Off-Label Use

Our Off-Label Use lawyers counsels both individual clinicians and companies about FDA, FTC, and state law rules governing off-label use.

Off-label use is common among physicians, yet both practitioners and healthcare start-ups often need clear legal advice concerning off-label practices.

In U.S. v. Evers, the federal government charged Dr. Evers with misbranding a drug by using and promoting it for an off-label use (to treat arteriosclerosis instead of simply as a chelating agent). Dr. Evers’ off-label use was not itself considered illegal, since the FDA stated that a physician can, “as part of the practice of medicine, lawfully prescribe a different dosage for his patient, or may otherwise vary the conditions of use from those approved in the package insert, without informing or obtaining the approval of the Food and Drug Administration.”

However, the FDA argued that Evers had misbranded the drug by advertising the off-label use.

Even though the FDA rarely takes enforcement action against physicians, because of its reluctance to interfere with the practice of medicine, the FDA has taken action against manufacturers and distributors, including large pharmaceutical companies, for promoting a drug for off-label use. This is an arena of regulatory peril.

One area of recent FDA concern is use of HCG for weight loss. The FDA requires that all labeling and advertising of HCG in a weight loss include a notice that: “HCG has not been demonstrated to be effective adjunctive therapy in the treatment of obesity. There is no substantial evidence that it increases weight loss beyond that resulting from caloric restriction, that it causes a more attractive or ‘normal’ distribution of fat, or that it decreases the hunger and discomfort associated with calorie-restricted diets.”

Concomitant with FDA concerns about off-label use with respect to prescription drugs are:

• FTC Advertising Issues
• State Law Issues
  • State Advertising Laws
  • Medical Board Discipline

The FTC in particular targets claims for weight loss products. State laws also prohibit false and deceptive advertising, and unfair competition. Manufacturers and distributors sometimes refer to use of a medical device for a purpose other than its FDA-cleared indication as “off-label”. Although “off-label use” more typically refers to prescription drugs, the concept has a parallel to the medical device arena.

Recently, one of our clients faced an enforcement investigation from the State Attorney General, based on advertising of a medical device (a laser) for a purpose other than its FDA indication. Our legal team has also testified before the California Chiropractic Board about chiropractic use of lasers for uses not cleared by the FDA in connection with these devices.

Whenever a drug or device is subject to FDA regulation, it is critical to seek legal counsel with respect to uses outside current FDA approval or clearance.

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