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Does FDA have jurisdiction over physicians' promotional efforts?


Dr. Buttox travels to Europe to learn about a new botulinum toxin that is popular there. He understands he can't use the product in his office without FDA approval, but his marketing department gets him to discuss the product with the national press. Does the FDA have jurisdiction over Dr. Buttox in this instance, and if so, to what extent?

Key Points

Dr. Buttox goes to Europe to learn how to use the product and finds that it may be much less expensive than the currently available FDA-approved botulinum toxins - and it may last longer. Dr. Buttox understands that he cannot use this product in his office without FDA approval, but his marketing department gets him to discuss this product with the national press.

It isn't long before Dr. Buttox receives great publicity over this, which leads to a large number of cosmetic patients coming into his office. A fellow dermatologist warns him to stop the advertising because such marketing may lead to the FDA "coming after him"; after all, both physicians are aware that a well-known cosmetic dermatologist heard from the FDA about her exuberance in the press about another toxin that was undergoing FDA studies.

FDA oversight

The FDA receives its authorization under the Food, Drug and Cosmetic Act (FDCA), which governs the interstate distribution of medical products and mandates that both drugs and devices must, through evidence-based studies, be shown to be safe and effective for their on-label purpose.

The FDA is charged with ascertaining that drugs and devices are safe and effective, and ensuring that drug/device promotion is not false and/or misleading. The FDA does this through a variety of methods that directly impact pharmaceutical companies.

Included in this oversight is the FDA's regulation of promotional programs sponsored by pharmaceutical companies. In fact, in such programs, physician executives who speak on behalf of a pharmaceutical company must provide fair balance, stay "on label" and be truthful.

Despite these regulations for pharmaceutical companies and their physician executives, the FDA (as do almost all insurers) also recognizes that physician use of drugs/devices in an "off-label" manner is of benefit to patients.

In the end, the FDCA authorizes the FDA to regulate manufacturers' activities. The FDCA does not authorize the FDA to regulate physicians' behavior. Still, as described above, the FDA can regulate physician executives who work for drug/device companies.

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