The U.S. Food and Drug Administration (FDA) is tasked with regulating the tens of thousands prescription and over-the-counter drugs we consume each year. Unfortunately, drug manufacturers illegally markets its drug for uses outside its approved use in an attempt to boost sales and pad the bottom line. Such is the case in the details surrounding the latest $490 million settlement paid by drug conglomerate Wyeth Pharmaceuticals following the DOJ’s investigation into its marketing of the anti-rejection drug Rapamune for the treatment of conditions not listed in its approval.
If the Drug is Helping People, What Did Wyeth Pharmaceuticals Do Wrong?
The FDA is designed to protect American consumers from unsafe drugs. Its goal is to ensure that all patients receive full disclosure of the drugs likely side effects when taken for its intended use. For this reason, drug manufacturers are required to engage in extensive and lengthy clinical trials to test the drugs in a variety of settings upon a variety of patients. Once the testing is complete, the drug manufacturer must report incidents of adverse reactions and the statistics surrounding the drug’s effectiveness. Once the FDA has reviewed the trials, it will approve the drug for use for the intended condition as stated by the drug maker at the outset of the process. This complex approval process is replete with checks and balances and is designed to instill consumer trust and faith in a logo touting “FDA-Approved.”
In this case, Wyeth Pharmaceuticals decided to circumvent the often-years-long testing phase and market its drug Rapamune outside of its FDA-approved use: anti-rejection medication for kidney transplant patients. According to allegations in the DOJ’s complaint and subsequent settlement release, Wyeth intentionally and systematically trained its sales staff to market the drug for use by any and all transplant patients – a gross deviation from its intended and tested use limited solely to renal patients.
How Did the DOJ Calculate the $490 Million Settlement Amount?
Litigation against Wyeth Pharmaceuticals involved nearly one dozen federal agencies, including those that handle Medicaid, Medicare and TRICARE claims, the Department of Health and Human Services, the FBI and many others. Wyeth was required to pay $257.4 million in civil damages to the federal and state governments for collecting Medicare, Medicaid and TRICARE coverage for patients using Rapamune for non-approved use, as well as a near-equal amount in criminal sanctions surrounding the fraudulent marketing perpetrated on unsuspecting transplant patients. The settlement is actually the result of two whistleblower lawsuits filed by a former sales representatives and a pharmacist.
Help Protect Others From Fraudulent Drug Marketing
Whistleblower lawsuits are pivotal in maintaining integrity and honest financial reporting in the private sector – particularly for companies holding sizable government contracts. The longer drug companies are able to get away with circumventing the FDA’s rules and regulations in favor of their own bottom line, the more likely an unsuspecting transplant patient will suffering irreversible consequences from taking a drug not suited to that patient’s condition. While it may seem daunting to commence a claim against a global drug conglomerate, understand that by blowing the whistle on this unacceptable behavior, you are potentially saving others from the potential side effects of drugs like Rapamune and may cause companies like Wyeth Pharmaceuticals to think twice before marketing drugs for conditions not disclosed to the FDA.