Over at the Drug And Device Law Blog, our colleagues call attention to proposed changes to the “intended use” regulations for prescription drugs and devices, 21 C.F.R. §201.128 and 21 C.F.R. §804.1, somewhat hidden within a proposed rule regarding tobacco published in the Federal Register on September 25, 2015.
As the FDA explained, the changes are intended to reflect that “the Agency does not regard a firm as intending an unapproved new use for an approved or cleared medical product based solely on that firm’s knowledge that such product was being prescribed or used by doctors for such use.” 80 Fed. Reg. 57756, 57761 (Sept. 25, 2015) (emphasis added). As the Drug and Device Law post observes, one authority relied upon by the FDA in proposing this change was a brief it filed regarding First Amendment issues and off-label promotion in Allergan Inc., v. United States of America, 2010 WL 11211158 (D.D.C. Jan. 11, 2010) (FDA’s Motion to Dismiss or for Summary Judgment).
While the First Amendment implications of truthful, non-misleading off-label promotion, discussed in our prior posts, might well support additional changes to the intended use regulations, this is a small step in the right direction. The revised language would be effectively the same for drugs and devices. The proposed revised version of 21 C.F.R. §201.128, for example, are reflected below in redline: