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  • Advertising Your Refractive Practice

    Of particular concern to the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) are advertising claims about devices approved for other purposes and potentially false and misleading information about refractive procedures.

    The Federal Trade Commission has primary jurisdiction over advertising of health care services, OTC drugs and devices. The Food and Drug Administration has jurisdiction over manufacturer product labeling and advertising, including prescription drugs. One issue of current interest concerns the advertising of “off-label” surgical applications, using an FDA-approved device (e.g., LASIK if laser is approved for PRK for a specific indication or, PRK if LASIK is approved for a specific device for a specific indication). The decision to use the excimer laser outside the scope of the approved labeling is considered, by the FDA, to be a “practice-of-medicine” issue; that is, the FDA recognizes that physicians are permitted by professional license to use an approved drug or device for another use that they believe is appropriate for diagnostic or treatment purposes. Physicians should be aware, however, that advertising of off-label use to patients is prohibited, and is not protected under the "practice-of-medicine" rubric. It is to your benefit, and that of your patients, to become knowledgeable about appropriate communications to the public.

    Rule 13 of the Code of Ethics (printed in full below) governs communications to the public regardless of their nature, format, or medium and regardless of whether or not they are overtly commercial. It must be stressed that the rule does not ban or discourage any particular format or type of communication provided that the content is not objectionable under the rule.

    Provisions of Rule 13:

    1. The first provision is that information provided by ophthalmologists be accurate.

    2. The second provision requires that, in their communications to the public, ophthalmologists avoid not only statements that are demonstrably "false" or "untrue" but also statements or ancillary communications (such as photos) that are "deceptive" or "misleading."

    3. The third provision is that ophthalmologists' communications to the public must not "appeal to an individual's anxiety in an excessive or unfair way."

    4. The fourth provision is that ophthalmologists' communications to the public should not "create unjustified expectations of results."

    5. The fifth provision expands on the foregoing point. If an ophthalmologist cites the benefits of particular ophthalmic procedures that also present significant associated risks, the ophthalmologist should simultaneously provide "realistic assessments" of the risks and availability of alternatives.

    6. The sixth provision is a specific one: an ophthalmologist must never misrepresent his "credentials, training, experience, or ability." Also, the ophthalmologist must not make "material claims of superiority that cannot be substantiated."

    7. The seventh provision requires that ophthalmologists clarify when they have paid in any way for public communications. Payment means anything of significant value, including provision of goods or services without the usual compensation.

    Rule 13 of the code of Ethics: Communications to the Public. Communications to the public must be accurate. They must not convey false, untrue, deceptive, or misleading information through statements, testimonials, photographs, graphics or other means. They must not omit material information without which the communications would be deceptive. Communications must not appeal to an individual's anxiety in an excessive or unfair way; and they must not create unjustified expectations of results. If communications refer to benefits or other attributes of ophthalmic procedures that involve significant risks, realistic assessments of their safety and efficacy must also be included, as well as the availability of alternatives and, where necessary to avoid deception, descriptions and/or assessments of the benefits or other attributes of those alternatives. Communications must not misrepresent an ophthalmologist's credentials, training, experience or ability, and must not contain material claims of superiority that cannot be substantiated. If a communication results from payment by an ophthalmologist, this must be disclosed unless the nature, format or medium makes it apparent.

    Advertising by ophthalmologists to patients, the public, the media, or other colleagues must be accurate. It is unethical to intentionally deceive. It is also unethical to decrease patients’ autonomy by withholding information, by shading it so that it is inaccurate in any way, or by presenting material in a way that prevents patients from making a truly informed choice. Inaccurate, false, or misleading advertising statements are unethical and will compromise the integrity of the physician and the profession.