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Dr. Marty Makary: The FDA needs new leadership

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13.10.2021

Paul Gigot interviews Dr. Marty Makary

COVID has given us a clear-eyed look at a broken Food and Drug Administration that’s mired in politics and red tape.

Americans can now see why medical advances often move at turtle speed. We need fresh leadership at the FDA to change the culture at the agency and promote scientific advancement, not hinder it.

This starts at the top. Our public health leaders have become too be accepting of the bureaucratic processes that would outrage a fresh eye. For example, last week the antiviral pill Molnupiravir was found to cut COVID hospitalizations in half and, remarkably, no one who got the drug died.

The irony is that Molnupiravir was developed a year ago. Do the math on the number of lives that could have been saved if health officials would have moved fast, allowing rolling trials with an evaluation of each infection and adverse event in real-time. Instead, we have a process that resembles a 7-part college application for each of the phase 1, 2, and 3 clinical trials.

DR. MARTY MAKARY: I HAVE MEDICAL CONCERNS AROUND BIDEN'S NEW VACCINE MANDATES

The FDA is now in receipt of Molnupiravir’ application for an EUA, which the agency will ponder for the next two to three months. Authorization of this life-saving drug is expected just when the last Covid wave will be over. We can’t use peacetime processes in a time of war.

For too long, FDA leaders have acted like a crusty librarian who gets annoyed when someone wants to borrow a book. But then give preference to people they like.

For example, why hasn’t the FDA granted an emergency use authorization for the Oxford/AstraZeneca vaccine? The U.K. approved it last year and more than a billion doses have been delivered worldwide. We badly needed........

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