Thread: Ebola

Building a plant to run manufacture of medicine based on biological processes (i.e. the product is the output of biological processes in a bioreactor) costs in the order of hundreds of millions. Keeping that same plant running in compliance with the various international regulations (FDA, EMEA, etc) costs in the tens of millions easily. And bringing a product into manufacturing AND getting it approved by the various agencies is a process of many years and many tens of millions.

So ramping up for ebola is not a trivial thing by far.

Btw, healthcare cost is not just a matter of the US paying for research. Lots of ground breaking medical research is done in Belgium without causing me to pay through the nose for something simple. The biggest contributing factor to that is the fact that in the US, healthcare is seen as something that should generate big bucks instead of being basic infrastructure that should be available to all.

That, and the monopoly issue is what can cause your pill to be 20$ in the US and 1$ in India.

Originally Posted by Bruno

Building a plant to run manufacture of medicine based on biological processes (i.e. the product is the output of biological processes in a bioreactor) costs in the order of hundreds of millions. Keeping that same plant running in compliance with the various international regulations (FDA, EMEA, etc) costs in the tens of millions easily. And bringing a product into manufacturing AND getting it approved by the various agencies is a process of many years and many tens of millions.

So ramping up for ebola is not a trivial thing by far.

Btw, healthcare cost is not just a matter of the US paying for research. Lots of ground breaking medical research is done in Belgium without causing me to pay through the nose for something simple. The biggest contributing factor to that is the fact that in the US, healthcare is seen as something that should generate big bucks instead of being basic infrastructure that should be available to all.

That, and the monopoly issue is what can cause your pill to be 20$ in the US and 1$ in India.

Another issue that we run into here in the US is that the FDA doesn't often recognize approvals done by other "FDA-type" agencies in other countries. The European Medicines Agency and Health Canada are often easier to get approval from, and approval in either will = approval in both, but the FDA doesn't honor that type of agreement. So drugs that are available in Europe might not be available here. The FDA is often much more difficult to get approval from than any other agency. For instance, I'm working a device through the FDA now for treating balance disorders in patients with traumatic brain injury, MS, Parkinsons, etc., and we'll likely have approval through Health Canada within a year whereas it's going to take 2-3 years here in the US.
Even worse, I've seen more than a few good start-up companies go out of business because it takes so long to get approvals done. New companies have limited resources and sometimes simply can't stay afloat while waiting 3, 4, 5 years to get their product to market.

Just read this:
Leaked documents reveal behind-the-scenes Ebola vaccine issues | Science/AAAS | News

This is a surprisingly good summary of the issues in ramping up vaccine delivery scheduled while at the same time complying with the regulations involved in clinical trials and getting formal approval. It's not simple at all.