WASHINGTON -- Safety concerns raised by a 1992 Food and Drug Administration probe of Upjohn Co. and its sleeping pill Halcion should have been brought to the Justice Department for further investigation, an FDA task force has concluded.
The task force found no evidence that Halcion is unsafe when taken as directed. Nor did it cite any evidence of criminal wrongdoing by Upjohn. But it said the FDA should have pressed more vigorously to see if Upjohn had hidden or falsified any data.
In its own review, the task force found that Upjohn had exercised poor oversight of some clinical tests used to win the FDA's approval in 1982 to put Halcion on the market.
"Further inquiry into allegations of criminal misconduct by Upjohn is most appropriately the subject of consideration by the Department of Justice," the FDA task force report said. Kaye Hooker, a spokeswoman for the U.S. attorney with jurisdiction in Upjohn's home state of Michigan, said yesterday that the new FDA task force report is under review.
Underreported psychiatric side effects in an early Halcion study on inmates at a Michigan prison could have affected the FDA's decision to approve the drug, the task force said.
While the FDA's approval of Halcion might have been unaffected by the disputed data, the task force said, the reporting errors were "material" to the agency's deliberations.
Halcion was once the world's top-selling sleeping pill. But the controversy over its potential side effects and the availability of other products caused Halcion prescriptions to drop 67 percent between 1987 and 1992, the FDA said. In part because of the allegations about the faulty data in the prisoner study, Britain banned sales of the drug in 1991.
Because of the lingering questions, the FDA said yesterday that it will ask outside scientific experts to re-evaluate the drug. There have been several reviews previously, including one in 1992 at which Upjohn submitted corrected data on the disputed study. At that time, the FDA lowered the recommended dose, `f toughened the warning label and restricted the number of pills per package.
"We stand behind Halcion and we are convinced that yet another assessment of it will confirm what the (FDA) and its advisory committees have concluded for years: Halcion is safe and effective when used as recommended," the company, now known as Pharmacia & Upjohn Inc., said yesterday.
The FDA task force was formed in 1994 to look into the agency's 1992 field investigation of Upjohn and Halcion. That investigation claimed the company had shown "an ongoing pattern of misconduct" in its Halcion studies, and the chief FDA investigator complained that he had been ordered by higher-ups to end the probe.
Public Citizen, a consumer health group, complained about a possible "high-level FDA cover-up" of the agency's handling of Halcion. The task force said it found no evidence of criminal misconduct or malfeasance by FDA employees. It also said the FDA field report had included conjecture and unsubstantiated allegations against Upjohn.
Dr. Sidney Wolfe of Public Citizen criticized the task force report as a "whitewash" that passed the question of Halcion's safety on to yet another advisory group.