(Reuters) - Pfizer Inc on Wednesday agreed to pay $2.3 billion to resolve criminal and civil allegations that it illegally promoted several of its drugs beyond U.S. Food and Drug Administration-approved uses and dosages.
Following are details of how it promoted the medicines and a compliance agreement to prevent future violations.
Bextra: The arthritis drug was withdrawn from the market in 2005 amid safety concerns. Pfizer was accused of promoting the medicine for acute pain and surgical pain as well as at above the approved maximum dosages.
* Penalty: Pfizer subsidiary Pharmacia pleads guilty to one felony count of misbranding; $1.2 billion criminal fine; $105 million criminal forfeiture and $502.5 million civil settlement.
Geodon: The drug is approved to treat schizophrenia and bipolar disorder, but Pfizer was accused of encouraging its use for depression, mood disorder, anxiety, dementia, attention- deficit hyperactivity disorder, autism and post-traumatic stress disorder.
* Penalty: $301.5 million civil penalty.
Zyvox: The medicine is meant for treating pneumonia and skin infections but was promoted for different kinds of infections.
* Penalty: $98 million civil penalty.
Lyrica: The drug is used to treat nerve pain but was promoted inappropriately for a variety of other pains such as chronic and perioperative pain, as well as for migraines.
* Penalty: $48.2 million civil penalty.
Pfizer was also accused of making payments to health-care providers to prescribe Bextra, Geodon, Zyvox and Lyrica as well as other kickbacks to providers as the company marketed other drugs including Aricept (Alzheimer’s), Celebrex (pain), Lipitor (cholesterol), Norvasc (hypertension), Relpax (migraines), Viagra (anti-impotence), Zithromax (antibiotic), Zoloft (depression) and Zyrtec (allergies).
Pfizer also agreed to a wide-ranging, five-year compliance program as part of its settlement.
* The company will be subject to internal and external monitoring;
* The audit committee for Pfizer’s board will have to review and certify the effectiveness of its compliance program;
* Senior company executives will certify compliance each year;
* Pfizer must set up a program for doctors to report questionable conduct by the company’s representatives as well as notify them about the settlement;
* Pfizer will have to post on its Web site payments to doctors, such as honorarium, travel or lodging.
Reporting by Jeremy Pelofsky, editing by Maureen Bavdek