Misbranding practices create dangers for prescribers, patients
Wednesday, October 18, 2017
In recent years there has been a rise in the occurrence of drug misbranding, which has also coincided with more and more drugs being released into the pharmaceutical market.
The act of misbranding a drug can consist of falsely representing a drug or presenting a particular drug in a manner that is significantly different from its originally approved intent. This practice creates the potential for patients to experience adverse outcomes as a result of their prescribers not being appropriately informed if a drug is misbranded.
This has been the case with various companies that have been found guilty of engaging in the act of misbranding notable drugs, which is strictly prohibited by the U.S. Food and Drug Administration (FDA). Additionally, this can also bring out legal violations that can lead to companies being fined and facing other consequences as a result of their actions.
Last month, Aegerion Pharmaceuticals, Inc., became the latest company to be found guilty of drug misbranding. The Massachusetts-based subsidiary of Novelion Therapeutics has agreed to pay over $35 million for the misbranding of one of its drugs, lomitapide (Jaxatapid), which was approved specifically for the treatment of a rare genetic disease known as homozygous familial hypercholesterolemia.
The company was found to have bypassed the REMS requirements for the appropriate distribution of the drug solely based on its limited and approved indication. Aegerion expanded the drug for use in other patient populations to treat high cholesterol.
They're certainly not the first company to do this.
In 2009, Pfizer was fined $2.3 billion for misbranding the painkiller Bextra. In 2012, GlaxoSmithKline had to pay $3 billion in the largest healthcare fraud settlement ever in the U.S. for misbranding Paxil. And Johnson & Johnson was fined $2.2 billion in 2013 for misbranding Risperdal, Invega and Natrecor.
Similar to the practices observed with these three companies, Aegerion failed to give comprehensive and accurate information to both patients and prescribers about the use of Jaxatapid, which has the potential to place patients at risk if both sides are not well informed.
Both the FDA and Department of Justice have instituted a zero-tolerance policy as it relates to drug safety. When this is being jeopardized as a result of unlawful practices, strict measures are taken to address the issue.
For any drug that is misbranded, the initial performance of the benefit versus risk and the advantages versus disadvantages of the drug becomes nullified, and this places patients at grave risk. If companies neglect to perform the screening processes or measures that are put into place by the FDA and other regulating bodies, the use of a drug outside of its original intent can increase the potential for complications to arise in patients.
It is the goal of prescribers to be fully informed about the drugs they are giving to their patients, and patients place their trust in their prescribers when it comes to drug selection. If a drug is misbranded, this can jeopardize not only patient care but also the therapeutic relationship that exists between these two parties.
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