Dr. Toxin, a highly successful cosmetic dermatologist, has heard about an exciting new neuromodulator that is popular in South America, but has not yet undergone clinical trials for the U.S. Food and Drug Administration (FDA). Dr. Toxin traveled to South America and learns that it may be much less expensive than the currently available FDA-approved neurotoxins, and it may last longer. While he cannot use this product in his U.S. office, he discusses the product with the national press at the urging of his marketing department.
Dr. Toxin is excited about the growing number of companies studying and gaining FDA clearance for new neurotoxins. His growing publicity leads to an increase in cosmetic patients requesting appointments. A fellow dermatologist warns that his marketing may lead to the FDA “coming after him.” They are both aware that the FDA had contacted a well-known cosmetic dermatologist in the past about her exuberance in the press over a toxin that was undergoing FDA studies. Does the FDA have jurisdiction over Dr. Toxin?
The FDA receives its authorization under the Food, Drug and Cosmetic Act (FDCA). This regulation both governs 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 underlying purpose of the FDA is to be certain that drugs and devices are safe and effective; and, to ensure 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 the pharmaceutical industry. 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 on pharmaceutical companies and their physician executives, the FDA, as well as nearly all insurers, recognize that physician use of drugs and devices in an “off-label” manner is a benefit to patients.
In the end, the FDCA authorizes the FDA to regulate manufacturers’ activities. The FDCA does not authorize the FDA to regulate physician behavior. Having said that, as described above, the FDA can regulate physician executives who work for drug and device companies.
There are also other exceptions when the FDA can regulate physician behavior. In 2004 a drug scandal emerged when four people were temporarily paralyzed after receiving a botulinum toxin that was not approved for human use. The doctor in that case led investigators to a California-based company that sold large volumes of a research grade neurotoxin to TRI, a Tucson, Arizona-based company. This material was, in fact, approved for use in animals by veterinarians; it was not approved by the FDA for human use. The FDA shut down the facility and found a list of some 200 doctors who had used the material. The question raised at the time was whether the FDA had jurisdiction over these doctors.
The FDA does have jurisdiction over promotional comments by physician investigators of drugs even if that physician is not an executive of the pharmaceutical company. One of the FDA-related regulations (21CFR 312.7a) states that “a sponsor, investigator, or any person acting on behalf of the sponsor or investigator cannot promote a drug as safe and effective for the purpose for which it is under investigation.”
If Dr. Toxin had made his promotional comments about a drug that he was personally investigating during an FDA trial, the FDA could stop this behavior. Where Dr. Toxin was “promoting” a drug that was not at all available in the United States, the FDA is unlikely to assert its jurisdiction over him.