A Legal Look at the Drugs Being Used to Potentially Treat Coronavirus

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The Trump administration said Thursday that the Food and Drug Administration cleared two antivirals from Gilead Sciences GILD to battle symptoms of coronavirus.

 The drugs are remdesivir and hydroxycholoroquine, which goes by the brand name Plaquenil.

Gilead refers to Remdesivir as "experimental" and "not approved anywhere for global use."

But the FDA has emergency protocols in place that have fast-tracked the treatment, and it is available through the FDA's "compassionate use" rules. The drug has not been officially cleared by the FDA for marketing.

So, when the Trump administration says that it's cut the FDA's red tape to get the drugs approved in a timely matter, what kind of legal issues does that bring up?

Rebecca Rose Woodland, litigator and legal analyst, joined TheStreet to break it all down for investors.

Watch the video above for more.

Video Transcript:

Katherine Ross:
There's all this focus, particularly from this administration, on chasing vaccines, but there are already drugs that exist that some doctors are saying could be effective in treating the coronavirus. Joining me to break down what you need to know from a legal perspective, is Rebecca Rose Woodland, litigator and legal analyst. Rebecca, these drugs, particularly the malaria drugs, are in massive production already, so why aren't they being used in the U.S. to treat the coronavirus?

Rebecca Rose Woodland:
These are great questions, Katherine. I think what we're seeing here is a bit of push and pull. The president has heard, apparently according to a press conference he had yesterday, that the malaria drugs could be effective. The president now, from what I understand, is pushing forward very heavily on some of the manufacturers of that malaria drug in the United States, to increase output. He's doing that because he believes he has the right to have doctors use that, although the drug was approved for treatment in malaria, also now to use in treatment against the coronavirus.

Rebecca Rose Woodland:
The head of the FDA has said, "Well, we'd like some more trial testing." Now, the way I look at it is a couple of things. The FDA is under the executive branch of government, the president. Therefore, I think the president can order the FDA, fast track the use of this, override that need to have these extensive clinical trials for a new use. And I also think if you look at a bill that the president signed into law in 2018, it was called the Right to Try bill, AND that bill had to do with experimental medicines that weren't fully fledged out or fully FDA approved, that people who were on course of dying, had some sort of illness that was threatening their life, could use these experimental drugs.

Rebecca Rose Woodland:
I would argue that possibly the president could apply that law that's already been signed into law. Both branches of the government have approved it in the federal government, and then the president signed it into law, that that right to try law could apply to these drugs that we're seeing really, in a very quick basis might help people survive this coronavirus. If that's the case, let's use them. Let's use these malaria, anti-malaria drugs. Let's use these other viral, antiviral drugs to help people on an emergency basis. We don't have time for the clinical trials. We have to move quickly, and have these people stay alive with the use of these possible drugs that have already been in use for years.

Katherine Ross:
But of course, there's always protocols to follow. So I'm wondering what kind of protocols do these doctors who want to use these drugs have to follow?

Rebecca Rose Woodland:
So that's another interesting thought. What are the protocols? Now, there are some different laws on that too. It seems like if the drug is already in use for one purpose, that a doctor in an emergency situation can apply it to another purpose, if he feels that it would help someone survive. The protocols also could be that the FDA very quickly issues a statement allowing the use of these drugs in coronavirus patients, or the president comes forward with an executive order overriding any potential issue, and ordering that these anti-malaria drugs, these antiviral drugs that have already been approved for malaria, can be approved and used for the coronavirus patients that are really facing very dire circumstances.

Katherine Ross:
Rebecca, thank you so much for joining us today, and for all of your legal insight. And guys, of course, head on over to thestreet.com for more on the coronavirus.

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