Regulations and off-label drug use

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Walker
Posts: 14353
Joined: Thu Nov 05, 2015 12:00 am

Regulations and off-label drug use

Post by Walker »

The affirmative: Expediency

“Soon after taking office Trump began pushing to allow the “off-label” use of medications to treat the seriously and terminally ill where their physicians saw potential benefit and getting congressional approval for the FDA to allow that was a significant milestone. Now, in the face of the Wuhan virus, he has raised the pressure on the FDA to act with lightning speed, specifically directing the FDA to suspend any rule that was causing delay. We have seen significant results. One was when a German company offered a new test showing if a patient was infected. The normal review procedure took a minimum of six weeks, but the application was approved in just three hours. When limited testing showed that chloroquine, a drug used to treat and cure malaria, was effective against the COVID-19 virus, Trump directed that the FDA move forward “with all possible speed” to conduct human testing and determine the larger-scale effectiveness of the drug. Within hours drug maker Bayer announced they were donating a million tablets to the effort to contain and cure the virus.

“Such results show the measure of the man leading our nation’s efforts to battle and defeat the Wuhan virus. So we should be thankful in this trying time that we have a fast-moving CEO as President instead of a snail-speed bureaucrat.”

https://www.americanthinker.com/article ... speed.html

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The negative: Caution

How U.S. regulation prevented off-label use of a drug and a subsequent birth defect disaster
https://www.motleyrice.com/blogpost/off ... t-disaster


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