Astellas Pharma US, Inc. recently settled a lawsuit claiming it violated the False Claims Act when it illegally marketed its antifungal drug Mycamine to children. The drug had been approved for use by adults, but risks to children were unknown. Astellas agreed to pay $7.3 million in penalties and fines.
Investigation into Astellas marketing actions began in 2010 after former pharmaceutical sales representative Frank Smith contacted attorneys with his complaints. The lawsuit claimed Astellas marketed its antifungal cream Mycamine for off-label use to children. Mycamine was approved by the FDA for adult treatment of the yeast fungus thrush and candida in the throat, stomach, and other parts of the body. Allegations included charges that Astellas filed claims for reimbursement under federal health care programs based on its illegal marketing of Mycamine.
The pharmaceutical company was accused of putting children at risk by claiming its drug was safe for children when there were no official studies to back up those claims. Those involved in the suit were concerned children could suffer liver failure, cardiac arrest, or kidney and blood disorders because of their exposure to Mycamine. Since the marketing of the drug was misleading, patients and their parents had no way of knowing of the dangers of Mycamine.
Two dozen states joined in the effort to recover funds paid to Astellas through Medicare, Medicaid, TRICARE, and other federal and state health care support programs. Astellas is based in Northbrook, Illinois. From the $7.3 million settlement, the federal government will receive $4.2 million and state Medicaid programs expect to receive $3.1 million. Smith, the whistleblower in the case is due to receive a total of $708,852 from the settlement. He is the first person to file a whistleblower suit in a case alleging violations of the False Claims Act.
Plaintiffs in the case were represented by Sheller PC, a Philadelphia-based whistleblower law firm. Attorneys from the firm were assisted by former Assistant US Attorney Joseph Trautwein.
Representatives in the case point out that pharmaceutical companies that put profits before people will be punished. The goal is to keep patients safe and ensure drug companies and medical care providers are not abusing federal and state health care programs. Many attorneys have made it their mission to ensure the public is protected from dangerous practices by pharmaceutical companies.
The FDA has rules in place that are intended to educate doctors and protect consumers. The goal is to ensure that all drugs that go to market are safe and that they are used for their intended purpose. Pharmaceutical companies that skirt these rules will be held accountable.
The settlement in the Astellas Pharma case demonstrates how committed authorities are to ensuring the drug market is safe for consumers. If a drug is marketed as safe or effective for something for which it has not yet been tested, makers of that pharmaceutical will be held accountable. Drug companies need to understand they will suffer consequences for violating the False Claims Act or for committing any other fraudulent activity that puts consumers at risk.