Whistleblowers Expose Multimillion-Dollar Schemes and Win Big. Pharmaceutical fraud and whistleblower reward.

Kickbacks 

Kickbacks are another prevalent type of pharmaceutical fraud. In a kickback scheme, the manufacturer, supplier, or distributor of a medical device or drug offers an incentive to a healthcare provider, such as money, personal services, sponsored retreats, vacations, or opulent gifts, in exchange for the provider's prescription or sale of the product. 

Shire, which makes a human skin substitute called Dermagraft that the FDA has approved for the treatment of diabetic foot ulcers, agreed to pay a $350 million FDA whistleblower reward in 2017 to settle claims that it used kickbacks and other illegal means to persuade clinics and doctors to use or overuse the product.

To address allegations that it paid kickbacks to physicians to get them to prescribe Salix medications and medical devices, Valeant Pharmaceuticals settled for $54 million in 2016. 

Additionally, in 2016, Omnicare, a pharmacy serving nursing homes, consented to pay more than $28 million to settle claims that it approached Abbott Laboratories and accepted bribes in exchange for endorsing the company's medication, Depakote (valproic acid), for use by residents in assisted living facilities.  

Pharmaceutical fraud involving illegal kickbacks may also constitute a violation of the Anti-Kickback Statute (AKS), which prohibits healthcare providers (including physicians) from accepting bribes or other forms of compensation in exchange for generating business. Although the AKS is a separate criminal statute, a company involved in illegal kickback activity may face prosecution under both the AKS and a civil whistleblower lawsuit.  

CGMP Violations / FDA Whistleblowing 

The FDA maintains a set of regulations known as "Current Good Manufacturing Practice" regulations. The regulations are meant to guarantee the quality of drug products and apply to the manufacturing, processing, and packaging of medication. The rules guarantee that a product contains the components it says it does and is safe to use.  

When pharmaceutical corporations try to get around these rules, they violate GMP. For instance, inspectors discovered that Hill Dermaceuticals had documented production and control data in pencil rather than ink, against the company's protocols, and as a result, Hill was found guilty of a GMP violation in 2013. Additionally, some of the penciled records had been erased and then replaced in ink, and some of those rewrites differed from the original entries, according to information discovered by FDA inspectors. 

In another instance, Lupin Pharmaceuticals was found guilty of GMP violations when inspectors discovered that it was not adhering to important safety procedures requiring it to keep production records for all unexpired drugs. Lupin was also not adhering to procedures to prevent contamination of drug products, two regulations that could pose serious risks to public safety.  

Consumers are put at risk in all situations when pharmaceutical companies violate the stringent FDA regulations that guarantee the safety of drugs. An FDA whistleblower with knowledge of these regulations and insight into their employers' compliance—or lack thereof—can contribute to the protection of public safety by getting in touch with a pharmaceutical whistleblower attorney. A company's attempt to fraudulently skirt the FDA's GMP regulations may serve as the foundation for a False Claims Act (FCA) case, which could result in a sizeable FDA whistleblower reward.