The FDA has delayed announcing its new pediatric cough and cold medicine dosing guidelines, according to the Tan Sheet. The guidelines were due to be released in June 2010, but have been pushed to December 2010.
The chief catalyst for the revised guidelines was a citizen petition filed in 2007 by then-Baltimore Health Commissioner Joshua Sharfstein and other pediatricians, demanding that the FDA visit the safety requirements and standards for over-the-counter (OTC) pediatric cough and cold medication. Such medications, marketed for children, are not subject to any required efficacy standards and have been linked to infant deaths.
The agency responded by recommending that children under 2 not be given OTC cough and cold meds and formally reviewing its standards. In 2008, makers of those products voluntarily changed labeling to suggest such drugs not be administered to children under 4. Last year, Sharfstein was named Principal Deputy Commissioner for the FDA, where he has led drug safety efforts.
Though the process is a slow one, Sharfstein told the Washington Post in 2008 that this is how change is made. From the PostScript archives:
…the agency has scheduled a meeting on Oct. 2 to consider questions about whether the products should be proven effective or safe to remain on the market, and if so, how. Baby steps? Maybe. But experts say this is how it gets done.
“This is how the agency can take these products off the market,” Baltimore Commissioner Joshua Sharfstein told the Post. “I think this signals the agency is going to apply a modern standard of safety and efficacy to these products, and that is a standard these products cannot pass.”
Sharfstein knew, then and now, that regulation of a sprawling and complex industry like drugs is a deliberate process that takes time to get right. The agency’s recent steps toward increased transparency, boosting and upgrading its capacity at the Office of Regulatory Affairs, and a willingness to request additional authorities to better protect Americans’ food and prescription drugs all suggest that the rules on pediatric cough and cold meds, when they come out, will line up with the FDA’s renewed focus on making drugs safer.
–Kate Petersen, PostScript blogger