Posted on 03/25/2020 7:30:59 AM PDT by karpov
Entrepreneur Elon Musk, President Donald Trump, and New York’s Governor Andrew Cuomo have each touted chloroquine, a drug used to treat malaria, as a promising treatment option for those infected with Covid-19. Some media quickly pounced on the president’s statement. The commissioner of the Food and Drug Administration, Stephen Hahn, quickly clarified that the agency had not in fact approved the drug as a safe and effective treatment for the new disease, shortly after the president claimed that the drug was “approved very, very quickly and it’s now approved by prescription.”
Chloroquine is in fact available for prescription in the United States. It’s already being tried as a treatment for the new virus in U.S. hospitals. And multiple manufacturers are rushing to produce more and get it to doctors.
The confusion over chloroquine—along with the broader performance of U.S. regulatory agencies during this epidemic—highlights how our federal process for reviewing and approving drugs and medical devices still leaves much to be desired. Our regulatory regime is costing lives. The early administrative failings of the FDA and Centers for Disease Control, which greatly worsened the crisis in the United States, show how ugly that can be.
Getting a new pharmaceutical compound to market in the U.S. is an extraordinarily complex process. Development time is usually more than a decade. Costs add up to hundreds of millions, if not billions, of dollars. After an innovator submits an Investigational New Drug application, the FDA requires a three-stage testing process, then the submission of a formal New Drug Application that typically includes hundreds of thousands of pages of documentation.
However, once the FDA has approved a pharmaceutical compound as safe and effective for a particular use, doctors can prescribe the drug for an alternative use
(Excerpt) Read more at city-journal.org ...
I posted this on another thread, I hope you don’t mind my reposting it here:
Since day one of his Administration, President Trump has been consistent on this point: If a drug has been deemed safe for human consumption under the care of a doctor, that doctor should be allowed to administer it to people without the FDA having to approve it for that use.
He has been touting the “right-to-try” since his 2018 State of The Union address and even before, and this should be even less controversial.
If a drug has been deemed safe for human consumption, the FDA should not be an obstacle to use in “off label” situations under a doctor’s care, although I am sure there are likely exceptions to this.
How the FDA got into efficacy versus safety over the years is likely a long story...but it has become a roadblock to finding uses for approved drugs.
Fauci gave us a mixed message on this....never mentioning alternative use. AND we know these compounds are being used effectively and successfully.
Yes! Thank you for posting this.
This is a REAL opportunity to preach conservatism.
Big bloated government will quite literally GET YOU KILLED.
Just imagine if anyone other than Trump had been POTUS and the bureaucracy had been allowed to continue fumbling along in its usual manner. Trump’s ass-kicking has saved tens of thousands of lives. That plus any of the REAL solutions here are coming from the private sector.
We give the CDC $8 billion a year to keep tabs on stuff like this and they dropped the ball completely. There are even reports that they were lying to Alex Azar when the situation started to get severe.
The FDA stands for Foot Dragging Administration. Whenever someone asks them why it takes so long to approve new drugs, they point back to the thalidomide disaster of the early 60s where Europe quickly approved thalidomide to pregnant women who later gave birth to children with severe birth defects. And the ONLY reason the US dodged that bullet was literally because of foot dragging and bureaucratic red tape by the FDA, not because of an abundance of caution.
Since then they have followed the foot dragging model on EVERY new drug, costing millions of lives and driving the cost of developing new drugs to unprecedented levels.
An excellent article that accurately explains the current situation WRT Covid-19. Thanks for posting.
Government employees...just a job to them. Might as well be working in a grocery store.
Leadership at CDC should be fired.
When it became apparent that tests were needed FDA insisted that only CDC design and approved test could be used. Even though private labs and university labs had developed their own tests for Covid19. FDA ordered those labs to stand down and do no testing.
Then the CDC sent out tests that DID NOT WORK and had to recall them. Still the CDC would not allow other labs to test or develop test kits. Finally when the need for tests was overwhelming CDC/FDA allow private labs to test.
We lost many weeks to Covid19 due to INCOMPETENCE at CDC which was more interest in protecting it turf than protecting the American people.
I am amazed the director of CDC is still employed. Dido FDA.
God I hate urinalists!
This article is misleading and full of LIES!
“the agency had not in fact approved the drug as a safe and effective treatment for the new disease,”
HALF true. let me fix it...
the agency has in fact approved the drug as a safe and effective treatment for disease,
“multiple manufacturers are rushing to produce more and get it to doctors.”
Almost true...
multiple manufacturers have ALREADY produced more and have ALREADY shipped it to doctors.
“Getting a new pharmaceutical compound to market in the U.S. is an extraordinarily complex process”
IRRELEVANT. This is NOT NEW! It is VERY OLD! IT has been used for DECADES!
The truth, the WHOLE truth, nothing but the TRUTH, so help you, GOD.
“He has been touting the “right-to-try” since his 2018 State of The Union address and even before, and this should be even less controversial.”
I thought the “right to try” law has already passed. What’s the controversy all about?
This is related to “right-to-try” in concept, the FDA “efficacy” job they somehow acquired over the years. That is, even if something in the drug world is deemed safe for human consumption, the FDA will not grant any kind of approval for use with any other condition without a trial.
Another layer of bureaucracy. In my opinion (And Trump feels this way too, the “right-to_try is an philosophical extension of that) if a physician has a patient under their care, and they wish to use a previously approved safe drug to treat a condition, they should be allowed to use it for other purposes. If they harm the patient because they gave them a safe drug when they should have received some other kind of drug, that is malpractice and there are avenues to handle that.
I could be wrong on this, but the “right-to-try” is a bit different and applies only to terminally ill patients IIRC.
Certain groups like elderly, pregnant etc...need to be handled in groups apart from the relatively healthy. It is a shame CDC is not more efficient.
it’s probably one step up from baking soda.
Hope & pray USA can access a supply line. There was a W. VA. facility that was going to start cranking up on this that had in the past produced HCQ & was going to start again.
I would like daily reports on this with reporters standing outside that plant.
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