Trump Calling Out Fda's Painfully Long Process In His Address To Congress

chemicalbrother

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I'm still watching but wanted to say here that Trump just "attacked" the FDA head on by stating that the procedures to get meds to market are far too cumbersome and he wants to "speed up" the process.

This is my loose memory of what he said
If someone has the entire accurate transcript be sure to post it here.

edit:
Rewatched and typed out transcript (this is literally what he said , safe from some spelling errors)

Setup: Girl in wheelchair by the name of Megan in the room, survived very rare disease thanks to dad taking matters into his own hands - funding medicine. Girl is now 20 years old , far beyond her life expectancy.

Trump : "... but our slow and burdensome approval process at the FDA keeps too many advances, like the one that saved Megan's life, from reaching those in need.
If we slash the restraints, not just at the FDA, but across the government, then we will be blessed with far more miracles, just like Megan"


Standing ovation of Republicans, most dems stay seated.
 
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Captain Rex

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this one?
http://www.raps.org/Regulatory-Focu...latory-Policy-May-Apply-to-Some-FDA-Guidance/

but it didn't work because
does not seem to include FDA guidance for industry.

so, they issued a new executive order especially for FDA.
http://www.raps.org/Regulatory-Focu...s-Regulations-Again-With-New-Executive-Order/

According to the order signed on Friday, each federal agency’s Regulatory Reform Task Force shall evaluate existing regulations and make recommendations to the agency head regarding their repeal, replacement or modification, consistent with applicable law.

At a minimum, according to the order, each Regulatory Reform Task Force shall attempt to identify regulations that:
(i) eliminate jobs, or inhibit job creation;
(ii) are outdated, unnecessary, or ineffective;
(iii) impose costs that exceed benefits;
(iv) create a serious inconsistency or otherwise interfere with regulatory reform initiatives and policies;
(v) are inconsistent with the requirements of section 515 of the Treasury and General Government Appropriations Act, 2001 (44 U.S.C. 3516 note), or the guidance issued pursuant to that provision, in particular those regulations that rely in whole or in part on data, information, or methods that are not publicly available or that are insufficiently transparent to meet the standard for reproducibility; or
(vi) derive from or implement Executive Orders or other Presidential directives that have been subsequently rescinded or substantially modified.

- See more at: http://www.raps.org/Regulatory-Focu...ith-New-Executive-Order/#sthash.M3Qoh70y.dpuf

hardly mentions anything about speeding up clinical trials.
 

Captain Rex

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Trump : "... but our slow and burdensome approval process at the FDA keeps too many advances, like the one that saved Megan's life, from reaching those in need.
If we slash the restraints, not just at the FDA, but across the government, then we will be blessed with far more miracles, just like Megan"
Well said but the thing is he says a lot of things but does a little.
I hope I am wrong in this case.
 

cyrusthegreat@hotmail.com

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I'm just glad this is being discussed at such a high level and so publicly. The fda approval process is very important and needed, but it's far from efficient.
 

donsf448

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Trumps one of us man. He's on propecia. I'm sure he wants them to approve Brotzu or Follica so he can hop on something less impactful on the hormones.
 

resu

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This is what I like about Trump, can you imagine Hillary or Obama saying Sweden is a mess? Or even mention how slow the FDA is?
 

lemoncloak

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worm

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Im the furthest thing from a trump lover, however he does make some valid points. One of them is that it is unnecessarily expensive to develop meds, which I agree impede some potentially life saving pharmaceutical developments. For that reason no one is working on new antibiotics since they expire quickly and dont pay off the money invested.

But as @Pigeon said, it is a double edged sword, what if rushing meds to market has bad outcomes as well. Just look at Vioxx.

That said, there must be a way to reduce the costs to encourage innovation.
 

hellouser

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That said, there must be a way to reduce the costs to encourage innovation.

Take your business out of America.

Watch how quickly politicians scramble for reform cuz you know they wont be getting that morally right bribery donor money.
 
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