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Cost of developing new drugs may be lower than industry claims: trial

(www.theguardian.com)
275 points swores | 3 comments | 25 Apr 24 12:25 UTC | HN request time: 0s | source
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pfisherman ◴[26 Apr 24 19:32 UTC] No.40173162[source]▶
Without comment on the broader subject of drug pricing - especially in the US - this article leaves out enough relevant information that I would consider it to be intellectually dishonest.

Where did they run the trials? Across how many sites? Do they plan to apply for marketing approval in the US or EU? Are they the manufacturer? Did they beat the cost of setting up the supply chain and manufacturing facilities prior to the phase 2/3 trials?

The answers to those first three questions will have a huge impact on the price tag.

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1. PinkSheep ◴[26 Apr 24 20:36 UTC] No.40173973[source]▶
> US or EU?

I'm a bystander, but the gist I got from the official lists and trials is that each EU country needs it's own approval with the gov agency. It may be that "being EU" has equalized requirements to an extent, but each wants their own. (bureaucracy kills?)

One example I read about was a yet experimental drug made by a Swiss company, but the trials only run in and for the US for financial and market reasons.

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2. pfisherman ◴[26 Apr 24 21:17 UTC] No.40174413[source]▶
USD has the FDA and EU has the EMA. I am not sure how EMA interacts with each individual country.

While regulatory agencies may consider data generated from trials in other jurisdictions, they may ask questions about whether those data and conclusions and relevant and generalizable to their patient populations and health care systems.

There are also ethics to consider. Sure it may be cheaper to run trials in developing countries. But at what point does it become exploitative? Keep in mind that we are talking about human experiments, which is very serious business.

3. frodo8sam ◴[26 Apr 24 21:30 UTC] No.40174533[source]▶
No the EU has the EMA which approves drugs for all European countries in collaboration with national drug agencies. And the EMA FDA and japanese agency are pretty well aligned. So approval by one will typically mean you also meet the requirements for the others. Notable exceptions are the recent Alzheimer drugs.