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Read the Label Carefully: How Advertisements for “Off-label” Drugs or Devices Could Harm Your Practice
When legal action is initiated against your practice alleging medical malpractice, plaintiff attorneys often carefully review your advertisements, radio and television commercials, web site and social media pages, marketing brochures, and patient education documents looking for inaccurate, unsubstantiated, or misleading information. Problematic statements in your advertisements, if relevant to the case, could sway potential jurors in favor of the plaintiff and require settlement of a claim even if your care was otherwise defensible.
Marketing for both refractive surgery and “off-label” usage of ophthalmic drugs or devices have been in the news recently after the FDA released a September 2011 statement highlighting increased scrutiny for advertising by ophthalmic practices. Because your marketing activities may carry significant legal and ethical risks for your practice, OMIC strongly recommends careful review of your marketing campaigns to ensure that all materials comply with FDA (and other regulatory and professional) requirements.
If a drug or device has been approved by the FDA for a specific use or medical procedure and subsequently is used “off-label” for a different procedure (regardless of how common the off-label usage becomes) the advertisement of the off-label use of an identified drug or device may not be allowed. Physicians should also not claim a drug or device is “FDA approved” when it is being used for an off label procedure that is different from the actual procedure for which the approval was originally granted.
Because ophthalmologists who publish misleading marketing materials may face increased professional liability exposure, your malpractice carrier may be unable to maintain coverage if advertisements fall substantially outside of required regulatory or ethical guidelines. You could also face lawsuits from other ophthalmic practices for “unfair trade” resulting from inaccurate or fraudulent advertisements or face ethics investigations by professional and medical societies.
See risk management tips below, including a list of resources that may help you identify and avoid increased exposures from your advertisements. Because of the prevalence of refractive surgery and off-label drug and device advertising, some resources are specifically related to those topics, however there are also general advertising guidelines and requirements that pertain to any ophthalmic practice. It is strongly encouraged that you instruct your marketing consultants to comply with all applicable regulatory and advertising restrictions.
Risk Management Tips:
- Do not advertise “off label” uses for identified drugs or devices.
- Avoid statements that cannot be substantiated. Claims or statistics must have reference or supporting documentation.
- Refrain from subjective words or phrases such as “safe” “painless” or “results guaranteed.”
- Don’t exaggerate your skills, experience, or educational background.
- Avoid marketing “gimmicks” such as raffles, contests, free or donated procedures.
- Do not misrepresent patient or physician testimonials.
Related Resources:
American Academy of Ophthalmology (AAO):
Advertising Claims Containing Certain Potentially Misleading Phrases
Guidelines for Refractive Surgery Advertising
“Truth in Advertising” Legislative Actions
Federal Trade Commission (FTC):
FTC Staff Guides on Refractive Eye Surgery
Food and Drug Administration (FDA):
FDA Letter to Eye Care Professionals (September 23, 2011)
Truthful Prescription Drug Advertising and Promotion (Bad Ad Program)
FDA Statement on “Off-Label” Use of Marketed Drugs
American Society of Cataract and Refractive Surgery (ASCRS):
ASCRS and AAO LASIK Advertising Policy Revised
OMIC Risk Management Recommendation (RMR) guides:
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