On February 7, 2017, the Food and Drug Administration (FDA) delayed implementation of its January 9, 2017, final rule addressing the regulation of tobacco products as drugs, devices, or combination products. That rule, which also amended the intended use regulations for drugs and devices, was to go into effect today, February 8, 2017; however, implementation has been delayed until March 21, 2017, pursuant to a January 20, 2017 memorandum from the Assistant to the President and Chief of Staff, Reince Priebus. The January 20 memorandum, entitled “Regulatory Freeze Pending Review” (82 FR 8346), directed the heads of Executive Departments and Agencies to temporarily postpone the effective dates of all regulations that had been published but had not yet taken effect in order to allow for review of the “questions of fact, law, and policy” raised by these regulations.
As noted in our prior alert, the final rule amends the last sentence of 21 C.F.R. § 801.4 (for devices) and 21 C.F.R. § 201.128 (for drugs) to clarify that a manufacturer’s knowledge, alone, that its legally marketed product is prescribed or used by physicians for an uncleared/unapproved use is not proof in and of itself that the manufacturer intends such use, nor is it sufficient to trigger the obligation to provide adequate labeling for that unapproved use. The amended language clarifies that a new intended use is created only if the totality of the evidence shows that the manufacturer objectively intends for a drug/device to be used for uncleared/unapproved conditions or purposes. In other words, the amended language clarifies that knowledge alone is not enough, but at the same time, preserves the ability of FDA to rely on knowledge of unapproved uses as part of an assessment of the totality of evidence.