The History of Pharma Fraud and the TGA
Looking into the fraud…
- In 2014, Pfizer/Wyeth unlawfully promoted certain postmenopausal hormone therapy medications and misled Nevada consumers and physicians about the safety and efficacy of those drugs.
- In 2013, Wyeth unlawfully marketed the prescription drug Rapamune for uses not approved as safe and effective by the U.S. FDA. In addition, there were civil and criminal allegations for its uses that were not approved by the U.S. FDA.
- In 2012, Pfizer unlawfully promoted its drugs Zyvox and Lyrica. “Pfizer’s claims about Zyvox and Lyrica were not supported by scientific evidence”.
- In 2012, Pfizer’s subsidiaries bribed doctors and other health care professionals employed by foreign governments in order to win business.
- In 2012, Pfizer was using unreliable and unsubstantiated claims to promote Zyvox. Lacking evidence required by the FDA to make such claims, Pfizer allegedly relied instead upon flawed clinical studies to substantiate assertions that Zyvox was superior to Vancomycin.
- In 2011, Alpharma paid health care providers to induce them to promote or prescribe Kadian, and made misrepresentations about the safety and efficacy of the drug. The FDA had not approved the drug as safe and effective.
- In 2009, Pfizer promoted the sale of Bextra for several uses and dosages that the FDA specifically declined to approve due to safety concerns. The company was ordered to pay $1.195 billion, the largest criminal fine ever imposed in the United States for any matter. In addition, “Pfizer’s misleading claims and deceptive actions put consumers’ health at risk”.
- In 2004, Warner-Lambert illegally and fraudulently promoted unapproved uses for one of its drug products, Neurontin.
- In 2002, Pfizer fraudulently avoided paying in full the rebates owed to state and federal governments under the national drug Medicaid Rebate program for the cholesterol-lowering drug Lipitor.
- In 2000, Parke-Davis/Warner Lambert’s drug Rezulin was recalled after at least 90 liver failures and at least 63 deaths, resulting in 35.000 personal injury claims filed against Pfizer..
- In 1996, Pfizer failed to obtain proper consent for trialling a meningitis drug on 200 children in Nigeria. Eleven died and the drug was eventually prohibited for meningitis because it had a risk of complications.
- AZ will pay $520 million to resolve allegations that they illegally marketed the anti-psychotic drug Seroquel for uses not approved as safe and effective by the FDA. In addition, they failed to adequately disclose potential side effects to health care providers, and withheld scientific studies that called into question the drug’s safety and efficacy.
- AZ allegedly promoted its powerful and potentially dangerous drugs Seroquel and Crestor to Texas Medicaid providers, who primarily treated children and adolescents when those drugs were not approved as safe and effective for use in that vulnerable population.
- AZ did not provide adequate FCPA training to its sales and marketing employees in China and Russia who had routine interactions with government officials in the healthcare industry, which thereby posed a high risk for bribery and corruption.