Or just abolish the FDA?
They're the ones keeping competitively priced insulin out of the market.
https://mises.org/wire/patents-legal-monopolies-and-high-pri...
https://mises.org/wire/patents-legal-monopolies-and-high-pri...
The FDA, from my perspective, plays such a huge and important role in our society and showcases the exact things we need from our government. They are an example of a government entity that mostly gets the job done right, an essential part of our livelihood today.
In 1960, Richardson-Merrell applied for approval for a drug called Thalidomide, a cancer treatment. They had clinical trials that included pregnant women. They were rejected six times.
In the UK, The Distillers Company (Biochemicals) Ltd, a subsidiary of Distillers Co. Ltd marketed thalidomide as Distaval, a remedy for morning sickness. Their advertisement claimed that "Distaval can be given with complete safety to pregnant women and nursing mothers without adverse effect on mother or child ... Outstandingly safe Distaval has been prescribed for nearly three years in this country."
By 1962, over 10,000 children (most in west germany) were born with crippling disabilities caused by thalidomide. Over 2,000 died.
Frances Oldham Kelsey was awarded the medal for Distinguished Federal Civilian Service by President John F. Kennedy for rejecting the drug.
That is to say, the inefficiency of the FDA was, in the words of the FDA itself, directly responsible for the premature deaths of 100,000 Americans. And that was for beta-blockers alone.
I laughed when watching an FDA press conference during covid, where the spokesman said that the agency was streamlining approval measures to get covid vaccines approved faster. A journalist asked if this would negatively impact the safety or efficacy of the vaccine to which the FDA head confidently replied that it would have zero material impact. It makes you wonder, if they are capable of quickly making approval decisions without sacrificing safety or efficacy standards, why is that not standard operating procedure? There are no answers that don't lead one to conclude that the FDA is a bloated, bureaucratic, wasteful mess.
That's easy. The normal process has multiple trials:
Phase 1: 50 people Phase 1: 200 people Phase 3: 100,000 people
Normally, you pass each phase before exposing a larger number of people to risk. More people means you can find rarer and smaller effects, but if you haven't tested on <50 people first then you might really endanger the group of 200 or 100k.
The expedited process tests it on 100,250 people at once. THOSE people are exposed to more risk, but the safety of the vaccine is the same. And because the vaccine was proven safe, those people were not negatively impacted any more than if they had followed the normal process.
> There are no answers that don't lead one to conclude that the FDA is a bloated, bureaucratic, wasteful mess.
No, you're just not actually looking.
It also tries to blur between patents and exclusivity. Exclusivity is usually 3 years (5 for new antibiotics and new chemical entities). Patents are 20. Exclusivity is a very small portion of intellectual property protection. I would call that dishonest.
The FDA does not control drug patents, the patent office does. Abolishing the FDA would do practically nothing to reduce IP protections, but would eliminate all the other things they do, like making sure drugs work and don't kill people.
Like they did with Thalidomide?
Abolish both the FDA, and IP.