Magazine article FDA Consumer

Observations

Magazine article FDA Consumer

Observations

Article excerpt

The Food and Drug Administration frequently finds itself in the position of needing to make a public health policy decision even as it struggles with insufficient scientific information. Often, there is enough data to spot some of the dangers but not always enough to easily chart the safest course.

This theme--balancing the knowns and the unknowns of science with the need to regulate--runs throughout FDA's history. It's a challenge as old as the 40th anniversary of the Pill, the first medication approved for use in healthy people, that's recounted in the commentary on this issue's last page. And it's as contemporary as the cover story on current dilemmas about the best formulations and labels for sunscreens.

While debates are common within the agency, the public seldom hears much about FDA's deliberations until after the decision is made. Only then is there a notice in the Federal Register, and maybe a Talk Paper or Backgrounder. Sometimes the media pick up the story, sometimes not. Trying to understand a particular issue is often like following a baseball team's season when you only hear about an occasional score long after the game is over. You miss the drama of the competition in progress. Moreover, if you don't hear another score for several games, it's tough to know where the team places in the standings. Are they up; are they down? You can't tell. That kind of reporting makes it awfully difficult to follow the team--or a public health issue.

FDA Consumer won't report on the incremental advance of every important public health problem in every issue. But it will try to spend more time talking about work in progress. And that should make for interesting reading. Frequently, the story behind the outcome is as compelling and fascinating as the decision itself.

So, future issues of FDA Consumer will try to pull back the curtain a bit and look at the process, not to reveal the bureaucratic machinations, but rather the very real human drama in which highly trained experts struggle with complicated information that has a profound impact on the public. …

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