Rep. Elise Stefanik Attacks Mysterious 'Pedo Grifters' For Shortage Of Infant Formula

SuperMatt

Site Master
Posts
7,862
Reaction score
15,004
Define fault- no they did not create contaminated formula but they allowed this situation to get completely out of hand.

Excuse me, but where did I say the FDA should not regulate baby formula? And I never said anything about “bare shelves Biden” or alluded to such. I said he should have pressured the FDA weeks ago to come up with a solution.

If you care about the safety of babies, then maybe you should consider having the FDA do their job in an efficient and effective manner.

And for the record European formula has been illegal in the US for decades as the US and European nutritional requirements do not align. I don’t know anything about the Trump-Formula situation, but I suspect it probably has a lot to do with the 3 major formula manufactures and farmers lobbying against it. Where the formula comes from is irrelevant and FDA fulfilling their responsibility is not a political issue.

First, why did the FDA go a full 2 years without inspecting Abbott’s facility? Especially one known to have issues.

Why is it that the FDA received a 34 page whistle blower report in October 2021 alleging:
- Falsification of records
- Distributing untested formula
- Staff celebrated the FDA not finding known problems in their 2019 audit
- Improper aseptic technique
- Failing to take action to reduce defects consistent with Good Manufacturing Practices policy
- Failing to properly trace products

The facility did not have an on-site until February 2022, nearly 4.5 months later.

Also in September 2021 the FDA was made aware of an infant death possibly linked to the formula and again, did nothing for months.

And even when the bacteria was confirmed to be in the factory, it took them weeks to inform the public.

And then when the the FDA told Abbott to recall their formula and shut down the factory, they evidently had zero plan of where 30% or whatever of the country would get its formula. And this is on top of a pre-existing supply chain problem.

Now two months later the situation becomes desperate and so then the FDA realizes it needs to find a solution to this that’s faster than the months required to restart the Sturgis factory.

According to Scott Gottlieb, the former FDA head, this factory was known to have “persistent problems” that were “poorly handled” and that the FDA didn’t exert all the oversight that they could have”.

Just about every media source in the country is flabbergasted by the FDA’s repeated failures.

And if the FDA did such a good job, why have they started an investigation into themselves? Why is Congress hounding them for explanations?

This is not a controversial opinion on the slightest.

This crisis obviously stems from negligence from Abbott. But this wouldn’t have happened in the FDA provided the correct level of oversight to begin with (ie not going 2 years without an inspection). Based on other reporting, the inspections that did occur in the past were not particularly thorough. Maybe that promotes a culture of “we can get away not doing x y z”. Maybe better oversight would have caught this problem earlier and maybe the situation would be easier to mitigate.

We’re well past that point though. When the FDA was made aware of problems, they sat on their hands for months. And when the decision was made to close the factory, they evidently made zero plan deal with the consequences- in fact failed to even foresee the potential conflict (watch the CNN interview with the current FDA chief).

This performance should be absolutely unacceptable to Americans. I’m not sure why you’re trying to defend the blatant failures of this agency. If you ignore such circumstances, they are bound to repeat themselves. As I alluded to in my previous post, these shortcomings are nothing new but they never get mainstream media attention because the consequences aren’t felt by a large swath of the country. So many the silver lining is there will be improvements.
I apologize if some of my post was talking past you and past the issue and ranting a bit.

My main point is that the FDA didn’t cause the crisis. Perhaps they are not handling it as well as they could. However, the confluence of multiple factors caused this, and unless some of them are addressed, it won’t matter how much the FDA tries. Here are the issues as I see them.

1. Consolidation: If we had more than 4 companies making formula, then it wouldn’t cause a crisis if the FDA had to shut one down for safety reasons.

2. Tariffs: Why is there a 17.5% tariff on foreign formula?

3: The new NAFTA: It specifically forbids our closest neighbors from selling us baby formula.

4. Regulations on European formula: I hesitate to split this one out because it’s inextricably linked to the tariffs. In order to meet FDA rules, the European makers would have to create special labeling. Add in the 17.5% tariff, and now you have multiple deterrents to them trying to sell formula here.

5. FDA not regulating things tightly enough, allowing Abbott to get to this point.

What if the FDA immediately addressed the whisteblower complaint in October and shut down the factory even sooner? We’d have had the same crisis, just a few months earlier.

Even Scott Gottlieb whom you quoted acknowledged that having only 4 suppliers is a much bigger issue than the FDA’s shortcomings.

So yes, the FDA should improve. They should figure out what they did wrong and do better next time. But if we put all the blame on them instead of addressing the elephant in the room, this will happen again no matter how much the FDA improves.

Thanks for taking the time to respond. I think I found the NY Post article you were referencing with the Gottlieb quote and read through it.

One thing about Gottlieb that I find interesting: when he took over the FDA, he talked about reducing regulations. Well, lax regulations seem to have been a contributing factor here... so maybe he isn’t the best person to throw darts at the FDA for not being strict enough.
 

Chew Toy McCoy

Pleb
Site Donor
Posts
7,515
Reaction score
11,720
You have to jump on those name/year campaign domains quickly ... or this happens :ROFLMAO:


"If you're a Democrat reading this. You better start swinging for the fences. Your bullshit subpoenas and harshly written letters are hilarious. Start punching. Start kicking. Start fighting back. Otherwise, this will continue to slowly become the easiest win for GOP Sycophants."

Amen to that.
 

AG_PhamD

Elite Member
Posts
1,028
Reaction score
969
I apologize if some of my post was talking past you and past the issue and ranting a bit.

