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Trump to FDA: Cut the Red Tape to Deploy Drugs to Coronavirus Patients

Trump to FDA: Cut the Red Tape to Deploy Drugs to Coronavirus Patients

Let’s throw away that red tape for good and embrace the private sector.

https://www.youtube.com/watch?v=eFWq6oUI28w

President Donald Trump directed the FDA to cut the red tape to fast-track a few drugs proven around the world to treat the Wuhan coronavirus.

Trump told the media that the administration “slashed red tape to develop vaccines and therapies as fast as it can possibly be done, long before anybody else was even thinking about doing this.”

From The Wall Street Journal:

“Nothing will stand in our way as we pursue any avenue to find what best works against this horrible virus,” Mr. Trump told reporters at a Thursday White House news conference.

Mr. Trump listed drugs used for other purposes that he said might be able to be used in treating the coronavirus.

“If things don’t go as planned, it’s not going to kill anybody,” he said.

Mr. Trump specifically touted drug company Gilead Sciences Inc., and pointed to several drugs, including Hydroxychloroquine and Chloroquine.

Trump mentioned hydroxychloroquine (Plaquenil), an old malaria drug, and treatment for autoimmune disorders.

A study conducted in Marseilles, France, had “encouraging early results” with the drug against coronavirus.

FDA Commissioner Dr. Syephen Hahn said that “a doctor could ask” for an experimental drug that is available. The FDA has “criteria for that and speedy approval.”

How about the government not bring back that red tape? Unfortunately, patients do not have access to drugs because everything has to go through the government.

Let’s look at Olfert Landt, who owns a small-Berlin company:

Founder of a small Berlin-based company, the ponytailed 54-year-old first raced to help German researchers come up with a diagnostic test and then spurred his company to produce and ship more than 1.4 million tests by the end of February for the World Health Organization.

“My wife and I have been working 16 hours a day, seven days a week, ever since,” Landt said by phone about 1 a.m. Friday, Berlin time. “Our days are full.”

By contrast, over the same critical period, U.S. efforts to distribute tests ground nearly to a halt, and the country’s inability to produce them left public health officials with limited means to determine where and how fast the virus was spreading. From mid-January until Feb. 28, fewer than 4,000 tests from the U.S. Centers for Disease Control and Prevention were used out of more 160,000 produced.

Landt said that the U.S. has at least ten companies that could have done what his company did to combat the virus. In other words, the U.S. should embrace the private companies to help in these situations.

Also, why not all the time?

The coronavirus has spread through the U.S. for weeks. Yet, the FDA only approved Roche and Thermo Fisher last week to produce tests.

You guys know I have numerous health issues, mainly three autoimmune disorders. If there is a drug out there could help me combat the disorders you better believe I’d try them out under my doctor’s supervision.

One more thing from the press conference: Surgeon General Dr. Jerome Adams also encouraged young people to donate blood:

“One donation can save up to three lives. Blood centers are opening now and in need of your donation,” Adams said.

He continued: “Blood donation is safe and blood centers are taking extra precautions including spacing beds 6 feet apart and disinfecting surfaces between between patients and temperature checking staffs and encouraging donors making appointments ahead of time so we can space them out.”

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Comments

notamemberofanyorganizedpolicital | March 19, 2020 at 2:25 pm

BRAVO! BRAVO!

The more “red tape” that is cut out, the more the un-elected wannabe dictators in government agencies are put in their proper place.

SpaceInvader | March 19, 2020 at 2:32 pm

My father retired from the FDA 30 years ago and he said it was broken back then. They went from being a agency that kept lead out of toothpaste to being a sledge hammer used by big companies to put small competitors out of business with expensive and burdensome regulations. The big companies had better lawyers than the FDA and knew how to obstruct and derail investigations. They were able to get away with things while small companies would be destroyed by the process.

Bayer donate 3 million tabs for testing and possible treatment

We have to get those test kits out this is a disaster for his administration

“FDA Commissioner Dr. Syephen Hahn said that “a doctor could ask” for an experimental drug that is available. The FDA has “criteria for that and speedy approval.””

What the FDA (or any government agency) considers speedy approval and what the rest of the world considers it to be are completely unrelated.

IOW, this is pure BS.

    Neo in reply to irv. | March 19, 2020 at 3:36 pm

    It might be easier to relabel COVID-19 as malaria

    snopercod in reply to irv. | March 19, 2020 at 3:52 pm

    Yes. Did you catch how the FDA commissioner responded to Trump’s direct order to cut the red tape on hydroxychloroquine? He said, Yes sir, we’ll start a clinical trial right away. So how long will that take – ten years?

      With Trump’s re-election on the line, I bet chloroquine get approved mighty fast, if it is effective. Laura Ingraham’s show this evening had a doctor on, saying it is already being successfully used off label for folks in bad shape from coronavirus. It is also being used in Poland. It has been used for many decades for malaria and is safe.

    puhiawa in reply to irv. | March 19, 2020 at 7:39 pm

    He is lying. The FDA is the EPA of the drug industry. Its sole purpose in being is create a smog of paper work and needless regulations that empower the employees and give them a sense of importance at the cost of countless lives.

