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As the White House struggles to address the pandemic and other pressing health matters, a public tug-of-war has emerged over who should be tapped to run the Food and Drug Administration.

In recent weeks, competing missives have been issued urging the Biden administration to choose either Janet Woodcock, a long-standing FDA official who some perceive to be unnecessarily sympathetic to industry, or Joshua Sharfstein, who has also served at the agency and has a public health background, but is seen as less supportive of industry concerns.

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  • This is really a tough choice. I’ve admired Janet Woodcock’s long drive to get drug companies to use regulatory science in drug development and she’s been instrumental in developing the principles of that regulatory science. But I don’t have any details on what she was doing during Trump’s reign, and that’s important to know. FDA has really lost a great deal of credibility. The numbers of people who are resisting COVID-19 vaccination proof of that. I’m also concerned about all the great people at FDA who have had to endure the Trump years. Who is best able to restore their morale? Whoever leads it must be able to show that a new broom sweeps clean, so I lean toward Dr. Sharfstein. FDA is above all the the agency that safeguards public health. I wonder if the agency doesn’t need an Inspector General role to help assess the health of FDA itself.

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