Congressman calls for removal of kids cough-cold
WASHINGTON The House Oversight and Government Reform Committee, chaired by Rep. Henry Waxman, D-Calif., called on the Consumer Healthcare Products Association on Tuesday to endorse the voluntarily removal of all cough-cold products marketed by its members toward children under the age of 6.
In a letter to CHPA president Linda Suydam, Waxman wrote, “The [FDA advisory panels] found that while there was no evidence that [cough-and-cold] products were effective in children under the age of 6, there was evidence that some children had been harmed, and have even died, from taking these products. This recommendation comes on the heels of the voluntary withdrawal by Consumer Healthcare Products Association of products marketed for use in children under 2.”
Waxman commended CHPA’s voluntary withdraw of products marketed for use in children under 2 years old, but expressed disappointment that CHPA is reportedly prepared to fight the advisory committee’s recommendation on cough-cold products for children under 6 years old. “I had hoped that CHPA would show the same leadership and interest in protecting the health and well-being of children under the age of 6 as it showed toward children under 2 by similarly withdrawing those products,” Waxman wrote.
“I sincerely hope that CHPA will take prompt action to ensure that the advisory committee’s recommendations are promptly carried out by your member companies,” Waxman concluded. “There is no need for CHPA to wait for the FDA to complete what will surely be a lengthy rule-making process to change the monograph for these products. American children cannot afford that kind of delay.”
Waxman has expressed a personal interest in the outcome of the original citizen’s petition—which calls for a ban on cough-and-cold products for children under the age of 6. The lead petitioner is Waxman’s former senior aide, Joshua Sharfstein, who left Waxman’s office to assume the position of Baltimore’s commissioner of health. As an aide to Waxman, Sharfstein led congressional investigations on tobacco control, healthcare disparities, substance abuse and HIV.
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.”