An FDA joint advisory panel will vote on prioritizing the agency's options concerning whether to take certain types of over-the-counter acetaminophen products off the market in addition to voting on the proposed options.
"The Tan Sheet" is following every word and noting every presentation today as FDA kicks of the two-day meeting of the nonprescription drug, safety and risk management and anesthetic drug advisory committees.
Reporters Elizabeth Crawford and Christopher Walker are there, and Walker is posting notable developments – such as FDA officials' indication that the panel will vote on ranking the agency's priorities – on Twitter as well as here on Over the Counter Today.
To reduce the risk of acetaminophen overdose, an internal FDA working group proposed options including eliminating the ingredient from all OTC combination products, reducing maximum available tablet strength to 325 mg, lowering the daily adult dose, standardizing liquid suspensions with the ingredient and limiting package size.
Crawford's piece on drug manufacturers' take on FDA's possible acetaminophen actions from this week's issue of "The Tan Sheet" is here.
"The Tan Sheet" next week will offer more reporting from the June 29-30 meeting, and break down what the experts' recommendations mean for manufacturers and other stakeholders in the OTC market.
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-- Malcolm Spicer (m.spicer@elsevier.com)
