HEALTH

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

BY Michael Johnsen

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.

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Senator calls for FDA ban on sale of cough-cold medicines for children under six

BY Michael Johnsen

WASHINGTON Sen. Chris Dodd, D-Conn., senior member of the Senate Committee on Health, Education, Labor, and Pensions and chair of its subcommittee on Children and Families, earlier this week called on the Food and Drug Administration to ban the marketing of children’s cough-cold formulations for children under six even as industry made the announcement they would no longer market use of those medicines to children under four years of age.

“While I’m pleased to see that the drug companies are voluntarily taking some steps to ensure the safety and well being of our children, I am disappointed that the FDA has not followed the recommendations of its own advisory panel,” stated Dodd.  “I strongly urge the FDA to take swift action to ensure the safety and efficacy of these products in young children before one more child is given a medicine that may not only be ineffective but could also be harmful.”

In a letter to FDA commissioner Andrew von Eschenbach, Dodd wrote, “Nearly a year has passed since the FDA’s Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee voted 13 to 9 against the use of over-the-counter cough and cold medications in children ages two to six. Another cold and flu season is right around the corner, yet commonly available medical products continue to be marketed and sold to the parents of young children even though they have not been shown to be effective and experts have raised serious questions about their safety.”

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Hylands offers parents relief to children’s cough-cold medication worries: homeopathic remedies

BY Michael Johnsen

LOS ANGELES Hyland’s helped position homeopathic alternatives to allopathic cough-cold medicines as a viable alternative to parents seeking symptomatic relief for their children suffering from a cold in the wake of the Consumer Healthcare Products Association’s announcement earlier this week that those allopathic medicines should not be used for children under the age of four.

“Natural cough and cold medicines for children are not simply recent industry fads, but rather time-tested medications that are highly safe and effective,” stated Jim Sears, an expert in the field of pediatric medicine and advocate of natural medicines. “By being completely free of the active ingredients of concern to the FDA, homeopathic medicines provide symptom relief for children and peace of mind for parents everywhere.”

“It all comes down to understanding what you put into your body and the bodies of your children,” added J. P. Borneman, chairman and chief executive officer of Hyland’s. “At Hyland’s we create the types of children’s medications that we feel safe giving to our own kids. Our medicines treat the cause of sickness safely and gently, without fear of side effects, and are manufactured according to FDA’s Good Manufacturing Practices.”

Hyland’s offers a complete line of gentle products to treat the cough and cold symptoms of children, including:

• Cough Syrup with 100% Natural Honey 4 Kids

• Cold ‘n Cough 4 Kids, New

• Cold Relief with Zinc 4 Kids Strips, due in stores this winter

• Sniffles ‘n Sneezes 4 Kids

• Complete Flu Care 4 Kids

• C-Plus Cold Tablets

• Cough Syrup with Honey

• Earache Drops

“If parents take anything away from this situation, they should understand that they are their child’s greatest defense against avoiding the dangers associated with the OTC medications causing concern,” Sears said. “Parents need to make sure they are educated on the benefits of natural medicines available to them and their children so they are not forced to decide between treating their child’s sickness and keeping their child safe.”

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