Speaking of Dr. Sharfstein, what's the status of that pediatric cough/cold petition? FDA is still working on a proposed rule to amend the monograph. Read about that in the Tan Sheet here.
Meanwhile, the trade association for OTC drug manufacturers, the Consumer Healthcare Products Association, has filed comments with the agency saying an OTC-to-Rx unswitch of the products would have a negative public health impact. Read their 384 pages of comment here. Or read The Tan Sheet's story here or below:
Pediatric Cough/Cold “Reverse Switch” Will Not Increase Safety – CHPA
A potential "reverse switch" of pediatric cough/cold OTC drugs to prescription status would not address concerns about misuse of the products, the Consumer Healthcare Products Association says.
Moving pediatric cough/cold OTCs to Rx status would "create unnecessary administrative effort and expense," and have "a negative socioeconomic and public health impact," the trade group says.
CHPA argues against a reverse switch in its Dec. 2 comments on FDA's questions about revising the OTC monograph for cough, cold, allergy, bronchodilator and anti-asthmatic drug products.
Prescription status would not "address the predominant root cause of the serious adverse events - accidental ingestion and misdosing or misuse, which can still happen with prescription products," the trade group says.
CHPA also argues that switching pediatric cough/cold products to Rx status "is not a practical or efficient way to actually address whether the products have been shown to be safe and effective for pediatric" use.
The "ultimate resolution" to ensure safety and efficacy of pediatric cough/cold products is to conduct additional pharmacokinetic studies to determine appropriate dosing, according to CHPA's comments.
"Although there are significant data to show the effectiveness in adults, the body of evidence is not as robust in children in favor of cough and cold medicines."
The trade group says it already is conducting studies to confirm appropriate pediatric doses and "to reaffirm the science supporting" the eight ingredients in the monograph.
Testing of each ingredient is different, but will include integrating and bridging existing and new data, CHPA says.
CHPA says another alternative to a reverse switch is to revise OTC labels to ensure appropriate use.
For example, "in an abundance of caution" the industry already voluntarily revised labels to warn consumers not to give the products to children under 4 years of age and not to use antihistamine products to sedate or make a child sleepy, CHPA says.
FDA began considering revising the cough/cold monograph and asked about switching the pediatric products to prescription status in response to concerns in a 2007 citizen petition, which said the drugs were not safe or effective for children under 6 years old.
The petition triggered a joint meeting of the Nonprescription Drug and Pediatric advisory committees in 2007. The panel recommended children up to 6 years old should not use OTC cough/cold medicines, but said the products are safe for children 6 to 12 years old.
[Editor's note: Read more about this topic in "The Tan Sheet," your source for nonprescription pharmaceutical and nutritional industry news. For more information call 1-800-332-2181.]
- Elizabeth Crawford (e.crawford@elsevier.com)
