A Black Market for Botox?

Posted By American Med Spa Association, Saturday, September 8, 2012

By Renee Elise Coover
Not only can you buy a fake Louis Vuitton handbag for $20 (normally priced over $1000) or a counterfeit iphone from China, but now you can even score fake Botox—a deadly toxin–on the Black Market. Until now, Allergan, the only patented FDA-approved manufacturer of Botox in the United States, has successfully monopolized the market. Competition is on the rise as off-shore and web-based companies lure licensed physicians to purchase counterfeit Botox at bargain prices by fraudulently claiming the Botox brand name on labels.
As Botox increasingly becomes more popular, claiming to cure not only wrinkles and frown lines but even urinary incontinence and arthritis, the demand for this "miracle” drug is rapidly increasing. The demand continues to surge, and since there is no legitimate competitor, Allergan is able to use its monopoly power to increase the price.
As prices for this drug soar, illegitimate competition is surfacing – in the form of bootleg Botox. Physicians across the country are receiving mailers, emails and advertising materials from distributors claiming to sell Botox for much less than Allergan is charging and the question has become- are these products legal? Can physicians purchase Botox from off-shore distributors and how do they know if the distributor is selling "real” Botox or a counterfeit version?
According to the Food and Drug Administration (FDA), the United States Federal Food, Drug and Cosmetic Act prohibits the interstate shipment (including importation) of unapproved new drugs.[1] Thus, importing any drug that lacks FDA approval—whether for personal use or otherwise—violates the law.
How does one know if the distributor’s Botox is an unapproved drug? The FDA states that unapproved new drugs are "any drugs, including foreign-made versions of US-approved drugs, that have not been manufactured in accordance with and pursuant to FDA approval.”[2] Any medicine bought over the internet from foreign sources, from storefront businesses that offer to buy foreign medicine for the physician, or during trips outside the United States, may not be safe or effective because these medicines present health risks and their safety cannot be FDA ensured.
The distribution of this new bootleg Botox threatens to undermine the safe manufacture, sale and transport of a potentially dangerous – and even deadly – drug in the United States. Additionally, its distribution causes a huge risk malpractice for physicians. If a physician purchases bootleg Botox (knowingly or unknowingly), injects it into a patient, and the patient is injured because the product has been contaminated or damaged in shipment, it is likely the physician would be fully responsible.
The problem is not only affecting the U.S. market but is becoming widespread across the globe. Recently, in China, the public was warned by the Ministry of Public Security to ensure they are buying real Botox after it was discovered that a Chinese company was selling locally-made fake Botox.[3] The scam was actually discovered after Allergan complained that its name, but not its product was being used to sell Botox on an online shop in China.[4]
Buying fake Botox is clearly illegal since it is not FDA-approved, but many physicians still ask- what if I buy the real thing but I purchase the Botox from a company outside of the U.S- is that legal? The answer is no. It is true that Allergan sells Botox to pharmacies outside the U.S., particularly Canada, for a much reduced price. Of course, it is very enticing for physicians to buy the Botox on the cheap from a different country and ship it back to the U.S. However, the U.S. Drug Enforcement Administration (DEA) makes it illegal to import Botox or any other injectable from another country because the product cannot be properly monitored.Botox must be purchased directly from Allergan in the US where the FDA maintains safety levels not so strictly adhered to in other countries. Importation of cosmetic injectables like Botox from outside of the US can be a felony, subject to one year in prison and $100,000 in fines.[5]
So as the instance of counterfeit and imported Botox escalates, physicians and other purchasers of this popular drug must take extra care to check their sources and avoid the allure of buying Botox outside the U.S. on the cheap - because the results could be very expensive indeed.
Renee Elise Coover <rcoover@thierschlaw.com> practices with Thiersch & Associates in Chicago, Illinois. Thiersch & Associates specializes in med spa law. For more information contact Thiersch & Associates, 180 N. LaSalle St., Suite 3700, Chicago, Illinois 60601, (312) 981-0990, Thiersch@thierschlaw.com.