Pfizer to Pay Largest Fine in U.S. History

Pfizer's website claims the company is "working together for a healthier world", but the world's largest drug company was recently ordered to pay a criminal fine of $1.19 billion after pleading guilty to promoting drugs for unauthorized purposes. On the same day, Pfizer shelled out an additional $1 billion to settle civil claims against Bextra and three other drugs it produces. According to company records, Pfizer executives had been instructing salespeople to promote Bextra, a drug approved only for the relief of arthritis and menstrual discomfort, for treatment of acute pains of all kinds even though patients who used the drug had increased risk of heart attacks, chest infections, and strokes. The FDA found Bextra to be so dangerous that Pfizer took it off the market for all uses in 2005.

This is the second time in five years the company has pleaded guilty to felony charges for off-label marketing. The company manufactures the drug Neurontin which was approved by the FDA in 1993 as a supplement medication for patients with epilepsy. The FDA later found that Pfizer was illegally claiming that the drug was useful for a broader range of brain disorders than scientific evidence had established. In 2004, Warner-Lambert, a Pfizer unit, pleaded guilty to two felony counts of marketing Neurontin for unapproved uses. Pfizer agreed to pay $430 million in criminal fines and civil penalties as the company’s lawyers assured prosecutors that Pfizer and its units would stop promoting drugs for unauthorized uses.

Pharmaceutical companies across the country have been pleading guilty to criminal charges or paying huge penalties in civil cases when the U.S. Department of Justice finds that they deceptively marketed drugs for unapproved purposes. Since May 2004, Pfizer, Eli Lilly & Co., Bristol-Myers Squibb Co., and four other drug companies have paid a total of $7 billion in fines and penalties. Six of the companies admitted in court that they marketed medicines for unapproved uses. Such practices put millions of people at risk of serious side effects, complications, or even death from the drugs they are taking to improve their conditions. Why do these pharmaceutical giants continue to break the law and jeopardize the lives of people who take their drugs? The answer is profit.

It used to be legal for companies to promote approved drugs for any use. In 1962, Congress banned the practice after Thalidomide, a morning sickness drug taken by pregnant women in other countries, caused severe birth defects. The law now requires pharmaceutical companies to prove their drugs are safe and effective for specific uses. In order to meet those requirements, pharmaceutical companies spend up to $1 billion to develop and test a new drug. To recoup their investment, the drug manufacturers must get doctors to prescribe their drugs as often as possible. Many drug companies find ready and willing partners in physicians. It's a common practice among pharmaceutical companies to send doctors on lavish retreats to golf resorts and exotic destinations or shower them with cash to listen to sales pitches of off-label uses for their drugs.

Under the dysfunctional system of medical regulation in the U.S., it’s legal for doctors to prescribe FDA-approved drugs for any use. The FDA has no authority over doctors, only over drug companies, regarding off-label practices; it’s up to the individual states to oversee physicians. Authorities believe most doctors don't understand the distinction between on- and off-labeling, and doctors generally don’t tell their patients that they’re prescribing drugs pitched to them by pharmaceutical salespeople for unapproved treatments. 

As prosecutors continue to uncover patterns of deceit in off-label marketing by pharmaceutical companies, millions of patients across the nation remain in the dark. Doctors often choose the medications based on dishonest marketing by drug company salesmen. Before taking a prescription, authorities recommend all people should ask whether their prescriptions are for FDA-approved uses, and if not, whether strong evidence supports using the drug, particularly if it can be dangerous.