FDA warns against purchasing pharmaceuticals from foreign or unlicensed suppliers

Thursday, November 21, 2013 11:08 AM
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Over the course of the last few months, the FDA has sent notices to physicians across the country, including Colorado, warning them about the illegality of purchasing pharmaceuticals from foreign or unlicensed suppliers, some of whom even have detailers and all the collateral materials to create the illusion of legality and respectability.

Physicians who purchase from these unlicensed and foreign sources not only trigger an FDA investigation, they also draw the attention of the state medical and pharmacy boards since those purchases of illegally imported drugs also violate state statutes governing pharmaceuticals and medical practice.

FDA approvals are manufacturer and product specific and include an array of requirements regarding manufacturing location, formulation, source specifications of active ingredients, processing methods, container-closure systems and appearance. A product imported into the United States that is unapproved for U.S. sale or does not comply with U.S. labeling requirements is prohibited according to federal law. Many states have comparable statutes to the FDA.

Even if drugs sold outside of the U.S. are manufactured by the same company that makes the product for the U.S. market, the version produced for foreign markets is typically not branded for sale in the United States since the foreign version lacks information required by federal law. These drugs are often labeled in a foreign language, making it difficult for patients to understand the risks associated with its use.  Many drugs contain medication guides or directions for patient use that should be read prior to the patient receiving the product. If the product is imported or of unknown origin, the patient is far less likely to have information critical to their care.

It is also fraudulent for prescribers who prescribe, dispense, or administer illegally imported drugs to file for reimbursement. Moreover, if the product caused any injury, the prescriber could be exposed to malpractice liability without support from the manufacturer. To compound those infractions, the sale of misbranded and mislabeled drugs could trigger unfair and deceptive business practice claims under federal and state law, which carries a treble damages penalty.

The health risks are self-evident: Those products are often of unknown origin, dubious quality and improperly labeled. There are no assurances that the product has been stored properly, which can be hypersensitive to temperature fluctuations and other environmental conditions. There is also no assurance the product isn’t counterfeit or that it actually contains the appropriate active ingredient; products of unknown origin could contain toxic or inactive ingredients.

Like street knockoffs of high-end watches, handbags, or jewelry, physicians should intuitively know that with that kind of pricing, there’s a high probability it’s not the real thing. And there is a higher price to pay when the knock off is a non-FDA approved
prescription drug. 

Physicians getting solicited to purchase drugs can readily verify their legality through the FDA website: www.fda.gov/Drugs/DrugSafety/ucm170594.htm as well as the state board of pharmacy: http://cdn.colorado.gov/cs/Satellite/DORA-Reg/CBON/DORA/1251632324357

Posted in: ASAP | Practice Management | Legal and Ethics


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