FBI investigators have been interviewing Food and Drug Administration employees involved in the agency's 1996 decision to approve American Home Products' Redux diet drug, The Wall Street Journal said. Redux and Pondimin, another diet pill also sold by AHP, were both pulled from the market in 1997 after being linked to heart-valve problems.
AHP, meanwhile, denied any knowledge of an investigation and maintained there was no basis for a probe.
In a statement, AHP senior vice president and general counsel Louis Hoynes said the company was "absolutely unaware" of any investigation by the Justice Department or the FBI related to diet drugs.
"We know of no basis for such an investigation, and we are confident that American Home Products' actions with respect to Pondimin and Redux were at all times lawful and appropriate," Hoynes said.
The Journal, citing an unidentified FBI agent and another person familiar with the matter, said investigators were probing whether AHP and other companies involved revealed all they know about possible adverse reactions to the drugs to the FDA. The FBI also is examining the deliberations of an FDA advisory committee that recommended Redux's approval, the report said.
While the FDA was deliberating approval of Redux, AHP served as an adviser to Interneuron Pharmaceuticals Inc., which held the U.S. rights to Redux and had partnered with AHP's Wyeth-Ayerst Laboratories to produce and market the drug.
An Interneuron spokesman told the Journal the company had not been contacted by the FBI.
Investigators also want to determine whether there is enough evidence to prompt a formal criminal inquiry, the report said.
AHP is the subject of several civil lawsuits by patients who used the diet pills. More than 6 million U.S. patients took Redux or the closely related Pondimin during the 1990s. Redux, known by the chemical name dexfenfluramine, was often prescribed with another drug, phentermine, in a combination known as "fen-phen."
Written By William L. Watts