Off-Label Promotion: Are FDA’s Rules About to Unravel?

State and federal legislators are prepping changes that would give wider latitude to pharmaceutical manufacturers and unravel FDA rules on off-label promotion, according to a new editorial in PLOS Medicine from Drs. Michael Sinha and Aaron Kesselheim of the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School.