By Lyle Dennis
A joint advisory committee to the Food and Drug Administration has voted to urge the FDA to take a number of steps that will change the way acetaminophen products are marketed to consumers in the United States.
Following a day and half of listening to testimony from a variety of experts in the field, including key AASLD members Dr. Will Lee, who was a guest speaker, and Dr. Tim Davern, who was the lead-off witness during public testimony, the joint advisory committee voted to make the following recommendations to the FDA:
• In what was probably the biggest decision of the meeting, the committee voted 20-17 to recommend to the FDA that it eliminate prescription acetaminophen combination products.
• By a vote of 21-16, the committee voted to recommend that the FDA lower the current maximum daily dose of acetaminophen from its current level of 4000 mg/day. No specific dose was specified.
• By a vote of 24-13, the committee then recommended that the single, non-prescription adult dose be reduced to 650 mg.
• Following those two actions, the committee then voted 26-11 to recommend that the current maximum single dose (2 x 500 mg) become available only by prescription.
• By a vote of 36-1, the committee voted to recommend that there be only one concentration of non-prescription acetaminophen liquids for pediatric patients, although there was mixed opinion on whether it should be at the more concentrated infants formulation or the less concentrated children’s version.
• By a vote of 27-10, the committee recommended that “unit of use” packaging be required for any prescription acetaminophen products that remain on the market.
• By a vote of 36-1, the committee recommended a black box warning be included for any prescription acetaminophen products that remain on the market.
There were two options discussed that were defeated in votes by the joint committee:
• In a 17-20 vote, the committee opted not to recommend that the FDA seek to change the maximum size of the packaging for non-prescription acetaminophen.
• In a 13-24 vote, the committee recommended against eliminating non-prescription acetaminophen combination products from the market.
Following these votes, the committee was asked to advise the FDA of what actions they put the highest priority on achieving. On that question:
• 13 supported reducing the maximum daily single and daily dose and/or switching the 2 x 500 mg dose to prescription.
• 7 felt the single OTC pediatric formulation was most important.
• 7 indicated that eliminating prescription acetaminophen combination products was most important.
• 7 thought the boxed warning for prescription combination products that remain on the market was most important.
• 2 members cited the elimination of OTC combination products, and
• 1 thought that “unit of use” packaging should be the highest priority.
This meeting was a joint session of three FDA advisory committees: Drug Safety and Risk Management; Nonprescription Drugs; and, Anesthetic and Life Support Drugs, involving a total of 37 members.
The recommendations made by the joint advisory committee are not binding on the FDA, which makes the final decision. However, most often, the agency follows those recommendations of expert panels that it constitutes.
Additional information about the meeting will be posted on the FDA’s website (www.fda.gov) and is also available from various trade and general press sources.
Click here for the history of AASLD’s partnership with the FDA and PhRMA