DeLauro Presses FDA on Details on Label Changing Process for Children's Cough & Cold Medicines

Congresswoman Rosa L. DeLauro (CT-3), chairwoman of the Appropriations Subcommittee on Agriculture—Food and Drug Administration, wrote to FDA Commissioner Andrew C. von Eschenbach, M.D. asking how the agency will oversee the label changing process for children's cough and cold medicines. 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.

"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. 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," DeLauro writes in the letter. "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 October 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?

Below is the text of the letter.

October 10, 2008

Andrew C. von Eschenbach, M.D.

Commissioner

U.S. Food and Drug Administration

U.S. Department of Health and Human Services

5600 Fishers Lane

Rockville, MD 20857

Dear Dr. von Eschenbach:

Given the recent announcement by the Consumer Healthcare Products Association (CHPA) that the manufacturers intend to change the labels for pediatric cough and cold medicines warning consumers that these products should not be used in children under four-years old, I expect the Food and Drug Administration (FDA) to oversee closely the label changing process.

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. In its press release announcing the change, CHPA indicated that "throughout the 2008-2009 cough and cold season, manufacturers will be transitioning" to the new labels. I am concerned that, if this transition takes that long, the label change will have no practical effect for another year.

The industry's announcement represents a positive step forward, but it still is very disappointing that the FDA never has insisted that these products be tested to determine their safety and efficacy. While CHPA has indicated that they intend to conduct pharmacokinetic studies to determine the appropriate dosage for children, it is unacceptable that they would do this without first determining whether the medicine is actually safe and effective for children. The FDA must play a strong role in this process by determining the scope of these studies.

As you know, this is the second consecutive cold season in which the industry has announced a change in their advice to parents about providing cough and cold medicine to children. Last year, the industry warned parents not to dispense medicine to children under two. As such, it is possible that there are still many mislabeled products on store shelves for the beginning of this year's cold season.

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.

Because of the urgency of this issue, please respond to the following questions by October 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?

Thank you very much for your consideration of this matter. The core of FDA's mission is to protect the public health, and nothing could be more paramount than protecting the lives of our children.

Sincerely,

ROSA L. DeLAURO Chairwoman

House Appropriations Subcommittee on Agriculture Rural Development, Food and Drug Administration,

and Related Agencies

Source