GlaxoSmithKline Pleads Guilty to Massive Criminal Fraud in Marketing Drugs for Off-Label Uses

When drug companies market their products for off-label uses to doctors, hosptials, and others, consumers may be injured or die. After all, an off-label use is a use that the FDA has not found to be safe and effective. In recent years, the FDA and the Justice Department have stepped up their criminal prosecutions of drug companies that market their products for off-label uses.

Yesterday, the Justice Department announced that the Deparment along with its

law enforcement partners have reached an historic $3 billion resolution with the pharmaceutical manufacturer GlaxoSmithKline, LLC, to resolve multiple investigations into the company’s sales, marketing, and pricing practices. This action constitutes the largest health care fraud settlement in United States history. [emphasis added] It underscores our robust commitment to protecting the American people from the scourge of health care fraud. And it proves the effectiveness of the strong relationships we’ve forged with our partners to help ensure the health and safety of the American people, and to safeguard the integrity of our health care system. Under the agreements announced today, GSK will plead guilty to criminal charges and pay $1 billion in criminal fines and forfeitures for illegally marketing and promoting the drugs Paxil and Wellbutrin for uses not approved by the FDA – including the treatment of children for depression, and the treatment of other patients for ailments ranging from obesity, to anxiety, to addiction and ADHD – and for failing to report important clinical data about the drug Avandia to the Food and Drug Administration.  GSK will pay an additional $2 billion to resolve civil allegations that it caused false claims to be submitted to federal health care programs for these and other drugs as a result of the company’s illegal promotional practices and payments to physicians.  This settlement also resolves a civil investigation of the company’s alleged underpayment of rebates that were required under the Medicaid Drug Rebate Program.

Go here  to read the complaint, the plea agreements, and other information concerning the prosecution.

This AP story provides more details.

 

Comments

[telemarketing list]

The company agreed to plead guilty to three criminal counts, including two counts of introducing misbranded drugs — Paxil and Wellbutrin — and one count of failing to report safety data about the drug Avandia to the Food and Drug Administration.

[OEP]

Safe and effective. That is the issue. Any uses that are proven safe and effective become approved "on-label" uses. Off-label uses by definition have not been proven to be safe or effective to the satisfaction of the FDA. Invariably, safe and effective off-label uses become on-label. If the data were there to prove safety and efficacy, it would not be off-label.

Also, efficacy and safety are not divorced from one another. Drugs are often life-saving. If efficacy is not there, patients can die. Famously, Neurontin was ruthlessly promoted as a mood-stabilizer for bipolar disorder. Many bipolar patients suffered from lack of efficacious treatment. Some died.

And you mistake the issue at hand. There is no "crusade against off-label prescription". No patients or physicians are being prevented from using drugs off-label. The issue is that pharmaceutical companies lie as a matter of course to physicians and patients promoting drugs for off-label use, often knowing that the drug has no efficacy. Reference again to Neurontin, where Pfizer would plant people at medical conferences and send reps masquerading as physicians to promote off-label use. It has since been proven that the company knew that the drug was ineffective for those uses.

The crux of the matter is that off-label use by doctors and patients is fine. Off-label promotion by drug companies is against the law. It is entirely unreasonable to excuse this blatant deception.

[Brian]

It is true, as you say, that not having safe and effective drugs on the market can injure and kill people. Calculating risks and benefits is difficult. The question is whether you want that done by drug companies or the FDA. The FDA makes mistakes, but I’ll take the FDA, whether we are talking about initial approval of a drug or the off-label use of an already approved drug.

[John Thacker]

On the other hand, when people don't find out about off-label uses that are safe and effective (and many of them are, even though they lack FDA approval for that specific use), consumers may be injured and die. Note that even though the drugs lack FDA approval for a specific use, they have been approved for safety for other uses, leaving the biggest question about efficacy.

There are off-label uses that are well supported by science in reputable journals. Wellbutrin, aka buproprion, does cause weight loss. I don't see any particular demonstration or allegation here that on net people were actually injured or killed.

I think it's entirely reasonable to think that this crusade against off-label prescriptions (of drugs that have already been approved for safety) will kill and injured more than it will save.