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Wyeth forced to pay half a billion dollar fine for illegal marketing of Rapamune drug

Wednesday, August 07, 2013 by: J. D. Heyes
Tags: illegal marketing, Big Pharma, Rapamune

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(NaturalNews) Big Pharma Wyeth will pay nearly a half-billion dollars in penalties to resolve criminal and civil liability arising from improper marketing of its prescription drug, Rapamune.

According to the Department of Justice, Wyeth - which was acquired by Pfizer, Inc., in 2009 - was illegally marketing the drug for uses that had not been approved "as safe and effective by the Food and Drug Adminitration."

The department said the drug is an "immunosuppressive" that ensures the body's immune system does not reject a transplanted organ.

'We will hold them accountable

"FDA's drug approval process ensures companies market their products for uses proven safe and effective," said Stuart F. Delery, acting assistant attorney general for the Justice Department's Civil Division. "We will hold accountable those who put patients' health at risk in pursuit of financial gain."

Under provisions of the federal Food, Drug and Cosmetic Act (FDCA), pharmaceutical companies must specify the uses of medications in all new drug applications to the FDA. Once those meds are approved for certain uses, they cannot be marketed for others that were not initially approved by the government.

Per the Justice Department's press release announcing the $490.9 million settlement:

The Federal Food, Drug and Cosmetic Act (FDCA) requires a company such as Wyeth to specify the intended uses of a product in its new drug application to the FDA. Once approved, a drug may not be introduced into interstate commerce for unapproved or "off-label" uses until the company receives FDA approval for the new intended uses. In 1999, Wyeth received approval from the FDA for Rapamune use in renal (kidney) transplant patients. However, the information alleges, Wyeth trained its national Rapamune sales force to promote the use of the drug in non-renal transplant patients.

Pushing non-approved usage to generate profits

The department said Wyeth provided its sales staff with training materials pertaining to non-renal transplant usage, as well as how to use said materials in presentations to transplant doctors. In addition, the company encouraged sales staff, using financial incentives, "to target all transplant patient populations to increase Rapamune sales," the department said.

"The FDA approves drugs for certain uses after lengthy clinical trials," said Sanford Coats, U.S. Attorney for the Western District of Oklahoma.

"Compliance with these approved uses is important to protect patient safety, and drug companies must only market and promote their drugs for FDA-approved uses. The FDA approved Rapamune for limited use in renal transplants and required the label to include a warning against certain uses," he continued. "Yet, Wyeth trained its sales force to promote Rapamune for off-label uses not approved by the FDA, including ex-renal uses, and even paid bonuses to incentivize those sales. This was a systemic, corporate effort to seek profit over safety. Companies that ignore compliance with FDA regulations will face criminal prosecution and stiff penalties."

The company pleaded guilty to charges it misbranded the drug under the provisions of the FDCA. Resolution of the case "includes a criminal fine and forfeiture totaling $233.5 million," said the Justice Department.

Hundreds of millions in fines

Wyeth pleaded the charges out, agreeing to pay an additional criminal fine of $157.58 million and forfeit assets of $76 million. The department said the plea agreement has been accepted by the U.S. District Court in Oklahoma City.

According to the initial complaint, the government alleged that Wyeth also violated the False Claims Act in its off-use marketing campaign of Rapamune, from 1998 through 2009. Some of the uses for the drug marketed by Wyeth were not medically accepted indications, "therefore were not covered by Medicare, Medicaid and other federal health care programs," Justice said.

Wyeth will pay $230,112,596 to the federal government and $27,287,404 to the states, the department said.

"Wyeth's conduct put profits ahead of the health and safety of a highly vulnerable patient population dependent on life-sustaining therapy," said Antoinette V. Henry, Special Agent in Charge, Metro-Washington Field Office, FDA Office of Criminal Investigations. "FDA OCI is committed to working with the Department of Justice and our law enforcement counterparts to protect public health."





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