Off-Label Promotion Has Legal Limits

While recent legal developments have loosened legal strictures around truthful, non-misleading, off-label promotion of drugs, there are legal limits to an off-label promotion strategy.

Here are several key limits to off-label drug promotion.

Reclaiming First Amendment Protection for some off-label promotion

Off-label drug promotion refers to making therapeutic claims for intended uses of a drug that have not been approved by FDA.

As an example, results of clinical trials might be used to promote the product, even if not yet sufficient to make the case that the drug is safe and effective for its intended use.

Although federal courts have slammed many companies—with large penalties—for off-label promotion of FDA-approved Rx drugs, some courts recently have extended First Amendment, freedom of speech protection to truthful, non-misleading claims.

FDA is also reviewing its policies on off-label promotion.

We know that in general, FDA does not interfere with the practice of medicine—i.e., including practices by individual physicians to make off-label recommendations of drugs to their patients. This is within the purview of state licensing law and state medical boards. (See FDA, "Off-Label" and Investigational Use Of Marketed Drugs, Biologics, and Medical Devices - Information Sheet.)

Because of some general loosening of legal restrictions, we will likely see manufacturers and distributors move somewhat into off-label promotion. This is, however, not without legal risk.

Off-Label Drug Promotion: Big Caveats

Several big caveats are important here:

  1. Off-label protections have only been applied to off-label promotion of approved FDA drugs, but not to unapproved products (such as homeopathic drugs, which do not go through the new drug approval process).
  2. Product claims still have to be lawful (i.e., within what is allowed if the product is, for example, a homeopathic drug or dietary supplement).
  3. Product claims that involve treatment cancer will be especially subject to regulatory scrutiny, since cancer has been an FDA enforcement hot button.
  4. Product claims must be substantiated—i.e., capable of proof by competent and reliable scientific evidence.

And so, with all things, FDA and FTC, there is legal complexity. We can’t just assume that because there have been some recent development affording more protection for off-label promotion, that these practices will inherently be immune from regulatory scrutiny.

This is a continually shifting regulatory landscape, so stay tuned on this blog for further developments.

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