We Help Pharmaceutical Professionals Report Fraud and Maximize Cash Awards
Pharmaceutical companies, drug manufacturers, biotechnology outfits, medical device manufacturers and other companies regulated by the U.S. Food and Drug Administration (FDA) continue to engage in fraud, waste and abuse of valuable taxpayer dollars.
Tragically, fraudulent practices in the pharmaceutical industry not only increase U.S. healthcare costs, but also put the lives of all American citizens in danger.
If you have knowledge of FDA current good manufacturing practices (cGMP) violations, illegal kickbacks, off label marketing, pay to delay schemes, best price fraud, clinical trial fraud, or other forms of pharmaceutical fraud, you may be eligible to file a pharmaceutical whistleblower lawsuit and collect a large False Claims Act (FCA) cash award.
At the Pharmaceutical Integrity Coalition, we believe only the highest-quality pharmaceutical development and distribution can guarantee the safety of every American consumer. Our mission therefore is to provide pharmaceutical whistleblowers with every possible tool and safeguard necessary to ensure a successful FCA claim.
Those who report pharmaceutical fraud through the Pharmaceutical Integrity Coalition and wish to pursue an FCA lawsuit receive:
- Superior-quality, FCA-specialized legal representation
- Skilled team of FDA case investigators
- Aggressive pharmaceutical whistleblower rights protection
- Assertive privacy and confidentiality security
- Case preparation optimized for maximum cash award amount
The Pharmaceutical Integrity Coalition represents U.S. and international drug and medical device quality assurance (QA) professionals, pharmaceutical sales representatives, drug calibration specialists, drug and medical device company executives, public health administrators and other drug safety or quality control specialists with knowledge of pharmaceutical FCA violations.
Our goal is to ensure your case is successful, the wrongdoer is held accountable, the illegal activity stops, your rights are protected, and your cash award is maximized.
Your privacy is of utmost importance. All inquiries are kept strictly confidential. Contact the Pharmaceutical Integrity Coalition toll free worldwide at +1 202.780.9957 or report anonymously at [hidden email].
What Types of Pharmaceutical Fraud Violate the False Claims Act?
When domestic and international drug distributors, pharmaceutical manufacturers, medical device companies, compounding pharmacies, and other medical entities are involved in billing government-funded programs (Medicare, Medicaid, TRICARE) for products or services that do not comply with FDA regulations or the Federal Food, Drug and Cosmetic Act, they may be in violation of the False Claims Act.
Common examples of activities by pharmaceutical companies that violate the False Claims Act include:
- Best price fraud: Failing to accurately report a drug’s “best price” to the Center for Medicare and Medicaid Services (CMS) under the Medicaid Rebate Program (used to calculate reimbursement rates) in order to illegally decrease rebate liability. May also include 340B program price fraud and other illegal price inflation.
- Clinical trial fraud: Misrepresenting clinical trial data in FDA approval applications, including data on adverse drug effects or drug effectiveness, falsely claiming biosimilarity or substantial equivalence to approved drugs or devices (FDA 510(k) fraud), paying uninvolved, influential doctors to list themselves as an author in clinical papers supporting off-label marketing (ghostwriting), or designing trials to market a drug or device rather than to test its safety and efficacy (seeding).
- FDA good manufacturing practice (GMP) violations: Failing to perform appropriate record keeping, laboratory controls, manufacturing protocols, equipment maintenance, facility maintenance, personnel training, batch testing, etc., in line with required FDA GMP regulations.
- Illegal kickbacks: Offering financial or other incentives (cash bonuses, free vacation expenses, lavish dinners, gifts) in return for customer referrals.
- Manufactured compound drugs fraud: Manufacturing compounded drugs (whether equivalent to commercially available drugs or not) outside of FDA approval, including making medically unnecessary compounds, unprescribed compounds, or working under the guise of a compounding company to mass produce FDA-unapproved substitute drug formulations.
- Off label marketing: Marketing or promoting a drug for a use that is not FDA approved, including making verbal statements or supplying materials that promote an FDA-unapproved use, or “misbranding” a drug’s label to include information about unapproved uses.
- Pay for delay schemes: Brand-name pharmaceutical companies offering payments to generic drug manufacturers to delay introduction of their generic drug into the market in order to sidestep patent competition. Also known as reverse payment agreements.
- Pharmacy benefits manager fraud: Failure of third-party pharmacy benefit manager (PBM) networks (Medicare Part D Prescription Drug Plans, Medicare Advantage Plans, Federal Medicaid programs) to properly process prescriptions, negotiate prices and manage rebates with drug manufacturers and pharmacies, including retaining rebates, classifying rebates as purchase discounts, dispensing expired products, redistributing returned products and therapeutic switching.
