Off Label Drug Promotion by Pharmaceutical Companies: How to receive a Reward for Reporting Off Label Drug Fraud
This article outlines how to receive a reward for reporting off label drug promotion fraud by pharmaceutical companies.
One of the ways drug or pharmaceutical companies cheat or commit fraud against the government is by asking, convincing or promoting doctors to prescriptions for drugs for uses that were not approved by the Food and Drug Administration (FDA), which is known as “off label” drug promotion fraud.
Examples of how pharmaceutical companies cheat through off label promotion of its drugs.
Pharmaceutical companies are not allowed to promote an “off label” or unapproved use of drugs. For instance, if the FDA approved a certain use of a drug, a pharmaceutical drug company cannot promote to doctors to prescribe the drug for another unapproved use.
A hypothetical example might be where the FDA approves drug XYZ to be used to treat epilepsy. Once receiving FDA approval, the drug company starts contacting psychiatrists to promote the potential benefits of using drug XYZ for treating depression in teens. This would be wrong because the drug company would be seeking to reap large profits by only asking the FDA to test and approve the drug for a limited area, but then sell millions of pills by asking doctors to prescribe the drug for other untested and unapproved uses.
Think of it this way. The drug company must do tests for any of the uses it wants the FDA to approve. In our example, the drug company may have performed tests on those with epilepsy, but it did not do tests to see if the same drug might work for teens with depression and it did not ask the FDA to approve the drug for that use. Rather than spend the money and time to do these tests with teens, the pharmaceutical company decides to promote to doctors that the drug is safe and effective for other off label uses, such as depression in teens. In other words, the pharmaceutical company skipped controlled drug tests and directly asks doctors to unwittingly do tests on patients without controls in place.
As an initial matter, the FDA has no authority over doctors. That means a doctor can prescribe for any use any drug that the FDA has approved for sale in the U.S. In other words, if a pharmaceutical company gets a drug approved to treat epilepsy, a doctor can prescribe it for any use, including headaches, arthritis, or depression in a teen. Of course, the label on the drug box has a list of authorized or approved uses, which, in our example, only lists epilepsy. Therefore, it is unlikely that many doctors would prescriptions for off label uses, such as headaches, arthritis, or depression in a teen without being encouraged to do so by the pharmaceutical company.
While the FDA cannot control the doctors, it has authority over the pharmaceutical companies that apply for approval for drugs. It is considered fraud and a violation of the False Claims Act for a pharmaceutical company to knowingly promote to doctors off label uses of drugs.
The guinea pigs of most “off label” drug promotion fraud cases are the elderly receiving Medicare and the poor receiving Medicaid. Even if the drug company genuinely believes the drug would work in off label uses, by law it must ask the FDA to approve the use and not simply suggest to doctors off label uses.
How to report off label drug fraud.
Off label pharmaceutical drug fraud is more common than you think. The government has already reached settlements in the hundreds of millions of dollars against more than one pharmaceutical company for promoting a single off label drug use of a drug sold to Medicare and Medicaid recipients.
Reporting off label drug fraud is ripe for rewards if you can show that a drug company is intentionally promoting off label drug uses. Indeed, there are over 4,000 FDA approve drugs. The key is that you need to have specific evidence that the pharmaceutical company is contacting doctors and promoting off label drug uses. For example, evidence includes documents where the pharmaceutical company conducted training sessions for its employees or sales force regarding the off label uses or wrote letters or emails to doctors with marketing information about off label uses. If you can show that this was a company practice by a pharmaceutical company to promote off label drug uses, you may be eligible for a very large reward.
Contact Mr. Hesch to have him assess your allegations that a pharmaceutical or drug company was defrauding Medicare or Medicaid by promoting off label use for drugs.
Other Medicare Fraud Schemes by Pharma Companies
Medicare Off label fraud is not the only type of fraud by big pharma drug companies. Click here for another one of our articles explaining the top 4 Medicare and Medicaid fraud schemes and how to receive a whistleblower reward.
See the link below “Do I have a case” to have Mr. Hesch review your potential whistleblower reward case. See the link below “Report Fraud” to learn more about the government’s whistleblower reward program.