Posts Tagged ‘unapproved use’

Johnson & Johnson Internal Documents Reveal Unsavory & Potentially Illegal Marketing of Antipsychotic drug Risperdal

Friday, March 12th, 2010

InjuryBoard.com
By Jim Lewis
March 12, 2010

The multi-billion dollar drug company, Johnson & Johnson (J&J), has come under fire for allegedly violating the rules in their marketing of Risperdal, an antipsychotic drug. Back in 1999, the Food and Drug Administration (FDA) told J&J that their marketing materials for geriatric patients overstated Risperdals benefits and minimized risks, according to Bloomberg.com. In 2000, an internal business plan strategized a way to increase Risperdals market share by marketing the benefits for elderly dementia, an unapproved use.

This was described as one of the more egregious examples of marketing drugs to vulnerable patients by Jerry Avorn, who works at the Harvard Medical School. He went on to say, seeing such clear evidence in black and white of the details of a campaign like this is still pretty upsetting.

J&Js marketing of Risperdal could be illegal since current law states that drug companies cannot promote a drug for uses other than those approved by the FDA. At the time this marketing and business plan was crafted, Risperdal was only approved for psychotic disorders like schizophrenia, not for dementia.

Read entire article:  http://virginiabeach.injuryboard.com/fda-and-prescription-drugs/johnson-johnson-internal-documents-reveal-unsavory-and-potentially-illegal-marketing-of-risperdal.aspx?googleid=279316

« Return to news items


Share

Internal documents show drug company marketed their antipsychotic Risperdal for unapproved usage on elderly & kids

Wednesday, March 10th, 2010

Bloomberg.com
By Margaret Cronin Fisk, Jef Feeley and David Voreacos
March 10, 2010

Johnson & Johnson made plans to reach $302 million in geriatric sales for its antipsychotic Risperdal just months after federal regulators said the company falsely claimed the drug was safe and effective with the elderly, according to internal documents.

The U.S. Food and Drug Administration told J&J in 1999 that its marketing materials for geriatric patients overstated Risperdal’s benefits and minimized risks. A J&J business plan for the next year called for increasing the drug’s market share for elderly dementia sales, an unapproved use, according to newly unsealed documents in a lawsuit by the state of Louisiana.

“The geriatric market represents Risperdal’s second wave of growth,” J&J officials wrote in the business plan. “The aging population will continue to drive market growth well into the next century.”

Louisiana officials cited the document and dozens of other internal J&J files in its lawsuit claiming the company marketed Risperdal to the elderly and children for unapproved uses. Professor Jerry Avorn of Harvard Medical School, who isn’t involved in the case, called the papers “one of the more egregious examples” of marketing drugs to vulnerable patients.

“By 2010, most grownups in medicine know that drug companies resort to unsavory practices to promote drugs, but seeing such clear evidence in black and white of the details of a campaign like this is still pretty upsetting,” Avorn said.

Read entire article:  http://www.bloomberg.com/apps/news?pid=20601109&sid=ag4Ya8UOIob0&pos=13

« Return to news items


Share