My main point is that the FDA didn’t cause the crisis. Perhaps they are not handling it as well as they could. However, the confluence of multiple factors caused this, and unless some of them are addressed, it won’t matter how much the FDA tries. Here are the issues as I see them.

1. Consolidation: If we had more than 4 companies making formula, then it wouldn’t cause a crisis if the FDA had to shut one down for safety reasons.

2. Tariffs: Why is there a 17.5% tariff on foreign formula?

3: The new NAFTA: It specifically forbids our closest neighbors from selling us baby formula.

4. Regulations on European formula: I hesitate to split this one out because it’s inextricably linked to the tariffs. In order to meet FDA rules, the European makers would have to create special labeling. Add in the 17.5% tariff, and now you have multiple deterrents to them trying to sell formula here.

5. FDA not regulating things tightly enough, allowing Abbott to get to this point.

What if the FDA immediately addressed the whisteblower complaint in October and shut down the factory even sooner? We’d have had the same crisis, just a few months earlier.

Even Scott Gottlieb whom you quoted acknowledged that having only 4 suppliers is a much bigger issue than the FDA’s shortcomings.

So yes, the FDA should improve. They should figure out what they did wrong and do better next time. But if we put all the blame on them instead of addressing the elephant in the room, this will happen again no matter how much the FDA improves.

Thanks for taking the time to respond. I think I found the NY Post article you were referencing with the Gottlieb quote and read through it.

One thing about Gottlieb that I find interesting: when he took over the FDA, he talked about reducing regulations. Well, lax regulations seem to have been a contributing factor here... so maybe he isn’t the best person to throw darts at the FDA for not being strict enough.

Again, I never said the FDA “caused” the crisis, clearly Abbott bears the responsibility for operating in such a negligent and corrupt manner. But the FDA certainly has a significant role in not properly fulfilling their responsibilities to monitor the safety of the facility and address problems in a timely manner. And when they knew the plant was going being shut down, they should have been planning for a contingency- especially in light of existing supply chain difficulties- rather than waiting 2 months. That includes finding other means of domestic production, importing foreign products on an emergency basis, finding a way to continue plant operations while also rectifying the underlying problems. I think we’re in agreement here, it’s just a matter of semantics.

I would also entirely agree the politics (tariffs, regulations, etc) of the US formula industry resulting in only 3 providers is an inherent problem, though it had Abbott and the FDA been more responsible wouldn’t be here. As I mentioned before, I suspect these policies have to do with protecting the domestic monopoly, farmers, etc aka political nonsense. Just like how the US has the 25% “chicken tax” on foreign made light trucks to protect our big 3 auto makers or how China has a 25% and India 100% tariff on all foreign passenger cars in order to boost their own domestic auto industry. Obviously baby formula is a bit more important than cars. In reality the 17% tariff on formula probably has little effect on imports considering most formula doesn’t meet regulations to begin with and therefore is illegal.

The pandemic is a prime example of depending on one source (China) for a substantial amount of drugs, drug precursors and excipients, and medical supplies. Prior to the pandemic there were actually a lot of concerns that Trump’s trade war could result in China cutting off pharmaceutical supplies. Events like these are clear indicators virtual supplies need diversified sourcing. If we’re going to rely on a small number of suppliers (or country), then there needs to be a viable contingency plan.

I’m not sure what regulations he wanted to reduce, that’s a very vague statement as the FDA regulates a lot of products and has endless regulations. He did want to increase regulations on tobacco products (ie limiting nicotine, banning menthol; etc). Without knowing what specific regulations I can’t comment, but even if his ideas were not sensible, it doesn’t mean he’s wrong in this case or that he want to cut regulations on baby formula. I would expect he’d have a good idea of Abbotts reputation with the FDA and regulatory authority they can wield.

FDA leadership typically does not outright condemn FDA leadership predecessors/successors as the whole system is supposed to be built on trust and safety- much like you don’t see Boeing and Airbus calling each others products unsafe as promoting aviation as a safe industry has mutual benefits. When he says they “could have done more” that’s the subtle way of saying they f***ed up.

I’m glad to see the FDA is (finally) taking concrete steps to help mitigate problems in the short term, including importing foreign products. This is a relatively easy solution considering baby formula doesn’t require FDA approval like a medication, it just has to meet FDA nutritional standards which they of course can dictate.

I will say the people (often Biden opponents) screaming for Biden to enact the defense production act don’t understand that the DPA doesn’t magically make products appear out of thin air overnight. Obviously other companies will ramp up production as much as they can, as fast as they can to take advantage of the market. If the DPA was used, by the time these companies production infrastructure was expanded it would be long after Abbott gets back online.
 

JayMysteri0

What the F?!!!
Posts
6,612
Reaction score
13,752
Location
Not HERE.
You have to jump on those name/year campaign domains quickly ... or this happens :ROFLMAO:

https://www.twitter.com/i/web/status/1526549353053229064/
evil-laugh-rub-hands.gif
 

GermanSuplex

Elite Member
Top Poster Of Month
Posts
2,515
Reaction score
6,142
Its empty rhetoric. It’s more cult/conspiracy garbage at best, or usual GOP projection at worst. I guess when you caucus with Gym Jordache and Matt Gaetz, you’ve got to get out ahead of the accusations, so just accuse the other side.

Seriously though, it’s the usual baseless stuff that for whatever reason has stuck with the GOP echo chamber. The Clintons are murderers, the left is full of pedophiles, anyone who disagrees with Trump is a RINO, only the left commits mass murder or are racist, etc.
 
Top Bottom
1 2