Pediatric Drug Rulemaking Open for Public Comment

Published on: 

ePT--the Electronic Newsletter of Pharmaceutical Technology

A public meeting is being held today to discuss over-the-counter cough and cold medications for pediatric use.

Beltsville, MD (Oct. 2)-A public meeting is being held today to discuss over-the-counter cough and cold medications for pediatric use. Called by the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER), the meeting is meant to provide the agency with public input as it proceeds with rulemaking for ingredients in these particular drugs.

Specifically, 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. In January of this year, FDA issued a Public Health Advisory recommending that cough and cold medications not be used to treat infants and children under age 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 over age 2.

FDA posted the agenda for the public meeting on Sept. 29, 2008. Nearly 30 speakers, representing health departments, medical universities, healthcare associations, hospitals, pharmaceutical companies, and more will present their thoughts on the issues at stake.

Government panel members include: Jane A. Axelrad, associate director for policy at CDER; John K. Jenkins, director at CDER’s Office of New Drugs; Gerald Dal Pan, director of CDER’s Office of Surveillance and Epidemiology; Charles Ganley, director of CDER’s Office of Nonprescription Products; Lisa Mathis, associate director on CDER’s pediatric and maternal health staff; Michael Levy, director of CDER’s Division of New Drugs and Labeling Compliance; Robert “Skip” Nelson, a pediatric ethicist in FDA’s Office of Pediatric Therapeutics, and Dan Budnitz, a medical officer in the Division of Healthcare Quality Promotion at the Centers for Disease Control and Prevention.


The meeting runs from 8 am to 5 pm, at the Sheraton Washington North Hotel, 4095 Powder Mill Rd., Beltsville, MD. The open public-comment period will be held from 3:30 to 4:45 pm.

Look for our coverage of the meeting’s results in next week’s ePT. Read more about this topic in "Public Comment on Cough and Cold Meds for Kids."