- FDA recommends health professionals prescribe no more than 325 mg of acetaminophen per dose
- FDA advisory panel to consider OTC status of NSAIDs
- Prestige Brands solution to pediatric overdosing — unique squeezable, single-dose APAP packet
- FDA advisory committees vote against changing naproxen label to highlight a lower CVD profile
- USPLabs agrees to recall and destroy dietary supplement following FDA actions
NEW YORK While the impetus for this multiple advisory committee meeting and the Food and Drug Administration’s working group that first examined this issue had been in the works long before the Obama administration took office — and consequently the new FDA took hold — there has been some concern that an overly zealous agency is placing any shred of safety concern ahead of consumer access — no matter how miniscule that safety risk may be.
In that regard, and so long as the FDA acts on the recommendations made by its advisory committees as is typical, the outcome of last week’s meeting isn’t as bad as it could have been. Combination APAP products are likely not to be recalled, which is good news beyond just McNeil Consumer and its Tylenol franchise. Also what-would-have-been-costly pack-size limitations, such as limiting the number of daily doses merchandised in each SKU to no more than three appears to also be off the table based on committee recommendations.
Those two actions would have been costly to manufacturers and retailers alike, especially as that would have resulted in a potential wholesale recall of products already in the supply chain. And if manufacturers are able to sell-through the current maximum dosing of 1,000 mg, then the overall cost to the industry will be relatively less.
The problem that remains, however, is public perception around the safety of acetaminophen, which by all accounts is safe when used as directed. And that’s going to be a problem in the coming weeks as the story of the committee meeting makes its way through the news cycle, and again when the FDA announces any changes it will make regarding the sale of OTC and prescription-only acetaminophen products in the coming months.