FDA Withdraws Final Rule on Acetaminophen, NSAID Products

The FDA withdrew a final rule from the Office of the Federal Register, which would have cost drugmakers an estimated $32.6 million to revise labeling on OTC acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs) to include the risks to the liver, heart or other organs. The agency withdrew the rule, which it initially made available on its website, to comply with a Jan. 21 memo from White House Chief of Staff Rahm Emanuel requesting that rules not yet published be withdrawn so they could be reviewed by a department head approved by the president.
Washington Drug Letter