First published May 9th 2018
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.
The editorial coincides with a new push from the libertarian Goldwater Institute, which has already sought to undermine FDA with its “Right-to-Try” state and federal legislation, and is now targeting off-label promotion, as it said in a press release Wednesday that the government is “censoring the communication of valuable information.”
Tennessee’s law, which takes effect 1 July, says, “No state regulatory board may revoke, fail, or renew or take any other action against a pharmaceutical manufacturer’s or representative’s, healthcare institution’s, or physician’s license solely for engaging in truthful promotion of off-label uses.”
Sinha told Focus: “The content of these laws is focused primarily on lifting restrictions on pharmaceutical manufacturers’ interactions with physicians and payors, entities that have the power to prescribe and pay for medications. This is a problem because decades of evidence and experience shows how effective pharmaceutical marketing is at driving physician prescribing and payor coverage practices in ways that are not always consistent with data or optimal benefit for patients.”
But FDA has pushed back on the idea of opening up off-label promotions further.