Observations

The Food and Drug Administration frequently finds itself in the position of needing to make public health policy decisions 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. FDA has a smart staff with unique skills and viewpoints. Future issues will bring you some of their stories and accomplishments.

The current issue contains plenty of examples of how FDA balances the risks and the benefits of medical products. For example, FDA recently approved the use of saline-filled breast implants. While the agency deemed them safe to use, it gathered considerable information about the side effects that a user can expect.

Pharmacy compounding is another risk/benefit balance. On one hand, this practice of customizing prescription pharmaceuticals in a private drug store can, for example, avoid problems with allergies to certain ingredients. But it also increases the risk of poor manufacturing controls. Only a well-informed consumer can make a well-considered decision about using this option.

I don't want you to get the impression that everything FDA does has a level of uncertainty. When dangerous problems arise, as in the medical gas industry, or when manufacturers make unsupported claims about a medical device as described in the Investigators' Report, the agency knows exactly what to do--and does it.

FDA remains a dynamic agency with a diverse portfolio of problems and challenges. And that makes for interesting stories.

Oh, and remember: Keep those cards and e-mails coming. Let us know how we are doing. If you have a story idea you think the magazine should consider--or an FDA staffer's story you think we should tell--send it along to the Letters to the Editor e-mail address, FDAC-letters@oc.fda.gov. We're always looking for ways to make this the most interesting magazine you read.

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