To reduce costs, many physicians and medical spa owners commonly purchase dermal fillers, botulinum toxin and other cosmetic injectables from sources outside the United States. However, what many practitioners and medical spa owners may not know is that the practice of importing prescription products is illegal. Even though a prescription drug is approved by the U.S. Food and Drug Administration (FDA), the same drug is considered unapproved when it is illegally imported.
Prices for prescription drugs outside the United States are lower mostly because of government price controls and foreign distributors who make purchasing easy through Internet offerings with alluring prices and, often, a guarantee to beat any price. One might assume that since the Internet sites offering these products are public, it must be legal, right? But not so – there is almost always a disclaimer on the site. For example, “Importation and compliance with your local laws and regulatory authorities are solely your responsibility.”
Many suppliers outside of the United States also make claims to the unsuspecting physician or medical spa owner that the products are the same and “the only difference is the cosmetic appearance of the packaging.” In fact, when the prescription arrives, it may very well appear to be the same as the U.S.-approved prescription drug. Sellers may also claim that the prescription is exactly the same as its U.S. counterpart.
In fact, one site, Medica Depot, states: “as multinational manufacturers are required to package their products according to the distribution country’s requirements, there may be slight packaging differences. In several cases, some products are manufactured overseas as the major patent holder for that product may provide marketing rights to different companies in specific jurisdictions. For example, RESTYLANE® is exclusively marketed by illegal importation against the purchaser and seller of Medicis in North America, and it is marketed exclusively in Europe by Q-Med AB. In most instances these products are manufactured in the exact same manufacturing facility that is approved by multiple regulatory authorities such as the FDA, Health Canada, and/or others as well. Of course if you are located in the jurisdiction from which the product you are ordering originates, then obviously you will receive the exact same product available through local distributors in your jurisdiction.” (www.medicadepot.com).
But don’t be fooled by this type of claim. Without FDA approval, there is no way to ensure the safety and effectiveness of the drug. For that reason, the sale or purchase of any imported prescription drug is illegal.
What’s the big deal? The FDA is concerned about drug imports because it has no way of overseeing the safety of the drugs. “Consumers are exposed to a number of potential risks when they purchase drugs from foreign sources or from sources that are not operated by pharmacies properly licensed under state pharmacy laws. These outlets may dispense expired, subpotent, contaminated or counterfeit product, the wrong or a contraindicated product, an incorrect dose, or medication unaccompanied by adequate directions for use.” (www.fda.gov).
If something does go wrong with the product and a patient suffers an injury, the patient and physician may have no recourse against the manufacturer or distributor because the manufacturer or distributor is outside U.S. jurisdiction. .
Because of the potential risk to consumers, the FDA has increased its efforts in prosecuting cases of the imported product. In fact, the FDA’s Inspections, Compliance, Enforcement, and Criminal Investigations division reported 39 cases in 2014 alone, many of which were prosecuted against physicians and spa owners.
In a case reported on May 7, 2014, the physician/owner and office manager of an esthetic and skin care clinic in Virginia were convicted on charges of illegal importation, receiving and delivering non-FDA-approved drugs and devices, and engaging in the unlicensed wholesale distribution of prescription drugs. According to court records and evidence at trial, the owners partnered with Gallant Pharma, an unlicensed wholesale prescription drug distributor, in exchange for a deeply discounted price on non-FDA-approved cosmetic drugs and devices.
The illegally imported cosmetic drugs and devices were used on patients at the physician’s Virginia practice and another clinic without the patients’ knowledge or consent. The physician/owner faces a total maximum sentence of 87 years in prison.
The FDA has no intention of backing down from its investigations. Until there is legislation permitting the importation of prescription drugs – don’t do it. The potential savings from purchasing imported prescription drugs is not worth the risk. Only purchase prescription drugs from reputable U.S. pharmaceutical manufacturers.