Regulatory Focus™ > News Articles > Group to FDA: Use Enforcement Discretion to Allow Pediatric Labeling Updates on OTC Tylenol

Group to FDA: Use Enforcement Discretion to Allow Pediatric Labeling Updates on OTC Tylenol

Posted 21 August 2013 | By Alexander Gaffney, RAC

A new Citizen Petition filed with the US Food and Drug Administration (FDA) by the Consumer Healthcare Products Association (CHPA) seeks to allow additional information to be placed on over-the-counter (OTC) acetaminophen products with the intent of making it easier to give accurate doses to young children.


Children have been a historically under-represented population in drug trials, largely due to ethical conundrums. Many companies first seek approval for a drug product based on studies in adults, with obtained data then used to support additional populations.

The problem, however, is that subsequent trials on children (if warranted by the probable or intended use of the product) are often times slow to get underway, if they ever do at all. While several pieces of legislation have been enacted both to compel and incentivize these studies (the Best Pharmaceutical for Children Act and the Pediatric Research Equity Act), many gaps still persist, resulting in a lack of clarity on what doses are appropriate for children to take.

And in other cases, while safe prescribing habits are known, that information has been obtained through third-party studies unaffiliated with the drug's sponsor, leaving consumers in a curious position where the best prescribing information for a product isn't available on the product's labeling.

The Case of Acetaminophen

And such is the case with acetaminophen, a widely used painkiller product that has for decades been available as an OTC product available without a prescription. While it has been subject to some repeated safety warnings regarding its use, which has been shown to cause liver problems with prolonged use or overuse, it has largely been shown to be safe when properly used.

But, as CHPA's Citizen Petition to FDA notes, safety is a relative term contingent upon the ability to properly consume the correct amount of product. And for those between the ages of six months and two years of age, there is no dosing information on the labels of single-ingredient acetaminophen OTC drugs.

"Lack of dosing information on product labels may lead to medication errors and adverse events," CHPA observed.

The group said its argument is supported by two FDA Advisory Committee panels, which in both 1997 and 2011 recommended that the labeling be affixed to the products to promote its safe use in younger children.

But for whatever reason, those recommendations were never acted upon by FDA, CHPA said.

Rather than requiring all current acetaminophen manufacturers to submit supplementary applications for new labeling additions, CHPA recommended FDA utilize its oft-used enforcement discretion to allow companies to update their labeling. Then, later, "Once pediatric dosing information is permitted via the FDA OTC monograph rulemaking process, enforcement discretion no longer will be needed," the group said.

The Citizen Petition has not yet been posted to FDA's public docket, but a copy is available on CHPA's website.

CHPA Citizen Petition

CHPA Statement

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