Trust your instincts when a deal sounds too good
Editor's note: "The Higher Ground" is designed to keep ASPS members aware of the real-world ethical quandaries that plastic surgeons commonly face. The columnist, Joe Gryskiewicz, MD, Edina, Minn., has been practicing for more than 25 years, and he's a former member of the ASPS Judicial Council. Readers are encouraged to submit questions directly to Dr. Gryskiewicz at drjoe@tcplasticsurgery.com or to PSN@plasticsurgery.org. Names will be withheld, and the views expressed in this column are those of the author.Q: I just received a very brief fax today advertising for "Botox® 100 units: $475 with free overnight shipping with a minimum order of two vials... All product is Allergan - No Generics with Satisfaction Guaranteed. If you're not satisfied, we'll pay to send it back!" The ad listed a company name and toll-free number. I heard something years ago about botulinum toxin being marketed this way, and my understanding is that some of our members purchased and used this product - and were later prosecuted. The offer includes a good price compared to what I pay. What do you think I should do?
A: I think you should trust your instincts - and toss this advertisement with disdain. I received what sounds like the same fax and promptly called Allergan, which denied any attachment to this advertisement. The company told me this product is from a source outside the United States (OUS) and would not comply with FDA guidelines for marketing and distribution by stateside physicians. Vendors have used fax and Internet offers to try to convince medical professionals that the importation of these products is legal, but the importation of any pharmaceutical or biologic product into the United States from another country without FDA approval remains illegal - no matter how good the price.
You're correct in that a number of physicians - including ASPS members - got in hot water over this quandary a number of years ago. If you ordered this product and the FDA ever audited the source of this offer, it would find your name on that company's "purchaser" list. You could bet the FDA would pay you a visit and review your patient records. Please refer to this column in the October/November 2010 issue of PSN regarding the "Felonious filler," where I discuss FDA approval with respect to botulinum toxin A.
The FDA has clearly stated its views on the legal and clinical risks associated with such importation. According to the U.S. Federal Food, Drug and Cosmetic Act (FDCA), drugs that are imported are considered unapproved, misbranded and adulterated (21 U.S.C. 331). This includes foreign versions of FDA-approved medications, which have not been manufactured in accordance with and pursuant to an FDA approval. Patient health may be at risk as the identity, purity and source of the products are unknown. Biological products require strict manufacturing, storage and transportation procedures. Deviations in these processes may lead to degradation of clinical effect. The FDA recommends obtaining medicines exclusively from legal sources in the United States. Allergan and Allergan's authorized distributors are the only legal sources for Botox Cosmetic. For more information on this subject, visit fda.gov/Drugs/DrugSafety/ucm170594.htm.
Q: I injected Botox into a patient's platysma bands to improve her neck - I just saw this done at a recent meeting - but it didn't work at all. The patient is upset that she paid for no result, and she also brought up the fact that this treatment is not approved by the FDA. What do I tell her? Plastic surgeons and dermatologists are injecting Botox for all kinds of applications.
A: It's been said that "when all else fails, listen to your patients." First, the FDA does not "approve" anything. It's not like the "Good Housekeeping Seal of Approval." The agency clears medications and devices for "safety and efficacy" and "allows" them to be marketed and distributed for specific purposes. The FDA has cleared Botox for safety and efficacy - and allows it to be marketed, distributed and injected for aesthetic purposes (and for treatment of chronic migraines), but only in the glabellar area.
Other uses for facial aesthetics are considered "off-label," meaning the physician has chosen to use the product in a clinical application not described on the package labeling. This is common practice, as you know. However, I have a few questions for you: Did you explain to the patient that you would be using this product off-label before you injected her? Did you explain to her that off-label means the product is being used under the clinician's discretion and outside of the FDA guidelines and manufacturer's labeling? (I have an "off-label" macro that I discuss prior to injecting areas outside of the glabellar - I insert this macro into the medical record so I have documentation of our discussion. I verify and also document that the patient seems to understand this, and that all questions are elicited and answered.) Did you document an off-label discussion in your medical record?
If you answered "no" to any of these questions, you would be wise to tighten up your act in general, and specifically have an open discussion with the patient. What do you tell her? The truth. You might also consider giving her a "freebie" injection next time around - after a thorough discussion and documentation.
That said, I would like to make a distinction between off-label use, and using a product that is not already cleared by the FDA. Products used prior to FDA "approval" must be used under the auspices of an institutional review board (IRB) and/or an investigational device exemption (IDE). Advocating use of a product or device prior to "approval" can potentially land a physician in a very serious legal bind.
View the complete column in the September issue of PSN – available by clicking here.
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