Are your practice's marketing and advertising initiatives, including those on social media, compliant with FDA and FTC regulations?
By: Jolynn Cook, RN, COE, CASC
Ophthalmic Professional March 1, 2014Vol 3, Issue March 2014Page(s): 32, 35
Compliance
Keep Advertising Above Board
Are your practice’s marketing and advertising initiatives, including those on social media, compliant with FDA and FTC regulations?
By Jolynn Cook, RN, COE, CASC
Six years ago, the leading professional organizations for ophthalmology (AAO, ASCRS and ISRS) published a Policy Statement to assist ophthalmologists with advertising refractive surgery. Spring is the perfect time to take a break from your schedule to review how your practice is advertising LASIK and refractive cataract procedures.
A practice’s responsibility
Keep in mind physicians and other advertisers are legally responsible for the truth and accuracy of their advertising, even if it is prepared by an ad agency. Patients seeking refractive surgery have a wide variety of needs and expectations and, more likely than not, surgical outcomes will vary significantly. Protecting the integrity of your advertising is critical, as legal challenges often arise when patient expectations are not met. Information provided by your practice must be truthful and accurate.
Defining advertising
The Policy Statement provides a definition of advertising. Typically, we think of TV ads, radio and newspaper and the printed brochures, videos or other material given to our patients. However, the Federal Trade Commission Act will likely include Internet ads and social media as advertising. The physician has a responsibility to adequately inform patients about treatment options and alternatives. It is important to understand and take into consideration that both the FDA and the FTC have jurisdiction with regard to advertising material.
Established Advertising Protocol Checklist
The following checklist is for quick reference to assure your advertising is compliant with established protocol for refractive surgery advertising:
■ Published information provides truthful, informative advertising of refractive surgery.
■ Published information is clear and not confusing or misleading to the consumer.
■ Information is not deceptive, missing or deleted.
■ Advertising is literally true and does not convey a misleading impression to a reasonable consumer.
■ Advertising claims made must have a reasonable basis and the practice must be able to substantiate claims made in advertisement.
■ Advertising may not contradict disclosures of risk.
■ Informed consent forms will not compensate, legally or ethically, for misleading statements made in advertising.
■ Patient testimonials are substantiated by reliable scientific evidence. Note: check state laws regarding use of testimonials in advertising as this may vary state to state.
■ Avoid promising a “lifetime commitment” to correct every post-surgical problem.
Regulators are watching
According to information in the Policy Statement, the Federal Trade Commission Act prohibits false and deceptive advertising, as do similar state laws. The Federal Food, Drug and Cosmetic Act also prohibits false and misleading advertisements for restricted medical devices, including FDA approved lasers for cataract and LASIK surgery. Advertising that is literally true, but that conveys a misleading impression to reasonable consumers may be unlawful.
The FTC has primary jurisdiction over advertising of health care services, over-the-counter drugs, and devices. The FDA has jurisdiction over product labeling for prescription drugs and medical devices.
Advertising Phrases to Avoid
Marketing material and advertising should always avoid certain terms that may have different meanings to different consumers. This is a list of just a few of phrases to avoid:
■ “_______ laser is ranked highest by the FDA”
■ “We use _______ laser so that you get the best results”
■ “Our surgeons are more experienced than any of their colleagues in (state/region)”
■ “LASIK is the safe and easy alternative to glasses!”
■ “Throw away your glasses!”
■ “See naturally with LASIK surgery”
■ “Permanent correction”
■ “LASIK is a safe and painless procedure’
Regardless of the information disseminated through your advertising, honesty, truthfulness and transparency are paramount to keeping your practice compliant. OP
Ms. Cook is the Administrator of the Laurel Eye Clinic and the Laurel Laser & Surgery Centers. A Certified Ophthalmic Executive and Certified Administrator Surgery Center, she is a registered nurse and also has a degree in Health Care Administration.
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