We Help Pharma Whistleblowers Report Off-Label Marketing Fraud and Maximize Cash Awards
Off-label marketing is one of the most dangerous types of pharmaceutical fraud. Promoting medications for FDA unapproved uses or unapproved dosages continues to harm thousands of American consumers and waste billions of taxpayer dollars on ineffective medical treatments.
Despite clear FDA restrictions on off-label marketing, pharmaceutical giants continue to promote drugs to physicians for uses that haven’t been adequately tested for safety and effectiveness - putting their own desire to increase sales over the safety of ourselves and our loved ones.
Limited government resources and an immediate threat to public safety and health care costs have prompted the FDA, Department of Justice (DOJ), and Department of Health and Human Services Office of the Inspector General (HHS-OIG) to hire pharmaceutical whistleblowers who can help detect off-label marketing fraud.
The government pays large cash whistleblower awards to physicians, nurses, pharmacists, pharmaceutical sales representatives, drug distributors, clinical trial researchers, drug manufacturers, calibration specialists, quality control specialists and others with information on off-label marketing or drug mislabeling.
At the Pharmaceutical Integrity Coalition, our mission is to offer pharmaceutical whistleblowers every tool they need to pursue a winning False Claims Act (FCA) lawsuit and put a stop to dangerous off-label marketing.
Even if you aren’t interested in filing a False Claims Act lawsuit and obtaining a cash whistleblower award, we also help whistleblowers properly format their formal complaint to ensure the FDA prioritizes it for investigation.
We do not charge anything for our services, which include:
- Optimized FCA cases for maximum cash rewards
- Aggressive, nationally renowned legal representation
- Expert pharmaceutical and FDA investigators
- Whistleblower protection in FCA anti-retaliation claims
- Confidentiality, security and privacy
Contact the Pharmaceutical Integrity Coalition toll free worldwide at +1 202.780.9957 or report anonymously at [hidden email]. (For security purposes, remember not to use a work computer or work email address when contacting us.)
How to Spot an Off-Label Drug Marketing Scheme
Pharmaceutical companies that promote their products for FDA-unapproved may be in violation of federal and state False Claims Acts when physicians, hospitals, clinics or others bill government-funded programs (Medicare, Medicaid, TRICARE) for those unapproved treatments.
Each Medicare or Medicaid bill for a prescription medication that has been illegally promoted is considered a “false claim.”
Common examples of off-label marketing that may be False Claims Act liable include:
- Delaying or suppressing release of negative data that dissuades the off-label use of a drug
- Drug companies publishing medical articles about off label uses pretending they are authored by an unbiased authority
- Encouraging pharmaceutical sales reps to discuss unsolicited off-label uses with doctors
- Encouraging physicians to prescribe a medication for off-label uses
- Examining patient medical records to determine which patients may be good candidates for off-label drug treatment protocols.
- Giving out free samples of a drug for physicians to try in FDA unapproved uses
- Making false statements about drug safety and efficacy study data
- Misbranding or mislabeling (drug label includes indications that haven’t been FDA approved)
- Offering promotional material (brochures, posters, pamphlets) or speaker statements at presentations that promote FDA unapproved drug uses
- Organizing covert physician reimbursement schemes, claim coding tactics or medical record documentation methods to disguise and bill for off-label drug uses
- Organizing lectures or continuing medical education (CME) events to promote the off-label use of a drug
- Packaging and presenting negative off-label use findings with positive findings to support off label use
- Paying physicians to support and promote the off-label use of a drug
- Paying sales reps bonuses to promote off-label uses
- Promoting a higher drug dose than the FDA approved dose
- Sending gifts or coupons to patient target populations to promote off-label prescription use
Remember, while simultaneously involved in off-label marketing schemes, your company is likely putting up all possible fronts to discourage illegal drug promotion. Pharmaceutical companies publish written policies and hold regular meetings to explicitly warn employees about the repercussions of off-label marketing.
Don’t be fooled. These verbal and written warnings DO NOT protect a company against False Claims Act liability.
The Pharmaceutical Integrity Coalition continues to work behind the scenes with the FDA, DOJ and HHS-OIG in aiding and protecting pharmaceutical company insiders who chose to come forward and report pharmaceutical marketing fraud.
Our investigative efforts and FCA claim preparation maximizes cash awards for U.S. and international pharmaceutical professionals with inside knowledge of off-label marketing schemes. Working closely with pharmaceutical experts, we understand your work environment and the challenges that blowing the whistle can present. We are here to listen to your concerns and fully protect your interests.
To report drug manufacturing violations, contact the Pharmaceutical Integrity Coalition toll free worldwide at +1 202.780.9957 or report anonymously at [hidden email]. We maintain strict confidentiality and will not share your information with others.
How Much Do Off-Label Marketing Pharma Whistleblowers Earn?
Under the False Claims Act [31 U.S.C. §3729], pharmaceutical companies whose off-label marketing violations cause government healthcare programs to receive false claims must pay a fine of $11,000 to $21,000 per false claim, plus triple the government damages.
In other words, pharmaceutical whistleblower lawsuits often recovery tens of millions to hundreds of millions of taxpayer dollars for government health care programs.
Pharmaceutical whistleblowers are paid between 15% and 30% of the total amount recovered in their FCA case.
Recent examples of off-label marketing whistleblower award amounts:
- $167.7 Million: Johnson & Johnson off-label promotion of Invega, Risperdal, Natrecor
- $65 Million: Celgene Corporation off-label promotion of Thalomid, Revlimid
- $5.1 Million: Biocompatibles Inc. off-label promotion of LC Bead
- $4.7 Million Aegerion Pharmaceuticals off-label promotion of Juxtapid
- $3.5 Million: Acclarent Inc. off-label promotion of Sinus Spacer
- $3.26 Million: CareFusion off-label promotion of ChloraPrep
In addition, federal and state False Claims Acts protect whistleblowers from employer retaliation (harassment, threats, termination, demotion, suspension) in response to their efforts to stop an FCA violation. [31 U.S.C. § 3730(h)]
Foreign nationals, non U.S. citizens and non-residents have the same rights as U.S. citizens to file a whistleblower lawsuit and receive a cash award. Many of our most valuable pharmaceutical whistleblowers are working in drug companies in Mexico, India and China.
If you suspect a pharmaceutical distributor, medical device manufacturer, drug manufacturer or other drug company of participating in off-label marketing or illegal drug promotion, we are here to protect your privacy and maximize your options. Contact the Pharmaceutical Integrity Coalition toll free worldwide at +1 202.780.9957 or report anonymously at [hidden email].