Our pharmaceutical whistleblower advocates are world renown for representing whistleblowers in the most complex cases of pharmaceutical fraud. The Pharmaceutical Integrity Coalition continues unrivalled success in earning record whistleblower awards for U.S. and international pharmaceutical industry professionals with knowledge of pharmaceutical fraud.
To report pharmacy fraud, contact the Pharmaceutical Integrity Coalition toll free worldwide at +1 202.780.9957 or report anonymously at [hidden email].
FDA Pharma Whistleblower Awards, Protection and Privacy
Under the federal False Claims Act, drug companies who violate FDA regulations, causing false claims to be billed to government-funded programs, must pay a fine of $11,000 to $21,000 per false claim, plus triple damages [31 U.S.C. §3729].
When a whistleblower’s information leads to a successful government verdict or settlement, the whistleblower is entitled to between 15% and 30% of the total government recovery.
Government recovery amounts for pharmaceutical FCA cases can easily fall in the ten-million to hundred-million-dollar range, making pharmaceutical whistleblower cash awards significant. In 2017 alone, the federal government paid out $635 million to whistleblowers. Recent examples include:
- $800 million - Abbott
- $786 million - Wyeth & Pfizer
- $650 million - Merck
- $2 billion - GlaxoSmithKline
- $1.720 billion - Johnson & Johnson
- $1 billion - Pfizer
In addition to significant cash incentives for blowing the whistle, the False Claims Act also provides anti-retaliation provisions that protect employees from discharge, demotion, suspension, threats, harassment, or any other form of discrimination in response to the employee seeking to stop the employer from violating the False Claims Act. [31 U.S.C. § 3730(h)]
At the Pharmaceutical Integrity Coalition, we understand that your privacy and confidentiality is vital to the success of your pharmaceutical whistleblower case. Our advocates work to maintain your privacy and conceal your identity for as long as legally possible. In most FCA cases, a whistleblower’s identity will remain unknown throughout investigation of the case.
If you have knowledge of a drug manufacturer, compounding pharmacy, pharmaceutical company or distributor that is deceiving the FDA, Medicaid, Medicare or Tricare, contact the Pharmaceutical Integrity Coalition toll free worldwide at +1 202.780.9957 or report anonymously at [hidden email].
Don’t Be Daunted by Big Pharma
With the best legal and investigative support in the nation backing your FCA suit, no pharmaceutical or biotech company is too large to fight. We represent pharmaceutical whistleblowers from the world’s largest, most powerful companies, including:
- Abbott Laboratories (USA)
- AbbVie (USA)
- Alexion Pharmaceuticals (USA)
- Allergan (IRL)
- Amgen (USA)
- Astellas (JPN)
- AstraZeneca (GBR)
- Bayer (DEU)
- Biogen (USA)
- BioMarin (USA)
- Bristol-Myers Squibb (USA)
- Celgene (USA)
- Daiichi Sankyo (JPN)
- Eisai Pharmaceutical (JPN)
- Eli Lilly & Co (USA)
- Gilead Sciences (USA)
- GlaxoSmithKline (GBR)
- Illumina (USA)
- Incyte (USA)
- Johnson & Johnson (USA)
- Merck & Co. (USA)
- Mylan (USA)
- Novartis (CHE)
- Novo Nordisk (DNK)
- Perrigo (USA)
- Pfizer (USA)
- Regeneron Pharmaceuticals Inc (USA)
- Roche (CHE)
- Sanofi (FRA)
- Shire Pharmaceuticals (IRL)
- Stryker Corporation (USA)
- Takeda Pharmaceutical (JPN)
- Vertex Pharmaceuticals (USA)
- Zoetis (USA)
Americans depend on pharmaceutical giants like these to provide safe, effective medications for our families and loved ones. Don’t hesitate to voice your concerns. You could save a life.
Act Now and Report Pharmaceutical Fraud. You May be Eligible for a Reward.
If you feel you have knowledge of fraudulent activities involving the FDA, Medicaid, Medicare or TRICARE, you may be eligible to file a pharmaceutical whistleblower lawsuit and collect up to 30% of the recovery as a cash reward.
Remember, only the first to report fraud is eligible for an FCA whistleblower award. Time limits may apply to your case.
Solidify your role as whistleblower today and help put a stop to the dangers of pharmaceutical fraud. Contact the Pharmaceutical Integrity Coalition toll free worldwide at +1 202.780.9957 or report anonymously at [hidden email].