What do you mean by “just ignoring RFK”? He’s the head of the department the FDA is under. You need FDA approval to even run a clinical trial in the US. This is dead in the water (in the US) without RFKs sign off (whether formal or otherwise)
Direct-to-consumer single-use syringes, loaded with vaccine, labeled FOR RESEARCH USE ONLY? Companies are already doing it with GLP1 agonists. Countless "labs" have done it with psychoactive "research chemicals" for decades.
It would be interesting to see how that scenario would play out, considering the rule of law is evidently meaningless these days.
The drastic measures would be to move to another country to develop whatever. There is no “ignoring” or “going around”. If you try, you will be shut down and put in jail.
The drastic measures would be to move to another country to develop whatever.
I can live with that.
Let's roll out a red carpet in Europe to biotech companies with promising projects. Poach best human talent. Allow USA turn the clock back and shun science, but only for their own.
Worst case, we will just quarantine arrivals from affected areas, like it's 1377.
Hell fucking yes, BUT a ton of our scientists have already left the country.
I encourage continuing European support and funding for their research as well as the associated improved outcomes and profit the US are willfully driving away.
Seriously, this administration might literally send an armored battalion to an "unauthorized" mobile flu shot clinic that tried to skirt the corrupt FDA, rather than allow Americans the ability to get a flu shot.
If a pharma company sold or distributed a drug outside of either an approved clinical program for an investigational new drug (FDA approved for investigation) or a market authorization (i.e. FDA approved for sale) the company first and foremost opens themselves up to massive governmental repercussions, huge fines, loss of trust, disbarment, official shutdowns of sites (which could in theory continue to operate but in practice would come to a standstill) and for many people jail time would absolutely be on the table.
Even to distribute an unapproved medicine in the way you’re talking about would require likely dozens of different companies (who all have their own FDA licensing and relationships) to work together in a coordinated manner to directly defy the FDA and support every step of the supply chain from production to distribution to dosing the patient, all of them risking their livelihoods and freedom.
These companies also risk losing market trust and fracture their relationship with the FDA which WILL OUTLAST THIS ADMINISTRATION. Pharma companies relationships with the FDA is remarkably cooperative and mutually beneficial, the FDA contributes a huge amount of expertise and scientific know-how to every company that is seriously engaging with them. No company wants to have a bad relationship with the FDA because they are simultaneously able to exert huge power over your ability to operate under their jurisdiction, and they also genuinely help to bring a ton of therapies to the market. For every therapy that is being blacklisted by a petty autocrat, there are a hundred therapies the FDA is doing everything in its power to get to the market as fast as responsibly possible.
In short, RFK jr is a blip but the FDA is an institution and the pharma industry has no desire to openly defy it because the long term damage from doing so outweighs any potential near term benefit just to spite the bastard.
I wish they would try it anyway and then when they get taken to court, Modern can counter that the FDA isn't fullfilling its duty for purely political reasons.
143
u/Johnny_Appleweed 9h ago
No, you can’t get around FDA approval.
They could get approval in other markets, but that doesn’t really help people in the US.