re: The FDA drives up the cost of health care and kills people

In the example in the OP clearly the FDA's construction of entry barriers is on display to the determent of the citizens.

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Again you are referring to law which is enforced buy the FDA

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I support Congress ending the FDA---how's that?

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Also, the orphan (and especially the ultra-orpan) status allow drug companies to bring a drug to market for a very limited population while saving the money it would take to get through th clinical phases necessary for normal approval. I mean for the most part we are talking about conditions that affect as little as 10s of thousands people world-wide. Without this the DCs have little chance of these drugs coming to market.

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The only reason the orphan drug program exists is because of the stupid regulations that require drugs that have proven safe for decades in Europe to undergo entirely new rounds of testing in the US, which are too expensive to justify when the patents are usually expired.

The FDA should just adopt reciprocity with the EU, Japan, and other countries whose drug regulations are already stricter than ours. No "orphan" designation, not exclusive rights accruing just because someone paid for some tests that are a foregone conclusion.

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What in the frick does the FDA have to do with this? All they did was approve the drug. It wasn't their decision to raise the price 5,000% or more.

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The mere existence of the FDA is the reason this drug hasn't been on the market here years ago.

It is their existence that prevents competitors from formulating a copy of this drug. It is their existence that keeps the drug from being imported now.

How "the frick" can you not see how the FDA protects the profits of drug companies?

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Are you fricking kidding me? The tort system? The one that in lots of places puts caps on damages at levels that any Big Pharma company would laugh at?

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What are you telling me now? that our tort system is not a deterrent and we should do away with it? There are no caps on federal tort and today it is more of a deterrent to bad drug companies than is the FDA.

You people are crazy. We pay more for drugs than ANY OTHER COUNTRY in the world and you want to protect the system. You want a huge bureaucracy.

End most prescription requirements for common drugs like antibiotics and statins with long histories and end the FDA as we know it today. Even broader--end the laws that require government approval of drugs altogether. If you want an agency that simply verifies claims made by drug marketers I would support that but I do not support the government having the authority to restrict the sell of pharmaceutical drugs.

I have already said I think we should end the patents granted for new uses of established compounds. Patents for new compounds should remain as they are.

What is crazy is to support putting the government between sick people and the cures they seek.

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The only reason the orphan drug program exists is because of the stupid regulations that require drugs that have proven safe for decades in Europe to undergo entirely new rounds of testing in the US, which are too expensive to justify when the patents are usually expired.

The FDA should just adopt reciprocity with the EU, Japan, and other countries whose drug regulations are already stricter than ours. No "orphan" designation, not exclusive rights accruing just because someone paid for some tests that are a foregone conclusion.

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this I'm sick of the government telling me to pay out the arse so that it can "make sure I'm safe". They just want to make sure everyone gets their cut. Why do I need to see a doctor who spent 15 years in college, med school, residency just so I can get a refill on my blood pressure medication or tell me I have the flu.

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The company in your OP is ripping off sick patients. How are consumers doing when they have to regulate on their own?

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How are consumers regulating themselves when they are forbidden from importing a drug that has been deemed "safe" by the FDA? Consumers can't regulate when, by government regulation, they only have one option.

Pharmaceuticals are different because goods are inelastic and consumers cannot "switch" as easily to another equal alternative.

Very easy for consumers to aself regulate beverage companies. Not so much with pharmaceuticals required to live.

Without patent protection, we undoubtedly have a lot less money spent on R&D. These are trade offs and I am not saying our system today is anything close to perfect. Nonetheless, patent protection plays an important role in driving forward our search for cures.