Question: My partner suggests purchasing a Botox-like medication from another country because we can obtain it for much less than the U.S. counterpart. The literature on this medication indicates it has a proven history as a therapeutic agent. The plan is to call this medication “Botox” in our practice to avoid confusing our patients. We haven’t yet worked out the billing details yet. I am concerned about the legal aspects of this plan, but my partner argues that Botox use in ophthalmology is considered “off-label,” and this is just another form of “off-label” use. Would this scenario violate any laws or the Academy Code of Ethics?
Answer: Yes, it would violate federal law, some state laws, and the AAO Code of Ethics. The use of “Botox-like” medications would not only be considered off-label but also illegal. To ensure safety and effectiveness, the FDA regulates drugs and medical devices used in the United States. It does not regulate how drugs are used, so your partner is correct in stating that Botox is used by U.S. ophthalmologists for off-label purposes. However, Botox is an FDA-approved medication, whereas the “Botox-like” medication from overseas is not. Importing it, using it in a clinical setting, and calling it “Botox” is known as misbranding. Section 502 of the Federal Food, Drug and Cosmetic Act addresses misbranding, which is defined as false or misleading labeling. Billing for use of misbranded medication is health care fraud.
The scenario would also raise ethical concerns involving Rules 2, 6, 9, 10, and 15 of the Academy’s Code of Ethics. Using a misbranded drug would violate Rule 2, Informed Consent, because the patient would be given false, deceptive or misleading information and could not appropriately be apprised of the risks of the medication’s use. Without full knowledge of the medication’s effects, you could not appropriately recommend treatment with it after careful consideration of the patients physical, social, emotional, and occupational needs, per Rule 6, Pretreatment Assessment. Furthermore, Rules 9 and 10 would be involved because you would be misrepresenting the medication to the patient and potentially utilizing it in a manner not in the patient’s best interests. Lastly, Rule 15, Conflict of Interest, would be involved, as the patient’s well-being would be clearly influenced by your financial interests.
Learn more at aao.org/clinical-education/redmond-ethics-center.
To submit a question, contact the Ethics Committee at ethics@aao.org.