Pfizer to Pay Record Fine in Fraud Probe

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September 7, 2009

Pfizer to Pay Record Fine in Fraud Probe

_http://www.drrathresearch.org/health_news/ohn_090709_pfizer.html_

(http://www.drrathresearch.org/health_news/ohn_090709_pfizer.html)

In what it calls the largest health-care fraud settlement in U.S. history,

the Justice Department said Wednesday that pharmaceutical giant Pfizer

Inc. and a subsidiary have agreed to pay a $2.3 billion penalty for illegally

promoting certain drugs.

Those drugs included _Bextra_

(http://www.medicinenet.com/script/main/art.asp?articlekey=22063) , part of a

group of painkillers called _Cox-2

inhibitors_ (http://www.medicinenet.com/script/main/art.asp?articlekey=95210) ,

which Pfizer pulled from the market in 2005 after reports of potential _heart_

(http://www.medicinenet.com/script/main/art.asp?articlekey=3668) risks to

patients.

The other drugs were _Geodon_

(http://www.medicinenet.com/script/main/art.asp?articlekey=19178) , an

_antipsychotic_

(http://www.medicinenet.com/script/main/art.asp?articlekey=11993) ; _Zyvox_

(http://www.medicinenet.com/script/main/art.asp?articlekey=45189) , an

_antibiotic_

(http://www.medicinenet.com/script/main/art.asp?articlekey=8121) ; and Lyrica,

an anti-epileptic

drug, the Justice Department said in a news release.

In each case, the Justice Department accused Pfizer of marketing the drugs

for uses other than those approved by the U.S. _Food and Drug

Administration_ (http://www.medicinenet.com/script/main/art.asp?articlekey=8468)

, a

practice called " off-label " use.

According to the news release, the Food, Drug and Cosmetic Act stipulates

that a company must " specify the intended uses of a product in its new drug

application to FDA. Once approved, the drug may not be marketed or

promoted for so-called 'off-label' uses. "

Pfizer promoted Bextra for several uses and dosages not sanctioned by the

FDA due to safety concerns, the Justice Department said.

As part of the settlement, Pfizer also agreed to enter into a so-called

" expansive corporate integrity agreement " with the Department of Health and

Human Services' Office of Inspector General. That agreement calls for the

establishment of " procedures and reviews " designed to prevent a similar

occurrence, the agency said.

" Today's landmark settlement is an example of the Department of Justice's

ongoing and intensive efforts to protect the American public and recover

funds for the federal treasury and the public from those who seek to earn a

profit through fraud, " Associate Attorney General Tom Perrelli said in the

news release.

Kathleen Sebelius, secretary of the _Department of Health and Human

Services_ (http://www.medicinenet.com/script/main/art.asp?articlekey=10711) ,

said: " The Department of _Health and Human Services_

(http://www.medicinenet.com/script/main/art.asp?articlekey=10712) will

continue to seek opportunities

to work with its government partners to prosecute fraud wherever we can

find it. But we will also look for new ways to prevent fraud before it

happens. Health care is too important to let a single dollar go to waste. "

In a statement, Pfizer general counsel Amy W. Schulman said the agreement

ends all " material pending matters " with the Justice Department. " This

gives us a very important opportunity to put final closure on the universe of

material open items involving our U.S.-based operations, " she said,

Bloomberg News reported.

Author: HealthDay staff

Source _http://www.medicinenet.com/_ (http://www.medicinenet.com/)

Comments:

 

The largest drug maker in the world pleaded guilty to the U.S criminal

charges for illegal promotion of three of its drugs. Although $2.3 billion

fine is largest health care settlement in the U.S history, it is not the

one-of-a-kind for Pfizer. Judges call Pfizer a “repeating corporate cheatâ€,

for

the company has been pitching drugs to patients and doctors for unapproved

conditions, and is caught doing so, for more than once. Last October,

Arizona and 31 other states reached a $60 million settlement with Pfizer over

its promotion of Bextra, Celebrex, and another anti-inflammatory drug. Sales

and marketing executives at Pfizer are accused of promoting Bextra for

acute pain, surgical pain and other unapproved uses. Bextra was later

withdrawn from the market for the severity of its side effects, including heart

attacks and like. Bextra is of the same class as Merck’s Vioxx (cox-2

inhibitor) and another similar drug Celebrex, from Pfizer. Vioxx was withdrawn

in

2005, while Celebrex continues to be promoted and sold despite accusations

in 2009 that efficacy results of Celebrex were fabricated and some were

never submitted to the FDA. Unfortunately though, current settlement and guilty

plea is not expected to hurt Pfizer's ability to sell drugs in the future.

This is one more support to Dr. Rath's work. For more than a decade, Dr.

Rath has been fighting to expose unethical practices and motives utilized by

pharmaceutical companies only to increase their profits than to help

patients. Please read more about Dr. Rath's crusade in the book “Road Map to

Health†as well as at _http://www4.dr-rath-foundation.org/_

(http://www4.dr-rath-foundation.org/)