John Osborn and Seth Ray
First published June 29th, 2018
The Trump administration has issued final guidance that allows drug companies and device makers to provide health care economic and other supporting information to payers and formulary committees, even if the information is outside of the FDA approved labeling and was not submitted to the agency in the course of product approval. This is a welcome and long-overdue development, one that raises the question of whether the agency will take steps to allow companies to provide truthful off-label information to physicians and patients in other contexts.
Health care economic and other supporting information, known as HCEI, can include clinical data or other evidence that attempts to measure or describe the economic outcomes or health consequences of using a drug or device, and may be evaluated in comparison with other health care interventions or with no intervention at all.
In April, FDA Commissioner Scott Gottlieb signaled that an expanded safe harbor was coming soon that would provide a “more robust framework” to allow companies to discuss the value proposition and health economic benefits of off-label uses. He was quoted at a presentation made to a payer group that the FDA would not want to insinuate itself into those discussions “just because it wasn’t studied in the context in which it was submitted to the agency.”
That is rather interesting, because when it comes to discussing clinical and medical information about unapproved uses with physicians and patients, the FDA’s policy for decades has been to limit companies from speaking — even if the information is truthful and not misleading. Gottlieb himself has written, in his days as a private citizen and policy advocate for the American Enterprise Institute, in support of loosening the restrictive standards imposed by the FDA’s Office of Prescription Drug Promotion and enforced by the Department of Justice.