The result of the joint meeting will affect such brands as McNeil PPC's Tylenol; Johnson & Johnson's Pediacare; Novartis Consumer Health's Triaminic and Wyeth's Robitussin and Dimetapp.
Depending on whether the FDA accepts the joint panel's recommendations, the OTC drug companies' recent actions suggest at least one company is willing to cede the under-two market: Wyeth says it is changing labels on Robitussin and Dimetapp to advise doctors and parents: "Do not use in children under two years of age."
The OTC industry trade group, the Consumer Healthcare Products Association, has also said it recommends that labeling for children under two read "Do Not Use" versus the current "Ask a Doctor."
The FDA's Nonprescription Drugs Advisory and Pediatric Advisory committees completed the two-day meeting to determine if over-the-counter medicines for children are safe -- or if they even work -particularly among the very young.
By midday Friday, the panels had come down firmly against the administration of antitussives, decongestants and antihistamines to children under the age of two, with all but one panelist voting that such a practice should be halted.
The voting panelists also said the practice of deriving doses for children by extrapolating from adult dosages is untenable. The vote was unanimous among 22 panelists present.
The same question, referring to children from age two to under 12, also got a near-unanimous "no." And all agreed that clinical studies in children with clinical endpoints are necessary to support efficacy in children.
The two-day panel also examined packaging to see if the way the drugs are dispensed posed dangers. On Friday, panelists said it does.
Panelists were asked by the FDA to comment on "the contribution of mis-dosing to the overall safety profile of these products for each age group, and how this should affect their availability as OTC drug products." All panelists voted that dosing devices ought to be required with liquid formulations, and that such devices should be standardized.
The American Academy of Pediatrics says studies show that these products are not effective in children under 6 and can have potentially serious side effects. The group also argued on Thursday that dosage guidelines for cold and cold mixtures are based on adult data and thus inaccurate for children anyway.
Although the FDA is not bound by the panelists' recommendation, it tends to take heed.
Members of the FDA committees are physicians, nurses, statisticians and patient representatives. They are health care providers, and many serve as professors/instructors in schools of medicine.