The U.S. Food and Drug Administration (FDA) has broad authority to evaluate and approve drugs for medical use or prescription drugs. It also has the authority to investigate fake or counterfeit medicines and substances in the entire pharmaceutical industry. Unfortunately, the Food and Drug Administration (FDA) relies heavily on healthcare providers and professionals – especially doctors and pharmacists – to spot counterfeits or unapproved drugs. Rather than merely deputizing these healthcare professionals, though, the FDA puts the onus on them to take counterfeit drugs out of the supply chain. This has serious implications: If you prescribe or dispense counterfeit drugs, you can be held legally liable, even though you were not the one who made the fake drugs substance, and even if there was little that you could have done, differently.
This can come as a shock to healthcare providers in the U.S. Here are four things that Dr. Nick Oberheiden, an FDA defense lawyer from Oberheiden P.C., thinks that healthcare providers should know about the FDA’s counterfeit drug investigations.
The Four Forms of Counterfeit Drugs
According to the FDA, drugs can be counterfeit in four different ways. They can be:
- Fake, ineffective, contaminated, or unsafe in some other way
- Unapproved or even unevaluated by the FDA
- Composed of too much or too little of the active ingredients that they were designed to have
- Filled with harmful ingredients
Many instances of counterfeit drugs fall into more...
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