The U.S. Food and Drug Administration (FDA) has once again delayed a new policy related to off-label promotion. When the drug and device makers that have decried the agency’s approach are happy that’s not a good sign. This move marked the third delay of a new FDA policy for assessing the “intended use” of drugs and devices. The concept looks at whether products are intentionally being promoted for unapproved uses, which can lead to criminal misbranding charges or False Claims Act (FCA) liability. In a proposed rule on Jan. 12, the FDA said it intends to delay the new policy “until further notice.” The move follows a six-week delay announced in February and a one-year delay announced in March.
The disputed policy was contained in a broader final rule regarding intended use and tobacco regulation. Under the policy, regulators said they would consider “the totality of the evidence” when assessing intended use. Industry groups quickly objected calling the approach “vague and overbroad.”
Although industry groups praised the delay, their ultimate goal is to prevent the “totality of the evidence” standard from ever taking effect. The FDA has acknowledged the opposition, but cautioned that its delay “should not be construed to indicate that FDA has made any decisions” about the policy’s future. Hopefully, the FDA will continue to work diligently on the issues relating to intended use raised in the underlying rulemaking and will remain committed to rulemaking on this issue. Comments on the proposed delay will be accepted until Feb. 5. Hopefully, the FDA will not be adversely influenced by the powerful drug and device manufacturers and will protect consumers in this matter. There have been far too many abuses involving off-label use of drugs and medical devices.