F.D.A.’s Secret Files

The Food and Drug Administration has created a task force to recommend ways to reveal more information about how the agency makes decisions about the safety and efficacy of drugs and medical devices. Any move in the direction of greater transparency is bound to help both patients and their doctors better understand the risks and benefits they face.

At the insistence of industry, and its claims of proprietary information, the F.D.A. often sits on data that raise questions about a drug’s safety or therapeutic value. The consequences for some patients can be severe.

As Gardiner Harris reported in The Times on Tuesday, in recent years, the F.D.A. failed to inform the public that a widely prescribed heartburn drug was especially toxic to babies, that a diabetes drug and a painkiller increased heart attack risks and that antidepressants increased suicidal thoughts and behavior in youngsters.

The agency is hemmed in by laws restricting its ability to release trade secrets and internal agency records. But there seems little doubt that it has been overly cautious and that public safety has suffered as a result.

http://www.nytimes.com/2009/06/03/opinion/03weds2.html?th&emc=th

I am sure there is a reason for in a very very very tiny amount of cases, but why Rx a heartburn drug to a baby?