Prescription drugs are big business, very big business. The U.S. spent $300 billion in 2009 for 3.9 billion prescriptions. That equates to $1,000 per year for every man, woman and child in America.
And the biggest purchaser of all those drugs is the US government. In fact, it’s the world’s largest purchaser. Most of those purchases come under the umbrella of government-funded health care programs like Medicare, Medicaid and TRICARE.
However, the pharmaceutical industry comes under close scrutiny and has been the defendant in many cases of Medicare fraud.
The US government has successfully tried many cases involving false claims submitted by health care practitioners for fraudulent prescriptions.
One of the most common cases of fraudulent prescriptions is the submission of reimbursement for off-label uses of drugs.
Off-label prescriptions involve the marketing of drugs by drug manufacturers for uses not approved by the US Food and Drug Administration (FDA).
A new drug must undergo a rigid and strict process before being approved for sale on the US market. Those rules and regulations are contained in the Federal Food Drug and Cosmetic Act (FDCA).
When a drug receives FDA approval, its usage and dosage is explicit and restricted to only those uses and dosages.
However, doctors may, and often do, prescribe a drug for uses for which it did not receive initial FDA approval. This is what is referred to as off-label prescription.
And it’s legal for doctors to do so.
However, if a drug manufacturer actively markets a drug for such off-label uses, it is a violation of the law.
And many drug manufacturers seem willing to take this risk.
Typical scenarios include pharmacy reps directly soliciting doctors to prescribe drugs for off-label uses. They often cite scientific studies that the manufacturer has conducted, although the studies often lack validity or have procedural errors.
Or they may use false statements about a drug’s efficacy. In worst case scenarios, manufacturers have been found to offer financial kickbacks to physicians to prescribe the drugs for off-label uses.
Doctors are often vulnerable to such deception because studies show they rely on drug representatives for much of their information about drug treatments.
Dr. Jerry Avorn, from Harvard Medical School, estimates that 80% of U.S. practitioners get the majority of their drug updates from pharmaceutical sales representatives.
The US False Claims Act has been instrumental in checking and prosecuting pharmaceutical companies from these off-label practices.
The Act permits citizens to file claims of fraud on behalf of the US government against contractors or providers to the US government.
Many of the off-label marketing whistleblowers are insiders in the industry, typically pharmaceutical sales or marketing personnel. In fact, a study of whistleblower cases, from 1996 to 2010, showed 90% of whistleblowers were directly involved in selling or marketing the drugs.
The study showed that over $7 billion was recovered during that time period.
Report off label drug fraud/Medicare fraud here.
Do you have information about a drug manufacturer improperly marketing their off label drugs, thereby committing Medicare fraud? Help stop government waste and abuse, and get rewarded for your efforts. Our attorneys have significant experience representing healthcare industry whisteblowers. Complete the secure form on this page or call 1-800-581-1790 for a free no obligation consultation with a lawyer.