How can someone blow the whistle on pharmaceutical fraud?
Some of the largest whistleblower awards over the years stem from pharmaceutical whistleblowers who use the False Claims Act to blow the whistle on unlawful practices such as kickbacks for prescriptions, off label promotion or other schemes to defraud programs like Medicare, Medicaid or private insurance. To blow the whistle on pharmaceutical fraud using the False Claims Act you must file the qui tam lawsuit with a whistleblower law firm and of course, you should make sure that it’s actually an actionable claim. Hundreds of millions of dollars have been given as pharmaceutical whistleblower awards over the years, spilling over to billions in whistleblower rewards given the damages these schemes create economically, which, in turn, undermine confidence in the pharmaceutical industry.
What is pharmaceutical fraud?
The U.S. Food and Drug Administration (“FDA”) enforces strict requirements on pharmaceutical products to ensure their safety and efficacy on behalf of consumers. Unfortunately, pharmaceutical companies sometimes abuse the system to cut costs and increase profits or because they’re under pressure to deliver the next best pharmaceutical product. Government programs such as Medicare, Medicaid, and TRICARE often foot the bill for illegally distributed and marketed products, costing taxpayers billions of dollars each year. In addition, the health of the American public is sometimes placed in danger by the inappropriate or unnecessary use of medical products. Please note, there’s a lot of great things pharmaceutical companies do as well, but sometimes when they go astray – they commit massive frauds with a cascade of bad decisions and the failure to do what’s right at the right time.
When a pharmaceutical product or medical equipment is prescribed for a use or purpose that has not been cleared by the FDA, that is called off-label use. Off-label use of drugs and other products poses safety concerns because the product was likely not rigorously tested for that use. Federal law prohibits companies from promoting unapproved, off-label uses that have not been demonstrated to be safe and effective. Despite this, many pharmaceutical companies resort to promoting off-label uses to increase revenue and market share which puts profits before people.
If the pharmaceutical company induces or encourages off-label uses in their marketing or promotional materials or sales methods, that may give rise to a violation of the False Claims Act. Companies have engaged in off-label marketing by employing medical professionals to encourage other providers to adopt a product for off-label use (also known as “white-coat marketing”). Medical sales representatives have also instructed providers on how to code their claims and document medical records to support reimbursement for off-label use.
Pharmaceutical sales representatives are aware of the company’s marketing strategies and may be taught to inform physicians subtly about additional potential benefits of the product — benefits that the FDA has not yet approved. In the past, off label promotions have involved claims from weight loss, to treating acne, to hair regrowth and much more.
Financial kickbacks to medical providers go hand-in-hand with off-label use and other common types of pharmaceutical fraud. By providing items of value to medical providers, pharmaceutical companies can generate lucrative prescriptions of their products regardless of whether they are safe or appropriate for the receiving patients. Although sometimes it’s just brazen with inducements of pay to play (prescribe), other times the kickbacks take a much more subtle form.
Kickbacks to medical professionals can take the form of cushy and well-paid consulting and seminar gigs, travel and vacation opportunities, free or discounted products and services, and sometimes cold hard cash . The Federal Anti-Kickback Statute strictly prohibits the provision or receipt anything of value in exchange for the prescription of any drug or medical product. A violation of the Anti-Kickback Statute is in turn a violation of the False Claims Act, which rewards whistleblowers for successful prosecution.
Even outside of the pharmaceutical context, kickbacks are commonplace in the medical community. Read more about kickbacks in healthcare here.
Fraud on the FDA
Pharmaceutical companies have also committed fraud by lying to the FDA about products and processes under its oversight. The FDA subjects new medical products to intense scrutiny prior to approval, and requires companies to provide annual reports concerning any substantial changes to the makeup or manufacturing processes of an approved product.
Companies seeking to recoup the costs of a long R&D process, or wanting to cut corners after approval, can mislead the FDA by submitting falsified reports or withholding relevant information. Products whose constituent components and manufacturing processes are not in compliance with the FDA’s protocols are considered adulterated, and may not be distributed in commerce. Companies which allow these noncompliant products to be paid for by government programs like Medicare can face damages and penalties under the False Claims Act.
Reporting Pharma Fraud in Healthcare the Right Way
Over the years, whistleblowers have helped the government recover billions of dollars by reporting unethical and illegal schemes perpetrated by pharmaceutical companies. These whistleblowers helped to protect patients, taxpayer dollars, and the integrity of the healthcare system.
Pharmaceutical insiders who witness illegal marketing or other kinds of fraud can provide an important public service and receive financial rewards by blowing the whistle the right way. However, if you blow the whistle the wrong way without consulting an experienced attorney, your case could be over before it begins. To understand your rights as a pharmaceutical whistleblower you should consult with our qui tam team by calling (877) 561-0000 for a free, confidential consultation.