacy of these OTC cough and cold products. The 22-person committee was “nearly unanimous in agreeing that new studies were necessary because extrapolation of efficacy data for the common cold indication from adults to children was not acceptable for children less than 2 years old or for children 2 years to less than 12 years.” The committee also voted 13 to 9 to recommend that pediatric cough and cold drugs should not be used for children under 6 years of age while rulemaking proceeded, and voted 15 to 7 to recommend that the products could, continue to be sold for use in children ages 6 to under 12 while new studies are conducted.
Wyeth, Prestige Brands, Johnson & Johnson, and Novartis did voluntarily withdraw related medications for children under age 2 last October.
In January of this year, FDA issued a Public Health Advisory recommending that these drugs not be used to treat infants and children under 2 because serious and potentially life-threatening side effects can occur. The advisory also indicated that FDA had not yet completed its review of the safety of these medicines in children aged 2 to 11; the agency committed to completing the review as quickly as possible.
Since that time, FDA has been reviewing available data concerning the use of cough and cold medications in children and, ultimately, noted that children under age 4 are more likely to experience non-allergic adverse events than older children. However, given that 1 in 10 children uses one or more cough and cold products during a given week with exposure being highest among 2 to 5 year olds, and high in children under 2.4 years old, according to a recent report, the agency has noted that serious adverse events are relatively rare given the extensive use of the drug products.
However, according to the public hearing announcement, FDA is interested in obtaining public comment on these issues, including: What types of studies should be conducted to assess effectiveness and/or safety, and to determine appropriate dosing of cough and cold ingredients in the pediatric population? What is the most appropriate method for determining pediatric doses? Can measurement errors in dosing be reduced using more standardized measuring devices or alternative dosage forms?
The hearing will be held from 8 am to 5 pm, Oct. 2, at the Sheraton Washington
North Hotel, 4095 Powder Mill Rd., Beltsville, MD 20705. Comments and written registration can be submitted to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, or online, at www.regulations.gov. Registrations are due Sept. 15; comments are due Dec. 2.
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