Last month, the Food and Drug Administration (FDA) made some changes to the regulatory definitions governing off-label use of drugs in the US, and pharma groups are seriously disgruntled.

A final rule was released by the FDA on the 9th of January, 2017, which amends the definition of “intended use” for drugs and devices. Under this new rule, a drug manufacturer must indicate on its drug labels whether it objectively intends, based on a “totality of evidence”, to promote its products for unapproved uses.

There are two issues with this new definition. Firstly, the change in definition of intended use, to include a “totality of evidence” standard, took pharma groups by surprise. Intended use is a concept that allows the FDA to gauge whether a company is intentionally marketing its drugs for off-label uses. In 2015, a proposed rule was released that seemed to suggest that the provision, that made manufacturers liable if they had knowledge of off-label uses of their products, would be scrapped. However, the final rule, released this year, states quite the opposite.

In a citizen petition, filed by three major organizations that collectively represent virtually all drug manufacturers, it is claimed that this change violates the Administrative Procedure Act because, as this definition was not included in the proposed rule, these groups were not given the opportunity to comment on the revised definitions. According to these groups, this is a highly unconstitutional policy change that has no bearing under current laws.

The second issue raised in the citizen petition is that, by giving the FDA wide latitude to police and regulate off-label drug promotion, there may be an influx of lawsuits against pharma companies and a self-imposed gag on free speech if companies are held liable.

The petition is calling for the final rule to be stayed and revised so that it is in accordance with the proposed rule. The FDA has responded by delaying the enforcement of the rule until at least the 21st of March, although this may be due to the regulatory freeze ordered by President Trump rather than in response to pharma’s complaints.

As it stands, the outcome of this issue is hard to predict, given that President Trump has promised to dramatically reduce regulation in the US and has yet to announce the new FDA commissioner. However, the new President’s administration looks likely to shake up the current healthcare system in a number of ways, and off-label drug usage might well be just the first of many issues the US drug industry will have to work through.