News, Views & Reviews: Importing Injectables

ads, coupons, and other enticements to get treated with “Botox” at far lower prices than are available for the approved product.

How do you patients find these often-fraudulent offers? The answer is that the offers frequently find them! The ads are ubiquitous; appearing in web advertisements, coupon offerings, magazine ads, even bus kiosks. They are so common, that patients assume they are legitimate. Additionally, there are still unscrupulous practitioners who misrepresent fake products to patients, leading them to believe that they are receiving real Botox ^® Cosmetic. Charlatans may place advertisements, and may display false certificates indicating that they received training from the Botox^® manufacturer, from the American Academy of Dermatology or The American Society of Plastic Surgery when they have not. These scammers not only violate the objective of the Hippocratic Oath and intentionally put their patients in harms way, but they have sullied the reputation of legitimate, honest, and well-trained cosmetic practitioners.

An increasingly alarming trend has been identified as suppliers of false cosmetic injectables scam doctors who look to Canada or Europe for cheaper alternatives; however, there is no easy way to verify that the products are originating from the advertised country. These cosmetic practitioners may be injecting patients with fraudulent products. Sometimes these cosmetic practitioners may feel compelled to look for lower-cost products due to the insistence on discounts by patients. Unscrupulous suppliers are well aware of this pricing pressure and have responded with cheap, fraudulent material. They provide assurances that their “Botox” product or other drugs are US-equivalents, or are products approved in other countries. What they don’t want you to know is that even if they were using the actual products described, simply importing or causing the importation of unapproved drugs when there is an FDA-approved drug available is illegal in addition to being dangerous. Furthermore, even if a product is approved in another country, the fact that it is being sold by a supplier that is outside of the regulated drug supply chain means that there are no assurances that the product was stored or handled under proper conditions on its way to the US Just because an unlicensed and/or foreign supplier says what the product is, there is no way to know for sure. In the US legitimate supply chain, to be authorized to store, handle and distribute prescription drugs, wholesale drug distributors must be licensed in each state in which they do business.

FDA alerted healthcare practitioners and the public in April and July of 2013 that fraudulent versions of Botox^® are being sold to medical practices by unlicensed suppliers who are not part of the legitimate U.S. supply chain. FDA sent doctors, clinics, medical practices and spas letters alerting them to the dangers of buying unapproved or counterfeit products, and specifically alerting them about the fraudulent versions of “Botox”. Under federal law, no form of botulinum toxin may be commercially distributed for use on humans in the US unless it has been approved by FDA. At this time, Botox^® and Botox^® Cosmetic (made by Allergan Inc), Xeomin^® (made by Merz) and Dysport^® (made by Ipsen Biopharm) are the only Type A botulinum toxins approved by FDA.

Counterfeiters have become good at making fake copies of packaging and product, and it may be difficult to tell the fake from the legitimate just by looking. An example of the subtle difference between the FDA-approved Botox^® for injection (100 units/vial), manufactured by Allegan, and a known illegal version, is that Allergan’s Botox^® is labeled as “OnabotulinumtoxinA”, while the illegal version is labeled as “Botulinum Toxin Type A”. While a fraudulent version of a drug may purport to have the same active ingredient as the FDA-approved product, one cannot be sure what it actually contains. The fraudulent version is not legally marketed and has not been established by FDA to be therapeutically equivalent to or interchangeable with any US approved product. It is important to remember that if it has not been approved by FDA, and is not bought within the legitimate supply chain, there is no telling what you or your patients might be getting.

There are several ways in which you can protect yourself, your patients, and your practice. First, always know whom you are buying your medications from. Assure that you either purchase medications directly from the manufacturer of the FDA-approved drug, from an authorized distributor for the manufacturer, or from a wholesale drug distributor properly licensed in the United States. You can check to see if the distributor holds a current license before placing an order. Most states have this information online on their website.a Be wary if the price of a medication sounds too good to be true. Deep discounts may be offered because the product is stolen, expired, counterfeit, unapproved, or otherwise substandard. Also, carefully inspect all product and packaging. The following signs may indicate that the product is not FDA-approved or otherwise does not meet US regulatory requirements:

The medication has a different brand name than what was ordered.

The packaging or label looks different from the product you usually receive.

Portions, or all, of the labeling are not in English – when you have previously seen the labels in English only.

Shipping addresses, postmarks, or other materials indicate that the package came from outside of the US.

The labeling does not state “Rx only” even though the product is restricted to prescription use in the US.

The dosing recommendations are unfamiliar.

The dosage form or route of administration is different than what you usually receive (eg, ampule instead of prefilled syringe).