In their article “Importing Injectables” in the September 2014 issue of the Journal of Drugs in Dermatology, Dr. Kenneth Beer and Karen Rothschild highlighted the possible harm to patients and practitioners from the use of unapproved botulinum toxin products – eg, Botox, Dysport, Xeomin, and Myobloc – and other cosmetic prescription drug products purchased from foreign or unlicensed suppliers.1 In the intervening years, the accuracy of their critique has been repeatedly demonstrated, as the dangers to patients’ health, as well as to cosmetic practitioners’ liberty, has only increased.Not surprisingly, given the countries from which the unapproved cosmetic products are frequently sourced, a significant percentage are counterfeit and/or misbranded or adulterated and their use is a violation of federal law, possibly subjecting the practitioner to criminal sanctions, fines, loss of a medical license, and malpractice liability. More importantly, the use of these products puts patients at risk and, for this reason alone, the FDA’s Office of Criminal Investigations (“OCI”) is actively seeking to identify, warn, and, in some cases, prosecute practitioners who purchase or administer counterfeit and/or misbranded or adulterated drugs that have been illegally imported into the United States.The significant dangers posed by the importation of unapproved drug products have also recently caught Congress’ attention. Just last month (August of 2017), Congress passed (and the President has pledged to sign) legislation that significantly increases the penalties associated with illegally imported drug products. As a result of these revisions to the Food, Drug & Cosmetic Act (“FD&C Act”), healthcare practitioners who knowingly make, sell, or dispense (or hold for sale or dispensing) illegally imported botulinum toxin drug products may now be imprisoned for up to ten years and fined up to $250,000. Under federal law, healthcare practitioners may also be subject to forfeiture (of property) and disgorgement (of past revenues) for selling and dispensing illegally imported botulinum toxin drug products.Real Criminal of Orange CountyBridget “Gigi” Goddard, the owner of a skin rejuvenation practice in Southern California, was outwardly extremely successful. Her medical spa’s clients included stars of the hit TV show “Real Housewives of Orange County” and she even appeared on the cover of a local magazine. What her clients didn’t know, however, is that she was risking their health by purchasing (and then injecting them with) unapproved botulinum toxin products from overseas internet sellers.On November 10, 2016, the U.S. Attorney for the Central District of California announced that Goddard had agreed to plead guilty to a federal charge – receipt and delivery of a misbranded drug – which carries a penalty of up to three years in prison. According to the United States Department of Justice, Goddard was caught knowingly misleading an FDA undercover agent as to whether the botulinum toxin that she offered to inject into the FDA agent was approved for use in the United States. In the guilty plea announcement, the Special Agent in Charge of the FDA’s Office of Criminal Investigations said, “When criminals attempt to distribute unapproved drugs in the U.S. marketplace, they put the public’s health at risk. Our office will continue to pursue and bring to justice those who would jeopardize the health and safety of the public.”Siren Song of the Internet SellersGoddard admitted that, over the course of several years, she ordered Botox over the internet from Canadian companies that specialized in selling unapproved drugs to customers in the United States. Until late 2014, she purchased from Toronto-based S.B. Medical, Inc., Botox manufactured for distribution in Turkey and other countries. In early 2015, after S.B. Medical ceased operations because of an FDA criminal investigation, Goddard began purchasing Botox from Doctor Medica based in Vancouver, Canada, and from at least one other internet seller. The Botox from Doctor Medica was manufactured for distribution in Europe and was shipped from Great Britain.Since it is specifically named in Goddard’s plea agreement, Doctor Medica is clearly operating on borrowed time. Yet, as of early March 2017, the company’s website was still offering “healthcare professionals worldwide” dozens of “brand name medical injectables to alleviate osteoarthritis symptoms, reduce signs of aging, and enhance beauty,” including botulinum toxin products. Doctor Medica is even so brazen as to offer a referral fee to doctors – a $400 account credit when the referred doctor’s orders reach $1,750.Another internet seller, Amazon Medica, offers low prices for brand name botulinums, dermal fillers and orthopaedics. The company falsely implies that its drugs are approved for use in the United States, touting that “Every vial and box of product delivered to the U.S. travels through FDA-monitored customs channels to ensure both regulatory compliance and the most efficient delivery times for our physician clients.” Amazon
Cosmetic Practitioners Take Huge Risks Purchasing and Administering Illegal Botulinum Toxin Drug Products
September 2017 | Volume 16 | Issue 9 | Editorials | 936 | Copyright © September 2017
Sheldon Bradshaw JD
FDA and Life Sciences Practice Group, King & Spalding,Washington, DC
AbstractIn their article â€œImporting Injectablesâ€ in the September 2014 issue of the Journal of Drugs in Dermatology, Dr. Kenneth Beer and Karen Rothschild highlighted the possible harm to patients and practitioners from the use of unapproved botulinum toxin products â€“ eg, Botox, Dysport, Xeomin, and Myobloc â€“ and other cosmetic prescription drug products purchased from foreign or unlicensed suppliers.1 In the intervening years, the accuracy of their critique has been repeatedly demonstrated, as the dangers to patientsâ€™ health, as well as to cosmetic practitionersâ€™ liberty, has only increased.