Whistleblowers are often vilified by those that they seek to bring to justice, and naturally, it is sometimes hard to see the forest through the trees. Most times, once the news has broken, the whistleblowing hero is painted in a demonic light, while it usually takes a while for the real villain to be exposed. 

Whistleblowers the world over have been in need of the right type of legal representation to give them the best fighting chance in a seemingly lopsided affair. 

A professional, knowledgeable, and expert pharmaceutical whistleblower attorney from Oberheiden P.C. specializes in keeping whistleblowers on the side of freedom. After all, whistleblowers are the true heroes of our age, and they deserve to be treated as such. 

Being one of the most lucrative industries in the world today, the pharmaceutical industry is ripe for all kinds of fraudulent activities and schemes. With that amount of money involved, kickbacks and under-the-table deals are unfortunately more commonplace than anyone wants to admit. 

Over the past number of years, with the mainstream inception of whistleblowers as a necessary means to a positive and productive end, whistleblowers have uncovered hundreds of millions, stretching into the billions of dollars of fraudulent transactions between pharmacies, pharmaceutical companies, and Pharmacy Benefit Managers (PBM).

These frauds, cascading into hundreds of cases, have ended up costing the healthcare system billions of dollars. Let us take a look at some of the most common cases of fraud that are present in the pharmaceutical industry today. 

Unlawful Kickbacks

It should come as no secret that the pharmaceutical industry has a huge influence over doctors and the way that they prescribe medication. Unlawful kickbacks to doctors come in the form of luxury vacations, expensive cars, meals, and even consulting fees (cash).

These are given to doctors for them to prescribe and distribute a certain company’s product almost exclusively, therefore increasing this company’s sales and revenue at the end of the day.

Off-Label Marketing

According to the FDCA (Food, Drug, and Cosmetic Act), pharmaceutical companies may not promote their drug for dose, use, or populations that have not been specifically approved by them. This is known as “off-label” marketing or promotion and is in direct violation of FDCA policies. 

For example, this could include a drug that has been approved for use in treating severe psychiatric disorders, while the drug company’s salesperson promotes it for widespread use in nursing homes for the calming of elderly patients. 

Clinical Trial Manipulation/ Fraud Against the FDA

Before marketing a new drug, drug companies need to get the approval of the FDA (Food and Drug Administration). The FDA then approves the drug based on the fact that it has been proven to be safe, effective, and properly labeled. 

This is done after extensive trials on the drug have been conducted to establish a wealth of information regarding the drug’s safety, pharmacology, efficacy, and toxicity.

Pharmaceutical companies that submit false claims and false or misleading information regarding their new drug to the FDA, if they omit material data that is relevant to their NDA (New Drug Application), or if they choose to misrepresent the safety or efficacy of their drug during clinical trials, may be liable to the False Claims Act (FCA) liability. 

Illegal Drug Switching

As a rule of thumb, pharmacists must issue a patient’s prescription as it has been written by the prescribing doctor. Here, we are not talking about substituting brand-name drugs for their generic counterpart, but rather, drug switching involves substituting one drug for another or perhaps dispensing a liquid form of the drug when a pill or tablet has been prescribed. 

It may be a violation of the False Claims Act, that is, billing government insurers for medications that have been manipulated in such a manner. 

Fraud by Pharmacy Benefit Managers (PBMs)

PBMs are third party administrators of prescription drug programs for a host of programs, including Medicare Part D plan. Because of this, they are often a common target for fraud investigations. 

Through negotiations, manufacturer rebates, cost-sharing, generic substitutions, and other methods, PBMs are able to contract with health plans to provide them with medications at lower prices.

Fraud is committed by PBMs when they fail to pass on these rebate savings arrangements to clients, thus developing formularies that are in favor of the more expensive drugs, as well as improperly switching drugs to either a generic or different brand name as opposed to what has been prescribed. 

The drug manufacturers can, for example, be committing fraud when they provide a price concession for a certain drug in exchange for the PBM’s more favorable coverage of said drug.

Medicare Part D Fraud

Also referred to as the Medicare Prescription Drug Program, Part D provides drug coverage for tens of millions of elderly and disabled Americans. Through the program, private insurance companies provide those that are eligible with pharmaceuticals, either directly, or by way of PBMs. These claims are then submitted to Medicare for the cost of the drugs. 

Fraud in this process can be committed in the following ways:

• Billing for drugs that are not actually provided
• Billing for drugs not covered by Medicare
• Billing for brand-name drugs when generics were used instead
• Billing for opioids and other controlled substances that are repurposed for illegitimate uses
• Billing for drugs that have expired
• Billing for drugs dispensed without a prescription or a prescription that has been falsified
• Billing for drugs provided in quantities that exceed the approved limits
• Billing for drugs that have been dispensed with prescriptions that have been issued by unauthorized, excluded, or non-existing healthcare providers

Whistleblowers are the lifeline between a corrupt system that is being bled dry and a prosperous future that we all deserve. With the abuse that the health system is taking, the future looks bleak for those who are in need of it the most. Whistleblowers need protection and legal counsel who know how the industry works and how it should not work. Pharmaceutical whistleblower claims attorneys are there to help, so do not let corruption rule the day, and ruin the lives of millions all for their own selfish gain.

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