FDA’s Interesting Off-Label Memo


The FDA recently posted a memorandum spelling out the agency’s views regarding off-label promotions, a document chock full of interesting observations. This discussion is now taking place in a somewhat different political backdrop, however, particularly in light of the dismissal of a high-ranking and well-known member of the Department of Justice. The picture in aggregate is highly fluid – which may or may not portend change – but which nonetheless is almost certainly unsettling to those at the FDA who prefer the status quo where off-label promotion is concerned.

When a solution is not a solution

The January 2017 FDA off-label memo offers the expected rationale for the agency’s current views on commercial speech, including that the requirement to conduct studies of a drug or device for a specific indication does a lot to provide assurance that the therapeutic in question will do more good than harm.

The memo takes a turn for the peculiar, however, when the FDA takes credit for things such as patent protection, which most would say redounds to the credit of the statute and the Patent and Trademark Office. Subsequently, the memo offers alternatives to the current state of affairs, such as a ban on off-label use of drugs and devices, and the application of a higher level of taxation on off-label use.

The problem with these and a couple of others of the FDA’s alternative commercial speech universes is that they are entirely outside the agency’s jurisdiction. For instance, it is quite well known that off-label use is within a physician’s discretion, and doctors are not regulated by the FDA. Not yet, anyway. As for tax policy, there’s no need to explain why this is outside the agency’s statutory authority.

There are several items of interest where context is concerned, not the least of which is that Robert Califf has resigned from the FDA commissioner’s chair, leaving the Trump administration with a very interesting job to fill. A number of names have been floated for that opening, including that of Scott Gottlieb, whose curriculum vitae includes a stint as one of the FDA’s deputy commissioners. Gottlieb has voiced reservations about the agency’s standards regarding off-label speech, but other candidates of record, including venture capitalist Balaji Srinivasan, are unknowns where the off-label discussion is concerned.

All in all, attorneys at the FDA have to assume the commercial speech question is likely to weigh against the agency in the months and years ahead, even if nothing in the way of legislation surfaces.

More than one new face at DoJ

One interesting bit of context here is the dismissal of Sally Quillian Yates, she of the famed Yates memo, which some believe comes up only a little short of the extortive tenor of the Thompson memo. President Trump gave Yates the axe for announcing that DoJ would not mount a legal defense of the administration’s executive order on immigration from six nations said to harbor terrorists. Whatever one believes about that executive order – and it should be noted that recent developments do not necessarily portend a revisitation of the memo that bears Yates’ name – her dismissal sends an unmistakable signal that employees of the federal government can press their luck only so far.

Clearly it’s too early to anticipate what will become of the off-label discussion, but this issue has occupied a tremendous amount of time and effort at the FDA, and these developments can’t help but embolden adversaries of the agency’s current stance on the commercial speech/First Amendment question. Change may or may not be in the offing, but it needn’t start with the executive branch of the federal government. It may come in the courts, and whomever the Trump administration appoints to the job of solicitor general may have some very interesting things to say, indeed, if the matter ever reaches the Supreme Court.

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