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FDA Throws a “Regulatory Temper Tantrum” Rebuffing Off-Label Drug Promotion Proponents

FDA Throws a “Regulatory Temper Tantrum” Rebuffing Off-Label Drug Promotion Proponents | Pharma Industry Regulation |

After weeks of anticipation, the FDA has issued a lengthy memo about the extent to which so-called off-label information about medicines may be disseminated to physicians.


The 63-page missive essentially rebuffed many of the suggestions made by drug makers and others that support expanding pharmaceutical marketing. Meanwhile, the agency continues to seek comments while working to develop a final guidance (“FDA Extends Comment Period for Unapproved Use (Off-Label) Communications”;


Drug company “communications that are designed to cause the audience to reach safety or efficacy conclusions independent of, or not supported by, the available data are misleading, have the potential to harm patients, and lead to a waste of health care resources,” the agency declared.


The memo follows a public meeting held last November (here: to explore off-label promotion, which refers to materials that describe unapproved uses of a drug.


Although doctors are allowed to prescribe a medicine for an unapproved use, the agency pointed to concerns that physicians are not always well positioned to discern the information they receive. “Studies have found that health care providers overestimate their knowledge of what uses are FDA-approved for drugs and assume that many unapproved uses are supported by sound scientific evidence when they are supported by uncertain or no evidence,” the agency wrote.


The agency shot down several suggestions from the meeting, notably one that would permit drug companies to actively promote unapproved uses so long as disclosure is made. The FDA essentially rejected this out of hand by writing that patients may be harmed by a “return to an environment” where the public encounters claims based “conjecture or extrapolation from limited data, most of which is later found to be false or misleading.”


“They’re pulling out all the stops in pointing to the price to be paid from expanding off label use,” said Dr. Sid Wolfe of Public Citizen Health Research Group, who spoke at the meeting last November against industry efforts to widen off-label marketing.


Industry supporters, however, were miffed.


“This memo is a regulatory temper tantrum,” said Peter Pitts, a former FDA associate commissioner who heads the Center for Medicine in the Public Interest, a think tank that is funded, in part, by industry. “The memo is written to show that allowing the truthful, accurate, and non-misleading of information will cause the the earth to stop spinning on its axis, research into new indications to cease…and misleading and misbranded communications to proliferate.”


Aaron Kesselheim, an associate professor of medicine at Harvard Medical School who also heads the regulation, therapeutics, and law program at Brigham & Women’s Hospital, had this insight:


“It’s probably not a coincidence that it’s being published now, since the three names I’ve seen all be associated with a possible change in FDA leadership after Jan. 20 all have a very anti-regulatory ideology, and may look to change the FDA’s approach to regulating off-label marketing.”


Further Reading:

  • “Does FDA Guidance About Pharma Communications with Payors Open a Path to Off-Label Discussions?”;
  • “WLF Urges FDA to Abide by First Amendment, Lift Restrictions on Off-Label Communications”;
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