Critic: FDA withholding data on controversial sleeping pill

May 23, 1996
Web posted at: 11 p.m. EDT

From Correspondent Jeff Levine

WASHINGTON (CNN) -- Is the sleeping pill Halcion safe? The question simply won't rest. Two years ago Congress asked the Food and Drug Administration to issue its report on the drug's safety, but the FDA has yet to act.

"We've given them until the end of May to either give us the documents or the report," said Rep. Joe Barton, R-Texas. "We're led to believe now that they may actually comply with that request."

Barton is a vocal critic of the FDA.

The agency declined to comment on the pending report.

There are lingering concerns that Halcion can make people suicidal or homicidal, although millions still take it.

"I have not seen, in the use of Halcion, or other medications in this category, both in my practice or in the literature, a significant association with murder, mayhem, suicide," said Dr. Brian Doyle of Georgetown Medical Center.

Still, the British government pulled the pill off the market in 1991. In the United States the following year, Halcion passed an FDA safety review.

The advocacy group Public Citizen says the drug should be banned and that the manufacturer deliberately misled federal officials about its safety.

"The failure to criminally prosecute Upjohn sends a signal to the rest of the drug industry that you can get away with criminal behavior ... because the FDA isn't going to do anything about it," said Dr. Sidney Wolfe, of Public Citizen's Health Research Group.

Pharmacia & Upjohn denies the charge. "We have cooperated to the best of our ability with FDA requests regarding Halcion," a statement from the company says.

Barton says cooperation is essential in the dispute, and the FDA should have been more responsive to questions from his staff. "Some folks in the FDA just wished this issue would go away and did not really want to complete or conduct this investigation in a timely fashion."

Critics say the FDA may be dragging its heels on the report because it could show agency scientists erred by approving the drug. Pharmacia & Upjohn officials say they are standing by Halcion and are eager to get the investigation concluded.

Related sites:

• Halcion information
• Food and Drug Administration
• Public Citizen

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