Second Congress official pens letter to FDA; recall could cost industry millions

WASHINGTON Rep. Rosa DeLauro, D-Conn., on Friday released a letter questioning how the Food and Drug Administration would oversee a voluntary kids cough-cold products label change that industry initiated last week. According to the letter, DeLauro is asking for a more immediate label conversion than allowing for products carrying old labeling to be sold through. If retailers and manufacturers are pressured to recall products carrying older labels, the costs associated with removing those products out of the supply chain could run into the tens of millions across the industry, one supplier of those cough-cold products suggested.

“Earlier this week, at the urging of the FDA, drug manufacturers announced that they will not market over-the-counter cough and cold medicine to children under the age of four-year and they will be relabeled to reflect that,” the letter stated.

“With the cough and cold season upon us, it is absolutely critical that these labels be changed expeditiously to avoid confusion and protect the health of children,” she said. “I am concerned that, if this transition takes that long [the 2008-2009 cough and cold season], the label change will have no practical effect for another year. … Although this label change is voluntary, and the result of discussions with the FDA, it is imperative that the agency do everything in its power to ensure that the medicine with the old labels are removed from store shelves quickly and replaced with the new labels. The FDA needs to act immediately so that the transition to the new label does not take longer than the upcoming cough and cold season.”

Given the urgency of the situation, DeLauro also pressed the agency for additional information on how it intends to pursue this label change, asking for responses to the following questions by Oct. 21, 2008:

• How does the FDA plan to oversee the label change?

• What resources, including funds and personnel, will be devoted to overseeing the label changing process?

• Has the FDA developed a timetable for the transition to ensure that the label changes are made before the start of the cough and cold season?

• Is FDA aware of an industry timetable for the transition to the new labels? If so, what is it?

• Given that the CHPA announcement was partly due to negotiations with the FDA, how does the agency intend to enforce the label change?

According to published reports, the voluntary announcement to switch cough-cold labeling that recommends parents not use cough-cold medicines in children under the age of four was borne out of a negotiations between the Consumer Healthcare Products Association and FDA held earlier this year.