“I don’t see that the FDA can argue safety if the same drug, manufactured in other countries, has been used by them for years without any trouble.”
We all know what happens if the fox is allowed to guard the henhouse… Are you going to trust Indian, Chinese, Russian, etc. authorities with their assessment of safety? I would not. One example: kiddo is working on a project that involves massive crunch of data on infectious disease rates, and some data coming from those countries reek of fudging. A few lives here and there lost to the side effects from a contaminated pill? To the officials in those countries, nothing. I would want a complete review and inspection by the FDA of the facilities and the manufacturing practices prior to importation of generics and non-patented drugs.
I re-read the Fierce Biotech article I linked earlier. He is scummier than we thought. To keep the activists at bay, he would reimburse the patients whose insurance would not cover the drug. The others would not even be aware of the price hike because their insurance absorbed the cost… and later passed it on to all insured via rate increases. Either way, the patients end up paying for his activities. Drug development, my rear end! There are legitimate, ethical ways to fund a company: VC, angels, SBIR, DARPA, etc. grants.
If Mr. Scumbag holds the patent, is that worldwide? Could that same drug be manufactured elsewhere, and then sold in the US? Or does his patent preclude sale in the US, no matter where it’s made?
"The drug made by generic companies abroad costs only about $20 for 100 capsules.
Amir Attaran, an expert on pharmaceutical access issues at the University of Ottawa, said it would have made much more sense to just import the drug from abroad, rather than have it produced in America for so few patients at such high cost.
Mr. Hasler said this was probably not done because foreign manufacturers were not willing to bear the expense of applying for regulatory approval in the United States."
This is a quote from the NYTimes article.
There would be no profit given the high cost of regulation versus the low number of patients.
Scumbag doesn’t hold the patent. The drug is generic. But for a competing generic drug to be approved for sale in the US, it has to be tested against the existing version (Scumbag’s version) and he is making it impossible for competitors to get enough of the drug to do the test.
Importing is not impossible, just impractical and not profitable, given the regulatory costs. In such a situation, one would think the FDA would work to relax the regulations. They seem to be an obstacle just as the new owner is. Even the threat of approving imports from another country of this same drug would pressure the new owner to lower the prices.
Importing is only possible if we decide that imported drugs don’t need to be tested against current drugs, which Mr. Scumbag has made impossible in this case. (You surely don’t think that this is the last time this will happen.) So the answer is to NOT to rein in predators, but rather to let them ravage the healthcare landscape, and then work around them as best we can. You don’t see any problem with that? Why is it that predators’ rights to predate are the one thing that can’t be questioned?
Would it be illegal for a group, such as an HIV support group, to pay to send an individual to India and purchase several year’s supply for all 1200 patients, and then distribute them, possibly for free? Would it be illegal to set up a non-profit to do this?
Drugs imported from overseas have to be approved by the FDA. Who wrote the laws requiring the approval process? Often people will blame regulations, when the issue is really caused by legislation–and the lobbying that shaped the legislation.
In this case, I don’t know the details, but is it in the interests of big pharma in the US for it to be easy to import drugs?
Well, there you go. Up here near the Canadian border, people were organizing bus trips to buy medications more cheaply in Canada. There was some question about its legality.
The way I look at it, this is the same thing as medical tourism, where people go to countries such as Thailand to have procedures done at a fraction of the cost in the US.
Demand? It’s Turing’s private property. There would be blood-curdling howls of outrage at the overreach of big government. But if we want to go with eminent domain for pharmaceuticals, it’s my understanding that Turing would have to be compensated for that. You want your tax dollars to go to private profiteers to stop them from threatening pharmaceutical supply lies? But that would be a neat little scheme for future vulture capitalists, and they don’t even need to go to the bother of manufacturing and distributing the finished product. Simply buy up all the supply of a cheap drug, and then demand ransom from the American taxpayers to avoid massive price increases.
You’re sure it wouldn’t be easier just to outlaw predatory pricing? Insurance companies are no longer allowed to gouge, and they’re doing just fine.
Well the government manufactured demand by implementing a tax for not having health insurance and also subsidizing the cost for low income consumers. And prices have risen for the young because they’ve had to balance out how much everyone pays. So not a great example.
We should be allowed to import. If the regulations have created this situation, clearly the regulations are wrong, and should be corrected so they aren’t wrong anymore.
As for what can be done immediately? Nothing I know of. The patients are being gouged and nothing illegal has happened. But hopefully if the regulations around importing are corrected then this won’t happen again.
So what should we do to correct the problem - loosen up the regulations on imports or get new regulations prohibiting price gouging in situations like this one? Hint: the PB guy was getting away with selling tainted PB because the regulators had limited resources…
So Vladenschlutte, it’s just too bad for those patients, eh? It’s more important to preserve the rights of gougers than to make medicine affordable for sick people? Interesting priorities.