Miller and 41 other Attorneys General settle with Pfizer concerning organ transplant drug Rapamune
(DES MOINES, Iowa) Iowa Attorney General Tom Miller announced today that Iowa, 40 other states, and the District of Columbia have obtained court orders settling a consumer protection investigation of the marketing of Rapamune, a drug used to prevent organ rejection in kidney transplants. Under the settlement, Pfizer Inc., as corporate parent of Wyeth Pharmaceuticals Inc., will pay the state $537,391 and change the way the company promotes the drug to hospitals, transplant centers, health care professionals and consumers.
Miller said that the settlement was the latest in a series of cases he and other state attorneys general have pursued over the past several years involving drug makers promoting medications for “off-label” uses. “This was a particularly serious case,” Miller said. “This drug is approved for use in preventing the rejection of transplanted kidneys, but we alleged the company promoted it for preventing rejection of other organ transplants and for other uses not approved by the FDA. The drug has serious side effects when used to prevent other organ transplant rejection.”
Miller said that his lawsuit, filed with the settlement, alleged that Wyeth encouraged and directed its sales staff to promote Rapamune to doctors practicing heart, lung, liver, pancreas, and islet cell (pancreas) transplants. He said that the suit also alleged that Wyeth promoted Rapamune for use in preventing kidney transplant rejection as a conversion drug – one used after initial application of another medication, when it is only approved by FDA for use immediately after a transplant operation.
An agreement resolving the investigation, called a consent order, among other things bars Pfizer and Wyeth from:
- Providing incentive compensation for sales that may be attributable to the Off-Label uses of any Pfizer Product;
- Affirmatively seeking the inclusion of Rapamune in hospital protocols or standing orders unless Rapamune has been approved by the FDA for the indication for which it is to be included in the protocol or standing order;
- Using information describing any Off-Label or unapproved use of Rapamune unless such information and materials comply with applicable FDA regulations and the recommended actions in FDA Guidances for Industry; or
- Seeking to influence the prescribing of Rapamune in hospitals or transplant centers in any manner (including through funding clinical trials) that does not comply with the Federal anti-kickback statute.
The payment to Iowa under the settlement will go to the state consumer litigation and education fund.