Friday, February 09, 2018 4:57:13 PM
As for the DOD's rights, I know they work in conjunction with the FDA, but they are much freer to meet their needs, with FDA concurrence. The FDA has routinely allowed them to purchase drugs that were never approved for te general public. I'm not an expert on this, but did work with a Navy Commander who was butting his head against the wall in attempting to learn the experimental drugs he'd been given when first recruited, he was trying to determine if they could have caused the health problems he had roughly 20 years later.
Don't get me wrong, the DOD won't purchase against the FDA's advise, but the FDA doesn't require the same burden of proof on a drug the FDA wants to purchase. The DOD could ask the company to, for instance, expand on a Phase 2 Trial to gain sufficient data for them, while the FDA would demand a Phase 3 Trial for general approval. In doing so, the DOD would have the FDA's agreement. I'm not saying this is the case, just that their is far more flexibility when working with the DOD.
As a retired DOD employee, I frequently saw how funding affected work, especially at the end, or beginning of the fiscal year. I can't say how many times we went from forced leave to maximum overtime in a matter of weeks. I've fought to get things like computer's for years, then suddenly was told, get them, but everything must be processed in a matter of days. Sometimes we got lucky, but in most cases it was impossible to get it done in time. Fiscal funding is one of the stupidest thing we do, especially when it comes to long term projects.
Gary
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