Imagine if obama was president now?

– He’d be getting up first thing at 10:30 am.

– He’d be watching television instead of meeting with his security advisors.(Then again, he was soros’ organ grinder monkey, and his attendance wasn’t necessary for the organ grinder’s show)

– he’d be playing golf.

– his transvestite wife would be on another taxpayer funded vacation.

– the Department of Agriculture would be buying more machine guns and bullets.

– hillary clinton would still be looting

– biden would still be looting

– kerry would still be looting

-the sinister valerie jarrett would still be on someone sinister’s payroll

Imagine?

No reason to down vote the call for testing kits
That has been a disaster and continues to be

    Liz in reply to gonzotx. | March 19, 2020 at 4:51 pm

    OK – what specific steps should the administration take to get the test kits out?

    I’m seeing a lot of red tape being cut and there are valid criticisms of the federal & state bureaucracies, but there are a lot of companies taking the challenge to develop and distribute the tests.

the problem isn’t that they haven’t been thru human trials, they have just for other diseases, they want to use them for ‘off book’ as I believe is called(diseases they weren’t originally designed for)

    amwick in reply to ronk. | March 19, 2020 at 4:33 pm

    I thought there was a test in France.. I guess that doesn’t count here?

    And then my fellow Americans will go back to their usual behavior because a treatment exists. On the bright side, toilet paper will return to supermarket shelves.

    Lucifer Morningstar in reply to ronk. | March 19, 2020 at 11:19 pm

    The phrase you’re looking for is “off label”. And if hydroxychloroquine has been shown to be even the least bit effective in assisting victims sorry, patients, in recovering from Wuhan virus then states need to start buying it in quantity and start using it on the worst hit patient first and work their way down to ladder to the least if necessary.

they need to make them available over the counter, I could swear that quinine in some form was available with out a script

    Liz in reply to ronk. | March 19, 2020 at 5:03 pm

    I’ll drink to that…

    Actually, I was getting various tonic syrups online and testing them out. And some of them are pretty good to mix with soda stream. (oh no – I only have one spare gas canister). My last blood work had one test that was elevated, though we think it was a combo of items.

    So beware of quinine, though you would have to drink a couple liters of tonic water a day. My potential issue was that I was making a stronger tonic water that what you can get in the grocery store.

Testing is still a challenge. Per a front page LA Times story, the husband of the first death in LA County, was denied testing, since he did not show enough symptoms.

Front page LA Times per my Mother. I have not figured out the LA Times link, but found this:
https://news.mb.com.ph/2020/03/19/filipino-is-1st-covid-19-fatality-in-los-angeles/

Exactly
It’s almost impossible to get tested And that is a major problem if people want to believe it or not!

notamemberofanyorganizedpolicital | March 19, 2020 at 7:15 pm

RUT ROH!!!!!!!!!!!!!!!!!!

Former FEMA Administrator Craig Fugate just walked off MSNBC:

“I don’t have time to listen to bullshit people.”

A friend asks, stunned: “Is this what ‘journalists’ actually think they’re doing? Fighting coronavirus?”

Is that what they think they’re doing when they ask the 100th question about whether calling a Chinese virus the Chinese virus is racist? Do they think those questions are synthesizing a vaccine?

I would actually imagine the answers are “yes:” The press corps actually does believe that if they cover the law, they’re lawyers. If they cover technology, they’re engineers. And if they cover an epidemic, they’re front-line medical personnel with notebooks and pocket audio records.

They really are that delusional.

http://acecomments.mu.nu/?post=386417

notamemberofanyorganizedpolicital | March 19, 2020 at 7:15 pm

The faces made in the room as @ChanelRion

asks Trump: Is it alarming that major media players…are consistently siding with a foreign state propaganda, Islamic radicals, and Latin gangs and cartels and they work right here…with direct access to you and your team?

https://twitter.com/Julio_Rosas11/status/1240682224032321542

One of the obvious ways to cut down on the FDAs ridiculous approval process is to allow probationary approval for drugs that were passed for safety and effect by other trusted international agencies or perhaps 2 of such. For example the 3 most trustworthy agencies outside of the USA are the Swiss, the EU and Japan. If a drug is approved by any 2 of these, it should be given immediate probationary approval in the US.

One of the obvious ways to cut down on the FDAs ridiculous approval process is to allow probationary approval for drugs that were passed for safety and effect by other trusted international agencies or perhaps 2 of such. For example the 3 most trustworthy agencies outside of the USA are the Swiss, the EU and Japan. If a drug is approved by any 2 of these, it should be given immediate probationary approval in the US.

And how long after “cutting the red tape” and getting these drugs to people before the first “If you’ve been injured by a coronavirus drug…” commercial shows up from some trial lawyers group trolling for clients?

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