So far this year, the agency has released more than a dozen guidance documents related to the development of new drugs, the use of pharmacogenomic data in drug submissions, quality considerations for cannabis-derived compounds and clinical trials for drug and biologics.
Here, we summarize the guidance on suspicious and illegitimate products, clarifying the interpretation of terms such as counterfeit, diverted, stolen, fraudulent transaction and unfit for distribution, as defined in section 581 of the FD&C Act (21 U.S.C. 360eee).
The FDA describes a counterfeit medication as having packaging, labeling or other identifying features, such as trademarks or trade names, that falsely suggest it was produced or distributed by a specific manufacturer, processor, packer or distributor. In reality, these counterfeit medications are not made or distributed by the claimed parties.
Counterfeiting is a widespread problem. In a 2021 incident, a pair of California-based cancer specialists pleaded guilty in a case related to procuring unauthorized and fake cancer treatments worth more than $1 million from a firm owned by a businessman in Winnipeg. IN the same year, the DEA carried out an extensive two-month operation, resulting in 810 arrests and the confiscation of over 1.8 million counterfeit pills containing fentanyl. The total number of counterfeit pills seized this year exceeded 9.5 million, surpassing the combined amounts from the previous two years.
Diverted products have either intentionally or unintentionally diverted from their intended distribution channels. In its guidance document, FDA noted that an example of a diverted drug is one that is reintroduced to the supply chain “after it was dispensed to a patient or otherwise removed from the U.S. pharmaceutical distribution supply chain.” Another example is a drug labeled for sale in a non-U.S. market that is brought into the U.S. pharmaceutical distribution supply chain.
One prominent example of a diverted drug dates back to 2012, when the FDA posted a warning about counterfeit versions of Genentech’s oncology drug Avastin (bevacizumab). The bogus version of the drug was labeled as Avastin, but had a Roche logo on the packaging. (Roche acquired Genentech in 2009.) The FDA-approved legitimate version, conversely, had a Genentech logo on the packaging.
After identifying these counterfeit drugs in the U.S., regulators verified that it did not contain the active ingredient bevacizumab, posing a risk to patients relying on the medication. The agency traced the drugs to a foreign supply chain, noting that criminals had diverted them through various channels before they entered the legitimate U.S. pharmaceutical supply chain.
Stolen products are those taken without permission or have missing portions due to theft. Stolen products can include the entire product and its packaging, only the packaging, only the prescription drug, or any prescription drug or its packaging that is missing all or any portion of the drug as a result of theft.
One notable example of pharma theft dates back to 2010 when burglars broke into an Eli Lilly warehouse in Enfield, Connecticut. The perpetrators made off with approximately $60 million in prescription medications, including antidepressants, antipsychotics and various other drugs. Authorities eventually discovered the stolen pharmaceuticals in a Florida storage unit in 2012 and apprehended the criminals. This case is likely one of the largest pharmaceutical heists in U.S. history. It highlighted concerns surrounding the security of pharmaceutical supply chains and potential public health risks from stolen drugs reentering the market.
Fraudulent transactions involve knowingly falsified information in transaction details, transaction history, or transaction statements provided or received by a trading partner. It may not be immediately evident whether product tracing information is knowingly falsified. Trading partners should take steps to determine whether errors can be resolved and whether the product is suspect or illegitimate.
Unfit for Distribution
Unfit for distribution refers to non-saleable products violating the FD&C Act that are likely to result in serious adverse health consequences or death. Examples include adulterated or misbranded products. FDA recommends the industry use existing policies and procedures to determine whether products are suspect or illegitimate.
A notable example of a product that was unfit for distribution is Baxter International’s heparin 2009. That year, the company recalled its heparin products, a type of blood thinner, following a string of severe allergic reactions and deaths. A federal Investigation revealed that the active pharmaceutical ingredient in these heparin products was contaminated with the adulterant oversulfated chondroitin sulfate. FDA deemed these contaminated heparin products “unfit for distribution” as they violated the FD&C Act and posed serious adverse health consequences to patients who received the tainted heparin.
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