America's trust in the FDA

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In America, whenever you open a medicine bottle, put a pill in your mouth and swallow, you're engaging in an act of trust. It's the promise that, thanks to the men and women of the Food and Drug Administration, there's been a rigorous examination of how safe and effective it is. 

That trust isn't to be taken for granted.

Now, instead, imagine a world where you open that bottle, take out the pill, and before you put it on your tongue, you pause. You question whether you should, because you don't trust the political party that was in power when it was approved. 

The FDA headquarters.

Photographer: Stefani Reynolds/Bloomberg

Let's not be naive. Medicine has never been exempt from politics, and neither has the FDA. But even when the politics of the moment focused on the agency, for example during debates about birth control, there has almost never been the real worry that crucial 

decisions about approving or rejecting drugs could be strongly influenced by political considerations

If you're cynical enough, it's a possibility. What president wouldn't want to see a drug for Alzheimer's disease approved on his or her watch? Or, for that matter, a drug or vaccine that could end a deadly pandemic?

A crucial role of the head of the FDA is to protect the agency's independence. That doesn't mean ignoring the outside worldfor example, by systematically speeding review of potentially breakthrough cancer drugs. But, as current FDA Commissioner Stephen Hahn said in an interview with Bloomberg, it means making consistent decisions based on science, even when the outside pressure is immense.

Hahn badly erred in a press conference Sunday with the current president, making a misstatement about the effectiveness of an experimental Covid-19 therapy. "I made a mistake," Hahn said in Tuesday's interview. 

How he leads the agency in the coming months, and whether Americans trust it in the years to come, will be shaped by the decisions the FDA makes about drugs and vaccines in the middle of the pandemic. —Drew Armstrong 

 

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