Physicians and other professionals have the legal right to advertise under U.S. law, but when they do, their advertising is just as subject to federal consumer protections as any other advertiser. What you don't know about the laws designed to protect consumers could hurt you if your ads are questioned.

Federal laws prohibit unfair or deceptive acts or practices in advertising, and false advertising of food, drugs, and services. The responsibility for enforcement of these laws as they apply to drugs and medical devices is shared by the Federal Trade Commission and the Food and Drug Administration.

According to FTC official Matthew Daynard, advertising is considered "deceptive" if it is likely to mislead "reasonable" consumers and if it is likely to affect consumers' conduct or decisions. A practice is "unfair" if it causes or is likely to cause injury to consumers that they could not reasonably avoid and that is not outweighed by the benefits.

Daynard and A. Ralph Rosenthal, MD, director of the Ophthalmic Devices Division at the FDA, shared information about potential problems in refractive surgery advertising during a briefing at the American Academy of Ophthalmology meeting in Dallas in October.

It is not always easy to determine just what constitutes a promotional activity. Clearly, newspaper and radio ads are promotional, but what about signs in the waiting room or patient brochures? The key is to remember that the regulatory agencies have jurisdiction over business and advertising practices, not over the practice of medicine, and no one is out there snooping around doctors' offices. "Frankly, the agency has enough to do just getting through its PMA [pre-market approval] applications. I don't think the agency is going to go after anyone for something you are promoting within your practice," Rosenthal said.

In fact, the FDA rarely gets involved in matters of advertising by physicians or medical practices, focusing its efforts instead on advertising by the drug companies and device manufacturers. The agency is most likely to play a role when advertising mentions a specific device or drug name. It also has specific guidelines for advertising investigational and off-label uses of a device.

These distinctions get tricky, especially with excimer lasers. According to Rosenthal, the agency made a decision to treat each indication (myopia, hyperopia, astigmatism, and mixed astigmatism) separately when approving excimer lasers for the U.S. market. Therefore, using a laser approved for hyperopic photorefractive keratectomy for hyperopic laser in-situ keratomileusis is an off-label use of the device, while using a laser approved only for myopia to correct hyperopia is an illegal use of the device.

Physicians are not supposed to be promoting the off label procedure in either case, unless they are participating in a clinical trial under an investigational device exemption. In this case, physicians can advertise to obtain subjects for the clinical trial. In practice, there is not much oversight by the FDA of promotion of off-label uses by physicians, particularly if they have already become widely accepted as a standard of care.

The FTC, Daynard said, espouses three basic principles for all advertisers:

? Tell the truth. Don't mislead consumers about the benefits or safety of your product by what you say expressly or by what your ad implies.

? Tell all the truth. Don't omit information that is needed to keep what you say from being deceptive.

? Make sure it is the truth. Have adequate support for any objective claim, express or implied. This support must be competent and reliable scientific evidence, although it doesn't have to be a formal double-blind study. One study isn't much of a backup, however, if the weight of the evidence in other studies runs contrary to a claim.

The most frequent reason for running afoul of the FTC, Daynard said, is reliance on supporting evidence that isn't actually relevant to the claim being made. For example, an ad claiming "95% of patients achieve 20/40 or better" could be considered misleading if it's based on a published study of patients seen elsewhere, rather than your own patients, especially if the protocols or procedures used in your practice differ from those in the study.

The FTC also frequently sees advertising claims that exaggerate the degree or permanence of effect or mischaracterize the certainty of the science. It doesn't look favorably on fine print disclaimers.

When the FTC reviews an ad to determine whether it is deceptive or unfair, everything about the ad is taken into consideration - not just the wording. The agency looks at placement and relative size of disclaimers, visual images, and text to determine the net impression on a reasonable consumer.

Daynard offered a list of advertising fairness concerns related to refractive surgery that should give pause to just about anyone involved with refractive surgery advertising:

? Safety and efficacy claims with wording such as "Throw away your glasses," "Eliminate the need for glasses or contacts," and "Results are highly predictable" are suspect and require substantiating evidence.

? Even the oft-used phrase, "reduce or eliminate the need for eyewear" needs further qualification.

? Claims that a refractive procedure is painless may be difficult to substantiate.

? Consumer or celebrity testimonials can be considered misleading if they convey the impression that the consumer will have 20/20 vision like the person providing the testimonial.

? The term "laser vision correction" gives the consumer no inkling that surgery is involved.

? Comparative efficacy claims. Many ads now tout that their laser or diagnostic equipment is better than the competition's. Some claim a device is rated higher than others are, although the FDA doesn't rate devices comparatively.

? Lifetime guarantees. "The promise of a lifetime commitment in many LASIK ads probably overstates providers' ability to correct every postsurgical problem that arises over the long term," Daynard said.

When advertising consumer credit for refractive surgery, provisions of the Truth in Lending Act and other federal and state laws may require specific credit-related disclosures.

The bottom line? "Don't let your ad man write the ad in a vacuum," Daynard advised.

What exactly happens to physician or medical practice advertisers who can't substantiate their claims or otherwise engage in unfair advertising practices? Sometimes, nothing at all.

The FTC has put most of its emphasis on preventive efforts - working with national medical societies to get the word out about fair advertising practices. It recently published a patient brochure and web site called "Basik LASIK" that offers consumers information about LASIK and a guide for researching the procedure and discussing it with their doctors. The FDA is preparing to launch a comprehensive educational web site about LASIK, too, hoping that informed consumers would be less vulnerable to misleading ads.

But the FTC gets reports every day of "bad ads." It reviews these ads and can take one of several actions. Sometimes the case is referred to a state medical board or state attorney general for local action. Sometimes the physician is contacted informally and encouraged to pull or revise the ads. If warranted, the FTC sends a formal advisory letter outlining its concerns. Taking the physician to court for false or deceptive advertising is a last resort and has, so far, been rare.

Physicians in the same market initiate many of the cases the FTC investigates. "If your colleagues have a problem with it, the FTC will probably have a problem with it," Daynard said. Questionable ads can be sent to him. Practices can also ask for a review of ads before they run. Although the agency doesn't "approve" ads per se, Daynard will review ads upon request and tell the physician or practice what concerns he has with the proposed ad, if any.

Contact Information
Daynard: 202-326-3291, mdaynard@ftc.gov, www.ftc.gov/bcp/guides/guides.htm
Rosenthal: 301-594-2205, fax 301-480-4201, arr@cdrh.fda.gov