Pfizer Facing Lipitor Probe ; Union Plan Files Suit Over Drug Marketing
By JEFFREY GOLD, THE ASSOCIATED PRESS
NEWARK Pfizer Inc. on Tuesday said it is cooperating with a federal investigation into whether it is improperly marketing Lipitor, a cholesterol-lowering drug that is the world’s top- selling medicine.
“We do not know who initiated or why an investigation was initiated in Brooklyn, but we have been cooperating with that investigation, and have seen no merit in any of the claims in that matter,” a spokesman for Pfizer, Andrew B. McCormick, said in an e- mail Tuesday.
The investigation was disclosed in Tuesday’s editions of The Wall Street Journal.
A spokesman for the U.S. Attorney’s Office in Brooklyn, N.Y., Bill Muller, said its policy is to neither confirm nor deny any investigation.
Additionally, a union insurance plan has charged that New York- based Pfizer is improperly marketing Lipitor, costing drug plans billions of dollars in unwarranted prescriptions since 2001.
In a lawsuit filed in federal court, the plan used by Teamsters Local 863 claims that Pfizer has “illegally promoted Lipitor to the public and prescribing physicians by promoting the off-label use of the drug.” Off-label uses are those not approved by the Food and Drug Administration, although doctors are not barred from prescribing drugs for such uses.
Pfizer on Tuesday said it is reviewing the lawsuit.
“Based on the information provided to us, we believe there is absolutely no merit to the claims regarding the promotion of Lipitor,” McCormick said.
The lawsuit, filed Monday in U.S. District Court in Newark, seeks class-action status for drug plans that have covered Lipitor prescriptions.
Pfizer’s marketing of Lipitor misrepresented treatment guidelines of several expert panels, the lawsuit charged.
It noted that although Lipitor got FDA approval in 1996, sales exploded after Pfizer started a campaign to increase awareness among physicians and consumers.
Since then, the FDA has twice cited Pfizer marketing for downplaying Lipitor side effects and the importance of diet and exercise in lowering cholesterol, the lawsuit said.
“Pfizer also employed purported ‘independent’ third-parties, which were fully funded by Pfizer and/or received other incentives from the company, to promote Lipitor’s off-label use,” the lawsuit said.
“These third-parties furthered Pfizer’s scheme by promoting the off-label use of Lipitor to physicians under the guise of providing physicians education information concerning the use of statin drugs.”
Lipitor is in a class of drugs called statins.
Pfizer shares fell 39 cents, or 1.5 percent, to close at $25.42 on the New York Stock Exchange, around the midpoint of its 52-week range of $20.27 to $29.21.