Off-Label Use of Medical Products: An Update of Sorts

Last December, in a 2-to-1 ruling, a federal appeals court in Manhattan, N.Y., vacated the criminal conviction of a pharmaceutical sales representative who was charged with promoting a drug for a use that was not approved by the FDA. In rendering its decision, the court noted the case did not involve an illegal use of a product and said that the plaintiff's actions were a form of constitutionally protected free speech, and was therefore not subject to criminal prosecution.

Art Kerley

While the ruling was widely hailed in the business press as a "landmark" decision with significant potential upside for drug and medical device manufacturers, industry press was less sanguine, and readily noted that the decision was unlikely to dissuade FDA from its vigilant efforts to pursue and prosecute firms that knowingly promote off-label use of their products.

Yet, in a move generally seen as surprising by industry analysts, the FDA announced in January that it would not challenge the ruling. (It should be noted that the jurisdiction of the particular court is limited to the states of New York, Connecticut, and Vermont.)

In the months following the decision, there has been a good deal of discussion in industry media and blogs about off-label use of medical products and situations that can create a liability issue for a manufacturer.

Many observers were reportedly surprised to learn there is nothing in the Food, Drug, and Cosmetic Act (FDCA) that expressly prohibits promotion of off-label use, and indeed, the FDA has recognized the fact that off-label use of medical products has advanced the art and science of medicine.

Off-label use of medical products is not an uncommon practice in either the United States or Europe. Estimates of such use vary widely, yet are largely unsubstantiated with scientifically obtained data. The incidence is believed to be far greater with pharmaceuticals, but devices are definitely in the mix as well.

Many jurisdictions in Europe require explicit informed consent of the patient before a drug or device can be used off-label. In the United States, physicians are generally free to use any FDA-approved drug or device for virtually any condition or procedure deemed to be within the good practice of medicine. There is no FDA regulation requiring patient notification and consent, but increasing numbers of hospitals and healthcare facilities are incorporating such a requirement into their standard operating procedures.

The FDA's concern regarding off-label use appears to be largely twofold. The first is essentially non-contentious and is the obvious need to prevent misleading and fraudulent claims from being promulgated for a medical product. The second is to prevent manufacturers from doing an end-run around the regulatory approval process.

Medical device manufacturers must obtain clearance -- typically through the PreMarket Approval (PMA) process with clinical trials -- for each use stipulated on the product's labeling. The agency acknowledges this can be a costly and time-consuming process and is concerned that off-label use, may, in fact constitute a "new product" that would require adherence to FDA's product approval procedures.

There seems to be an inherent conflict here. FDA acknowledges off-label use of medical products and further realizes that such practices may result in better healthcare outcomes assuming that such use is within the boundaries of sound medical practice.

The issue for the FDA is not the fact that off-label use exists, or even that it may be widespread. The issue is the promotion of off-label use. But while promotion is sometimes equated with the smarminess of the snake-oil salesman of old, is it not essentially the dissemination of information, which in the case of medical devices and pharmaceuticals could be in the best interest of advancing healthcare?

And what about that so-called landmark decision?

Law firms are advising their pharma and medtech clients to diligently maintain their regulatory compliance protocols and to stay abreast of all FDA alerts and guidance. Maybe the door has opened to a wider use of off-label promotion, but that may not necessarily be what manufacturers want.

What the general business press sometimes fails to realize is that manufacturers want clear and consistent regulatory standards because those standards are generally in the best interest of their business.

But arbitrary and capricious enforcement? Well, that's another matter.

In the age of the Internet and the ubiquity of social media, defining what constitutes "promotion" will likely set the stage for a very bumpy road going forward.

Buckle up and stay tuned.

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Art Kerley, President, The Fairfield Factor

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