Drug giant GlaxoSmithKline has pleaded guilty to promoting off-label drug uses and hiding important safety information from the public. The penalty in this case is $3 billion, which is the third-largest fraud settlement in U.S. history.
A civil settlement will accompany the criminal case in which Glaxo was accused of improper marketing practices and providing doctors with “expensive resort vacations, European hunting trips, high-paid speaking tours and even tickets to a Madonna concert.” The Deputy Attorney General, James M. Cole, has stated that this fine will be the largest paid by a drug company. As part of the penalty, Glaxo has also had to agree to be monitored by government officials for as long as five years as a means for the government to ensure that Glaxo remains compliant.
“Let me be clear, we will not tolerate health care fraud,” Cole told a news conference at the Justice Department.
“For far too long, we have heard that the pharmaceutical industry views these settlements merely as the cost of doing business,” Acting Assistant Attorney General Stuart F. Delery, head of Justice’s civil division, said at the news conference. “That is why this administration is committed to using every available tool to defeat health care fraud.”
For the company’s part, CEO Sir Andrew Witty has stated that the company has learned its lesson.
“Today brings to resolution difficult, long-standing matters for GSK,” Witty noted. “Whilst these originated in a different era for the company, they cannot and will not be ignored.”
Drug manufacturers like Glaxo (the makers of Paxil) have long been accused of failing to warn the public and healthcare professionals about the dangers linked to taking their medications, including Paxil. Crimes like the ones in this case by drug companies have been too common because the companies expect a certain amount of financial liability and continue to break the law. These fines are often handed down because the companies aggressively pursue doctors to promote their drugs before they are even approved for use by the FDA. Some companies even go so far as to offer kickbacks to doctors and hospitals that prescribe their drugs.
One of the drugs brought up in this case against Glaxo was Paxil. Glaxo was accused of “illegally promoting the drug Paxil for treating depression in children from April 1998 to August 2003, even though the FDA never approved it for anyone under age 18.” Paxil is an SSRI antidepressant medication that is used to treat severe depression and anxiety disorders. The drug has been found to cause serious side effects, including violent and suicidal thoughts and behavior and birth defects (PPHN, cleft palate and heart, lung and brain defects) in babies whose mothers take the drugs while pregnant.