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What is the Right to Try Act and how could it help treat US coronavirus patients?

Right To Try is meant to help patients access new treatments prior to FDA approval but only under certain circumstances

FILE - This Aug. 2, 2018, file photo shows the U.S. Food and Drug Administration building behind FDA logos at a bus stop on the agency's campus in Silver Spring, Md. Health officials reported the first U.S. drug shortage tied to the viral outbreak that is disrupting production in China, but they declined to identify the manufacturer or the product. The Food and Drug Administration said late Thursday, Feb. 27, 2020, that the drug's maker contacted health officials recently about the shortage, which it blamed on a manufacturing issue with the medicine's key ingredient. (AP Photo/Jacquelyn Martin, File) (Jacquelyn Martin, Copyright 2018 The Associated Press. All rights reserved.)

Amid the coronavirus pandemic, the U.S. Food and Drug Administration has been given approval by the president to fast track a vaccine for COVID-19 and look at drugs currently on the market, designed for other illnesses, to treat the virus, however, a law passed in 2018 allows U.S. patients to seek out alternative treatments, it’s called the Right to Try Act.

What is Right to Try? Signed into law in 2018, the Right to Try Act gives more options for treatment to patients who meet these three standards: They have been diagnosed with life-threatening diseases or conditions, tried all approved treatment options and are unable to participate in a clinical trial to access certain unapproved treatments.

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How could it help slow the coronavirus? There are currently several drugs undergoing clinical trials but have not been approved by the FDA yet. Under the Right to Try Act U.S. patients, with the help of their doctors, could possibly try those drugs before they are federally approved for use and distribution in the U.S.

COVID-19 is a highly contagious respiratory illness and it is deadly. As of March 19, there have been more than 9,300 deaths globally associated with the virus, including more than 150 in the U.S.

[MORE COVERAGE: FDA is fast tracking malaria drug to possibly treat coronavirus]

The FDA is also fast tracking a vaccine but it isn’t expected to be ready for at least 12 months, according to FDA Commissioner Dr. Steve Hahn.

On Thursday, during a White House update on the coronavirus President Donald Trump said he has given the FDA more leeway, “better than Right to Try” to look at drugs already approved in the U.S. for other purposes and to develop a vaccine for COVID-19.

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What drugs fall under Right to Try? In order to be considered for Right to Try the drug must have gone through at least a phase 1 clinical trial, hasn’t been approved fro FDA use but an application has been filed or its undergoing a clinical trail intended to support FDA approval. In additon, the drug’s “active development or production is ongoing,” according to the FDA.

Anyone interested in seeking out investigational treatments should speak with their doctor.

To keep up with the latest news on the pandemic, subscribe to News 6′s coronavirus newsletter or go to ClickOrlando.com/coronavirus.


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