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FBI investigates Redux
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September 8, 1999: 11:45 p.m. ET
Inquiry focuses on whether company knew, but hid, dangers of diet drugs
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NEW YORK (CNNfn) - The Federal Bureau of Investigation has launched an inquiry into how American Home Products Corp. won regulatory approval for a controversial diet drug, according to a newspaper report.
The Wall Street Journal's interactive edition late Wednesday reported that FBI agents are interviewing employees of the U.S. Food and Drug Administration about the 1996 decision to approve the use of Redux. That drug, along with another AHP diet drug called Pondimin, made up the combination known as "fen-phen." Both drugs were pulled from shelves in 1997 after they were linked to heart-valve problems.
According to the Journal, the FBI is investigating whether AHP knew about the possible health risks of using Redux, but failed to tell FDA regulators.
No decision has been made yet about whether there will be a formal criminal inquiry, the Journal said, citing an unidentified federal agent.
FBI and FDA officials would not confirm or comment on the investigation to the Journal.
When it rains, it pours
Word of the investigation comes at a difficult time for American Home Products (AHP).
In August, a federal judge in Philadelphia granted class-action status to a lawsuit filed by former users of the "fen-phen" diet combination who want AHP to pay for their medical checkups.
Also in August, a Texas jury awarded a former fen-phen user $23.3 million in damages for heart problems. It was the first jury award stemming from individual fen-phen cases, although the Madison, N.J.-based drugmaker has disclosed settling about 20 such cases out of court.
AHP's Wyeth-Ayerst Laboratories division also agreed recently to settle claims by about 36,000 women who said they were injured by the company's Norplant birth control device.
The company responds
In a statement released to The Associated Press Wednesday evening, AHP senior vice president and general counsel Louis Hoynes said the company was "absolutely unaware of any investigation by the U.S. Department of Justice or the Federal Bureau of Investigation relating to diet drugs."
Hoynes said the company knew of "no such basis for such an investigation and we are confident that American Home Products' actions concerning Pondmin and Redux were lawful and appropriate."
Responding to the Journal report, AHP attorney Marc Farley said such preliminary investigations often lead nowhere and should be private.
"Agents can look into anything," said Farley, a former assistant U.S. attorney who worked on health fraud cases for several years. "I just think it's very unfair to anybody -- whether it's a company or an individual -- to have this kind of (public) exposure when law enforcement is looking at them in a preliminary capacity without the need for showing any probable cause." 
-- from staff and wire reports
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American Home Products
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