Trump nudges FDA for fast-track treatments of COVID-19, but the wait may be longer

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President Donald Trump has pushed the Foods and also Drug Administration (FDA) and urged upon them to remove barriers for delivering therapeutics for coronavirus to patients. Trump told reporters at the White House that it has been a long time around, and if things do not happen as planned, nobody would be killed by it. He emphasized the need to remove every barrier or, more correctly, a lot of unnecessary obstacles and also the FDA has done that to ensure rapid deployment of safe, effective treatments. The President firmly believes that we have some good answers.

The FDA’s stand

FDA Commissioner Stephen Hahn came out to explain the President’s remarks in a more tempered way about his team’s work to develop treatments for coronavirus. He highlighted the FDA’s commitment to keeping providing regulatory flexibility and also guidance but made one thing clear that the FDA is to the American people by expanding its work regarding potential therapeutic options.

Hahn emphasized the need to ensure that every patient gets the right drug of the correct dosage and at the right time. He clarified further that even if the right drug was available, it might not be in the proper dosage, which can do more harm than good.  

Exploring already approved drugs for treating coronavirus

Noting the President’s remark on chloroquine, Hahn said that exploring the possibility of using drugs already approved for other indications would be a part of the exercise. The President has directed the FDA to have a closer look at whether hydroxychloroquine could be useful for treating coronavirus and if it is beneficial for patients. Hahn confirmed of doing it in the setting of a clinical trial, large and pragmatic, to gather extensive information.

Last month, when asked about chloroquine, Dr. Janet Diaz of the World Health Organization had said there is no at this time that it is effective in treating coronavirus patients. WHO recommends testing of therapeutics under ethically approved clinical trials to show safety and efficacy.

Hahn also explained the process of convalescent plasma that involves isolating blood from the survivors of the coronavirus patients and also have the right immunoglobulins.

The timeline

Regarding the timeline for the exercise, Hahn said that more information was expected within the next couple of weeks, and also they accelerate. This should bridge with other therapies that could take 3-6 months to develop. He reiterated that it was a continuous process without any beginning and end. Talking about the vaccine trial that is underway, he said that it should take 12 months.

According to Dr. Sanjay Gupta, Chief Medical Correspondent of CNN, there is nothing wrong with being hopeful. But it needs exerting a bit of caution, especially for the drugs under discussion. They must go through trials like any drugs so that it does not raise false hopes.

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