In the largest criminal fine ever levied against any drug company in the world, a unit of U.S.-based Pfizer, Inc. was sentenced to pay $1.3 billion in criminal fines and revenue forfeiture. It's all part of a $2.3 billion settlement announced by the Justice Department. The case centers around Pfizer's criminal "off-label marketing" of four drugs, including the painkiller Bextra. After whistleblowers filed lawsuits in three states, the U.S. Justice Department took an interest in the case and prosecuted pfizer for criminal acts.
In the settlement, Pfizer admitted to a felony crime and agreed to pay $2.3 billion in fines and other fees. The investigation of Pfizer reportedly turned up evidence that Pfizer engaged in kickback payments to doctors for nine drugs, including Viagra and Lipitor.
Part of the reason the penalty against Pfizer was so large is because the company was considered a "repeat offender" in promoting drugs for unapproved uses (which is a violation of federal law).
Off-label marketing makes a mockery of modern medicineSo-called "off-label" marketing of drugs is rampant in the pharmaceutical industry. Although the FDA,drug companies and many conventional doctors claim the drug industry is guided by a "gold standard" of scientific scrutiny, the truth is that pharmaceuticals are routinely marketed and prescribed for health conditions for which they have never even been studied... much less actually approved by the FDA. The fact that this continues today makes a mockery of any "scientific credibility" the pharmaceutical industry claims to possess.
Drug companies take advantage of this gaping hole in regulatory oversight by getting their drugs approved by the FDA for one health condition, then heavily promoting it for numerous unrelated conditions. A drug approved for high blood pressure, for example, could be openly marketed for diabetes or Alzheimer's disease even though there is no evidence whatsoever showing the drug to be either safe or effective for such conditions.
The same is true with the intended demographics of pharmaceuticals: Drug companies often get their drugs approved for adults, then they market those drugs to children even though the drugs have never been tested with children.
The result is a pharmaceutical industry that appears to be highly regulated, but isn't. Virtually any drug can be pushed for any disease for almost any reason -- all with virtually no oversight by the FDA. In fact, in this Pfizer case, even with the Justice Department filing criminal charges against Pfizer, the FDA has stood by and done absolutely nothing to prevent such actions from being repeated in the future by Pfizer or another drug company. regards anusha |
