That’s the estimated cost of developing a new drug and bringing it to market.
And GSK had ~$16 billion in _profit_ last year. It has been profitable for the past 15 years, usually in the $4b range.
They are choosing to not bring this product to market. They are also choosing to not allow another company bring it to market.
That is clearly the best business choice for them according to their accounting, but they aren’t limited in trying to do it.
"Safety costs too much. The fda should make the decisions based on what would be best for the billion dollar corporations!"
Or maybe they should have the US distribution rights seized and testing paid for and then the product profited on by tax payers instead of a private corporation? Win win for everyone but the billion $ corporation.
don't really see "fuck it, make us less safe so corporations can make more money" as rational policy.
And if you don't think drastically reducing the barriers to entry for products in to the us would make us less safe I'm certainly open to hearing how.
The current model works very well for the billion dollar corporations, largely because they're the only ones who can afford to follow the FDA requirements.
> And if you don't think drastically reducing the barriers to entry for products in to the us would make us less safe I'm certainly open to hearing how.
Most of the barriers to entry are more bureaucracy than safety, and the net effect is fewer medicines are available and those that are are more expensive. The greatest success story of the FDA is thalidomide, which killed or seriously injured around 100,000 worldwide over 50 years ago; meanwhile about 45,000 americans die every year from not being able to afford medical treatment, and that only accounts for medicines that made it through the approval process, not those where it wasn't economical to try.
Regulations suffocating progress is a real problem. It's why, aside from ASML and Spotify, the EU's tech industry has stagnated for 20 years.
The FDA should subsidize safety studies for drugs like this. This would actually make it more likely to get useful, functional drugs in the hands of Americans more quickly, ie the whole point of this article.
Its not the safety studies. I'm sure the safety studies were done in other countries so they can submit it in the US. But if the company claims some beneficial properties to your body then its considered a drug and they need to show efficacy. But if they didn't advertise Novamin as an active ingredient they could sell it in the US but then they can't claim the benefits of that ingredient. I'm not sure how in the EU they can claim benefits without trials.
costs billions of dollars. that's the FDA's fault.