FDA Denies Plan in Works to Restrain Cough and Cold Medicines

ROCKVILLE, Md., Oct. 3 -- The FDA has clarified reports by some major media suggesting that the agency has plans for new regulations on over-the-counter cough and cold medications for children.

In an unusual press release, the agency pointed out that the recommendations it posted on its Website, as part of a 356-page briefing document, were merely unvarnished views of staffers. They were drafted in preparation for deliberations a couple of weeks hence by the FDA's Nonprescription Drug Advisory Committee on over-the-counter cough and cold medications.

Contrary to the impression conveyed by the press reports, the FDA said, nothing had happened yet. The staff recommendations to discourage decongestant use by children younger than two years old, and antihistamines by those younger than six, were essentially talking points for a meeting that hasn't happened.

"FDA has not called for a ban on medicines for children under six," said the FDA statement. "Rather, the agency has presented a variety of internal and external recommendations for discussion at the upcoming advisory committee meeting," she said.

An Associated Press story, picked up by news outlets worldwide, had put it this way:

"The preliminary recommendation, from Food and Drug Administration safety officials, would apply to decongestant use in children under 2, and antihistamines in those younger than 6, according to agency documents released Friday."

The FDA said no conclusion had been reached, or decision on any action to be taken, in response to a citizen petition, "After hearing the recommendations of the advisory committee, FDA will determine the course of action."

An action taken by the FDA that did happen may have led to some confusion. The agency said it was asking the makers of more than 200 unapproved cough suppressants containing hydrocodone to remove the products from the market.

Joshua M. Sharfstein, M.D., the commissioner of health for Baltimore, filed the citizen petition to the FDA that sparked the advisory committee review.

The petition, co-signed by chiefs of pediatrics from Johns Hopkins and other Baltimore-area hospitals, called on the FDA to issue a statement explaining to the public that OTC cough and cold products have not been shown to be safe and effective in children under six, and to mandate that product labels be changed to state that. The signers also asked that the agency require labels to state that "these products should not be used for treatment of cough and cold in children under six."

The petitioners also urged the FDA to crack down on companies that market infant or pediatric formulations of antitussives, expectorants, decongestants, antihistamines, or combinations.

The petition was included in the briefing document, available on the FDA web site. The document also includes supporting material from the agency's Adverse Event Reporting System, American Academy of Pediatrics, and American Academy of Family Physicians, and other professional groups, and responses from the OTC maker Wyeth and the Consumer Healthcare Products Association (CHPA), an industry advocacy and lobbying group.

The briefing document is available for viewing or download at http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4323b1-02-FDA.pdf.