Off Label Drug Marketing Fraud

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There’s a lot of money to be made in prescription drugs. Demonstrating this fact is the amount that was spent on them in 2009, and that was $300 billion for 3.9 billion prescriptions. If every person in America is included in this number, $1,000 was spent for each one on prescription drugs for this year.

The government of the United States is the number one purchaser of these drugs. As a matter of fact, the U.S. government bought more prescription drugs than anyone else in the world. A majority of these drug purchases were made by government healthcare programs, including TRICARE, Medicaid and Medicare. 

The focus has been on pharmaceutical companies that have been accused of perpetrating Medicare fraud. Furthermore, healthcare providers have also been taken to court by the U.S. government and it has prevailed in several of these cases. 

The authorities have discovered that the most common prescription drug fraud occurs when providers bill for off-label uses. What off-label use means is that the drug’s manufacturers have been marketing them for purposes for which the Food and Drug Administration (FDA) did not approve them to be used.

Every time a new drug is created, it will need to be rigorously tested before it can be sold on the open market. All of these guidelines were clearly written into the Federal Food Drug and Cosmetic Act (FDCA). 

After a drug has been approved by the FDA, how the drug should be taken and in what amounts must be clearly stated. In some cases, physicians decide to advise their patients to take the drug for other uses not asserted in the FDA’s regulations. In the purest sense, this is the definition of an off-label prescription. By the way, this is a legal practice for physicians to engage in but it is not so for a drug manufacturer. 

It would be illegal for the manufacturer to promote the use of the drug in an off-label manner but several drug manufacturers have shown that they are willing to break these laws. 

One of the most common ways manufacturers do this is to send their representatives to suggest that physicians offer the drugs for off-label uses. In order to convince them to do this, representatives are counseled to assure physicians that the manufacturers have conducted adequate studies but these studies often have flaws.

In order to combat these practices, the government wrote the False Claims Act that made it possible to discover who the perpetrators of off-label marketing are. The Act is what makes it possible for people who know of these practices to become whistleblowers on behalf of the U.S. government. Whistle blowing has made it possible for the government to recover more than $7 billion between 1996 and 2010. 

Report off label drug fraud/Medicare fraud here.

You can stop abuse of government funds by becoming a Medicare fraud whistleblower and get a substantial reward for your information. Our attorneys have a lot of experience representing those who expose fraud in the healthcare industry. To get a consultation with a lawyer free of charge, you may fill out the secure and confidential form on this page, or contact us at 1-866-648-5223.