The existence of problems does not imply there cannot be more plentiful, more diverse, and more severe problems in the near future.
Or, conversely, important things may have been relying on access via the latch-free fence gate: fixing the latch without providing a more appropriate solution to those issues could cause more harm than the benefit you get from "now the fence actually functions as a barrier". (Sure, the latch keeps the wolves out, and stops them picking off the sheep – but it also keeps the sheep away from their only freshwater source, without which most of the sheep are going to die.)
So uhhh, maybe we think in reality instead of offloading to metaphor.
we also know for a fact that the FDA lets unsafe and ineffective drugs into the market, especially from overseas, slapped with a label that its safe according to the FDA. if its a crapshoot, what's the point really?
99.99999% of drugs ever created are unsafe or ineffective.
99%+ of the drugs you will ever encounter in your life are both safe and effective.
That is not a crapshoot. Obviously.
https://www.propublica.org/article/fda-drug-loophole-sun-pha...
Despite its failures (however many you want to point out), our regulatory regime converts a pipeline of almost universally ineffective and/or dangerous compounds into a marketplace of almost universally safe and/or effective compounds. This is a fact.
Unless you think no one is trying to, would try to, or would deceive themselves into accidentally releasing a dangerous or ineffective compound to consumers?
The real challenge lies in the expectations the FDA has set for manufacturing. Over time, the regulatory space has been heavily influenced by academic-driven theoretical scenarios for microbiological contamination. While well-intentioned, these theoretical risks often drive overly stringent requirements that don’t always reflect real-world manufacturing risks.
As a result, it’s becoming prohibitively expensive to manufacture drugs for the U.S., especially sterile injectables.
And truly it gets worse every year…
> Digging through company records and test results, they found more evidence of quality problems, including how managers hadn’t properly investigated a series of complaints about foreign material, specks, spots and stains in tablets.
> Those unknowns have done little to slow the exemptions. In 2022, FDA inspectors described a “cascade of failure” at one of the Intas plants, finding workers had destroyed testing records, in one case pouring acid on some that had been stuffed in a trash bag. At the second Intas factory, inspectors said in their report that records were “routinely manipulated” to cover up the presence of particulate matter — which could include glass, fiber or other contaminants — in the company’s drugs.
> Sun Pharma’s transgressions were so egregious that the Food and Drug Administration imposed one of the government’s harshest penalties: banning the factory from exporting drugs to the United States.
> A secretive group inside the FDA gave the global manufacturer a special pass to continue shipping more than a dozen drugs to the United States even though they were made at the same substandard factory that the agency had officially sanctioned. [...] And the agency kept the exemptions largely hidden from the public and from Congress. Even others inside the FDA were unaware of the details.
FDA inspectors found actual, live contamination in drugs produced by a manufacturer, and the agency secretly (otherwise, it would have caused "some kind of frenzy" in the public") gave it an exemption anyway, to make sure supply wasn't impacted. This isn't a "funding" issue, and it's not a "regulations are too strict" issue. This is an issue with the people running the agency behaving completely inappropriately.
If the government had said the imports from India are not allowed due to insufficient quality controls, then the market price for the generics would increase in the US, maintaining the necessary profit margins for the manufacturers to provide higher quality medicine produced at higher cost.
https://www.npr.org/sections/health-shots/2019/05/12/7222165...
>Internal divisions and pressure from Congress also limited the FDA's response to overseas violations,
whistles
>delays in launching a generic version of Lipitor could cost Americans up to $18 million a day, according to a 2011 letter from a group of U.S. senators to the FDA commissioner.
The FDA chose a practical middle ground. Ban what isn't critical, and for those that are, they put additional mitigations in place:
> Exempted drugs were sent to the United States in a “phased manner,” the company said, with third-party oversight and safety testing.
>“The odds of these drugs actually not being safe or effective is tiny because of the safeguards,” said one former FDA official involved in the exemptions who declined to be named because he still works in the industry and fears professional retribution. “Even though the facility sucks, it’s getting tested more often and it’s having independent eyes on it.”
the article states "And the agency kept the exemptions largely hidden from the public and from Congress."
How so, are the examples?
The FDA maintains a public red list of companies with import bans, and a green list companies operating under exemptions.
What transparency are we talking about?
*He and his colleagues had also been engaged in a decades-long debate with a sprawling community of watchdogs — mostly doctors, lawyers and scientists from outside the agency — who were often broadly supportive of the agency’s mission but who fought with officials like Califf, sometimes bitterly, over the specifics: How should the F.D.A. be financed? What kind of evidence should new drugs and medical devices require? How should regulators weigh the concerns of industry against the needs of doctors, patients and consumers?*> politically unpopular drug shortages ...
Ask your ADHD friends about how they get their meds.
One side wants to keep it, the other side wants to get rid of it. No one wants to fix the problem.
That’s not what wedge issues are for. They’re not meant to be solved, because then they’re used up, and there’s airtime to fill in the meantime.