Articles Posted in off label marketing

The Irish drug manufacturer Amarin, has filed a lawsuit seeking to limit the powers of the Food and Drug Administration (FDA) in prohibiting so called “off  label” promotion of uses of drugs. The FDA gives approval of specific uses of drugs after reviewing the proper testing data submitted by the drug companies. That approval is the “on label” use allowed. However, many drug companies promote and sell their drugs to physicians for different uses. The lawsuit seeks to have a federal court rule that the FDA prohibitions of off-label promotion violates the company’s First Amendment rights and that its sales representatives should be able to convey off label uses to doctors.

Amarin filed the suit after the FDA denied the company the right to sell its prescription fish-oil pill Vascepa to individuals who do not have very high levels of triglycerides, a fat in the blood which can lead to heart disease. Presently the oil is allowed to be marketed only to individuals with very high levels of triglycerides. The pharmaceutical companies want more freedom to promote their products without constraint. Patient advocates say that this would undermine the drug-approval process and essentially allow the companies to go around the FDA.

The issue of off –label drug promotion is a problem with wide scale dimensions involving billions of dollars to the drug manufacturers. In November 2013, John & Johnson paid $1,391 Billion to settle a False Claims Act case for its off-label promotion of Risperdal, Invega and Natrecor. Risperdal had been approved only to treat schizophrenia by Janssen, a Johnson and Johnson subsidiary promoted it to physicians to treat elderly dementia patients for symptoms such as anxiety, agitation, depression and confusion. Continue reading

Johnson & Johnson has agreed to pay more than $2.2 BILLION to resolve state and federal charges of improper selling of prescription drugs for uses other than approved uses by the FDA and for paying kickbacks to doctors and a pharmacy to increase sales.

The settlement is the largest of its kind for health care and relates to sales of Risperdal, approved for use by the FDA for schizophrenia but marketed by J&J’s subsidiary to treat elderly dementia patients to treat symptoms of anxiety, agitation, depression and confusion. The government investigation revealed that Janssen, the subsidiary, emphasized symptoms and minimized any mention of the FDA approved use for schizophrenia.

The company also promoted the drug for use in children and the government said the company knew it posed special health risks for children. The company instructed its representatives to call on child psychiatrists and to market Risperdal as safe and effective for symptoms of various childhood disorders. The drugs was not approved for use in children for any purpose.

Drugmakers  have found a way to make more money by defrauding Medicare by marketing the off label uses of drugs to nursing home patients. This large group of helpless, hapless people can do nothing to stop being used as guinea pigs.

One example is Par Pharmaceuticals which paid $45 million this year to settle federal charges that it promoted Megace ES, a drug treatment approved for appetite loss in AIDS patients. Instead, PAR pushed the produce for nursing home and hospice residents. In court documents the government said that the Par reps and management knew that they called on very few facilities with AIDS patients. They sold it instead to the old people.

In addition, the use of antipsychotic drugs in nursing homes is rampant–all billed to Medicare.Nationwide, 25 percent of nursing home patients are on antipsychotics, according to a study by the federal Centers for Medicare & Medicaid Services. It is even more widespread in North Jersey, where facilities report up to 37 percent of their patients have been given the drugs.

James Wetta is a multi-millionaire from his activities as a whistleblower of the pharma industry–not once by twice and his recent revelations concerning AstraZeneca will result in $45 million to him. The former AstraZeneca sales rep filed a whistleblower lawsuit against the company in 2004 and Astra revealed last week that it would pay$520 million to settle the inquiry into its marketing of the antipsychotic Seroquel. Interestingly, the whistleblower has done this before when he blew the whistle on Eli Lilly, which last year paid upwards of $1.4 billion to settle an antipsychotic marketing issue. Wetta got a share of the $100 million of the whistleblower portion of that settlement. According to his Astra suit, Wetta received negative evaluations at work after refusing to participate in the off-label marketing of Seroquel to child and adolescent psychiatrists, primary care doctors and elderly dementia sufferers. He was let go, he claims.
These type of activities are increasingly to subject of whistleblower cases revealed by employees or terminated employees who refuse to go along with the wrongdoing.

Astra Zeneca agreed to pay $520 million to settle charges it illegally marketed the anti-psychotic drug Seroquel. The wrongdoing was originally revealed by a whistleblower under The False Claims Act. The company was accused of promoting the drug’s use for multiple illnesses never approved by the Food and Drug Administration. By promoting Seroquel for off-label uses, the company caused false payment claims to be submitted to various federal programs including Medicaid and Medicare. The allegations were originally raised in a lawsuit under the whistleblower provisions of the False Claims Act.

Seroquel was originally approved for the treatment of psychotic disorders in September 1997, followed by short-term treatment of schizophrenia, acute manic episodes associated with bipolar disorder and bipolar depression during the next decade.

However, from January 2001 to September 2006, AstraZeneca allegedly also marketed the drug to psychiatrists and other physicians for aggression, Alzheimer’s disease, anger management, anxiety, attention deficit hyperactivity disorder, bipolar maintenance, dementia, depression, mood disorder, post-traumatic stress disorder, and sleeplessness. The company allegedly targeted doctors who don’t typically treat schizophrenia or bipolar disorder, promoted the off-label uses in medical education programs, and recruited doctors to serve as the named authors of articles that were ghostwritten by medical literature companies.