FDA may reevaluate policy on pediatric prescription drugs
WASHINGTON The recent announcement from the Food and Drug Administration’s Nonprescription Drugs and Pediatric Advisory Committees involving over-the-counter cough and cold medications could possibly call for the agency to reevaluate its policy on data concerning prescription medications.
The committees voted 21-1 that it was not appropriate to extrapolate data from adult clinical effectiveness studies to children between the ages of 2 and 12.
John Jenkins, director of the Office of New Drugs, said that many prescription antihistamines often are formulated in combination with such ingredients as antitussives and decongestants and the FDA does not require manufacturers to demonstrate that the combinations are effective. He apparently backed off from his statement during the meeting on Oct. 19 regarding the reevaluation of drugs that treat allergic rhinitis, saying the agency will have to look at the impact of the committees’ recommendations.
FDA committee to review OTC decongestants
ROCKVILLE, Md. The Nonprescription Drugs Advisory Committee will consider the possibility of a revision to the final monograph for over-the-counter decongestants following a review of the safety and efficacy of phenylephrine in a Dec. 14 meeting, FDA said in a notice prepared for the Oct. 24 Federal Register, according to the Tan Sheet.
The meeting is one day after the FDA considers the potential switch of Merck’s Mevacor for the third time.
At the Dec. 14 meeting, the committee will discuss questions on the safety and effectiveness of PE hydrochloride and PE bitartrate in nonprescription decongestants raised in a Feb. 1 citizen petition.
The petitioners—University of Florida pharmacy professors Leslie Hendeles and Randy Hatton—assert that available data does not support the adult and pediatric dosing levels recognized as safe and effective in the monograph for OTC cough, cold, allergy, bronchodilator and antiasthmatic drug products. They requested FDA revise the monograph to increase the adult dose of PE hydrochloride from 10 mg to 25 mg and PE bitartrate from 15.6 mg to 40 mg.
Last week a pair of FDA advisory committees voted to discontinue the recommendation of children’s cough-and-cold remedies for children under the age of six.
NPA to hold Web conference on adverse-event reporting law
WASHINGTON The Natural Products Association on Monday announced the scheduling of a Web conference this Friday at 2 p.m. featuring two experts—Rick Kingston, president, regulatory and scientific affairs, SafetyCall International and Daniel Fabricant, vice president of scientific and regulatory affairs, Natural Products Association—to help companies understand both the broad and technical aspects of the new adverse-event reporting law.
“As the largest trade association representing both retailers and manufacturers, I can say there are a lot of questions and confusion about how these new rules will work,” Fabricant stated. “Every company needs to know and understand this new law and its ramifications, which is why we are conducting this special session. We will also use the knowledge gained from this session to inform our official comments that we submit to the FDA.”