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.
