[kragen]

What reduces the risk that a drug will be dangerous is testing, quality control, replication, and transparency. Regulatory compliance is, at best, a means to those ends, not an end in itself. At worst, and far too often, it's a major obstacle to them.

People don't have to be evilly plotting when their incentives are set up to empower only people who do evil things. Don't forget that, in the US, we're talking about the same regulatory regime that rejected magainin, hasn't brought a new class of antibiotics to market in half a century, has outlawed the flavored vape liquids that help people quit smoking, won't allow you to buy a blood sugar meter until after you have diabetes, prohibited covid testing at the beginning of the pandemic, delayed covid vaccination until five or six months after China was doing mass vaccination, and routinely cuts off opiate addicts cold turkey. It's a Kafkaesque farce, as you know very well, and quite possibly the primary cause of death in the US today.

[dekhn]

So, uh, how are we going to ensure that all that testing, QC, and transparency occurs... without some sort of regulatory agency that enforces it? and that agency woudl use compliance (submit this and that form and follow this and that process)... so it would seem that they act as proxies for the value of the things you listed.

[kragen]

In the comment you responded to, I am not taking up the subject of how to achieve testing, replication, QC, and transparency. I am merely pointing out that, to reason clearly about the issue, it is essential to distinguish these goods—genuinely valuable benefits to drug users which should be maximized—from any potential means for achieving them, such as regulatory compliance, which is a deadweight loss to be minimized, even if it is an unavoidable one, as you claim it is.

To do otherwise is similar to measuring the progress of a software project in lines of code, measuring the quality of an airframe design by its weight, or measuring the security provided by the TSA in the number of fingernail trimmers confiscated. It's counting regulatory compliance activities on the wrong side of the ledger.

[erosenbe0]

The people who write the rules take money from the rent extractors and the people who enforce the rules have huge conflicts of interest and go immediately to and from working with the rent extractors. It is a corrupt system of rent extraction that has some quality benefit for the consumer that is extremely inefficient. CRONY-CAPITALISM, MONOPOLIES past patent expiration, and A LACK OF A FREE-MARKET extracts rent from the consumer and destroys a countries' industrial competitiveness as does any form of corruption. Just look up how many generics are available in somewhere like India, or look at drug costs on the Mexican [more] free-market, or just do some research into what is actually happening.