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Me for FDA chairperson
Jun. 29th, 2011 08:27 amWhen my doctor prescribed me hydrocortisone, it was in 20mg tablets. Not a big deal when I was taking 50mg, but now I'm at ~5, or I would be if pill splitters could reliably do quarters, which they can't. A skilled operator can get halves pretty reliably, but not quarters, and even the best will lose some to powdering. My doctor gave me the 20mg pills anyway because there was a shortage of the 10s. "Why is that?" I thought quietly to myself. "Surely if you can make one you can make the other. And it's a generic medication made by many manufacturers. Why aren't they boosting production?" It turns out the answer is they're not allowed to.
WTF mate? Apparently you have to tell the FDA how much drug you're going to produce, and you can't up it without permission even if it's a leukemia drug and the FDA just shut down your competitors' plants so doctors are being forced to give patients sub-optimal treatments for their cancer.
The one thing that bugs me about this article is that it doesn't go into much detail on the review process. If all you have to do to produce more lifesaving medication is e-mail the FDA, I'm still against it, but it wouldn't account for the shortages on its own. Unfortunately I don't have access to the list of limited access drugs, but everything I've seen mentioned is off patent, which gives me the sneaking suspicion that it's not financially lucrative to apply for- either because the profit margin on generics is so low to begin with, or because you're required to give a discount to certain medical providers that target the poor, and can cherry pick who you distribute to first. Which doesn't let the federal government off the hook, because they're the ones making it expensive to produce more for no valid reason, if they want a thing they should raise taxes and pay for it, not mandate that it be sold below cost.
I'm still trying to figure out why they have the limits in the first place. Some of it is the DEA wanting to limit abuse, which starts me on another rant about how we'd rather have people live in excruciating pain (or have their ADD undertreated) than have some other people enjoy something inappropriate, but I doubt a chemotherapy drug can be used recreationally, and presumably 20 mg tablets of hydrocortisone are easier to abuse that 10 mg tablets. I refuse to be one of those libertarians that thinks the government does stuff just to be mean, but it's sure looking plausible here.
Good news though: new job gives me interlibrary loan access to the university library, which has Overdose, a book on prescription regulation I've been coveting for a while but was not quite ready to purchase or pay for city-library interlibrary loan. For a bit I felt guilty about using this for non-work purposes, but then I realized I could just donate to either institution an amount that was more than it cost them to fetch the book for me (almost, but not quite nothing) but less than it would cost me to get it through public library interlibrary loan ($5, plus it takes more time to pick up the book). It's a win for every one.
WTF mate? Apparently you have to tell the FDA how much drug you're going to produce, and you can't up it without permission even if it's a leukemia drug and the FDA just shut down your competitors' plants so doctors are being forced to give patients sub-optimal treatments for their cancer.
The one thing that bugs me about this article is that it doesn't go into much detail on the review process. If all you have to do to produce more lifesaving medication is e-mail the FDA, I'm still against it, but it wouldn't account for the shortages on its own. Unfortunately I don't have access to the list of limited access drugs, but everything I've seen mentioned is off patent, which gives me the sneaking suspicion that it's not financially lucrative to apply for- either because the profit margin on generics is so low to begin with, or because you're required to give a discount to certain medical providers that target the poor, and can cherry pick who you distribute to first. Which doesn't let the federal government off the hook, because they're the ones making it expensive to produce more for no valid reason, if they want a thing they should raise taxes and pay for it, not mandate that it be sold below cost.
I'm still trying to figure out why they have the limits in the first place. Some of it is the DEA wanting to limit abuse, which starts me on another rant about how we'd rather have people live in excruciating pain (or have their ADD undertreated) than have some other people enjoy something inappropriate, but I doubt a chemotherapy drug can be used recreationally, and presumably 20 mg tablets of hydrocortisone are easier to abuse that 10 mg tablets. I refuse to be one of those libertarians that thinks the government does stuff just to be mean, but it's sure looking plausible here.
Good news though: new job gives me interlibrary loan access to the university library, which has Overdose, a book on prescription regulation I've been coveting for a while but was not quite ready to purchase or pay for city-library interlibrary loan. For a bit I felt guilty about using this for non-work purposes, but then I realized I could just donate to either institution an amount that was more than it cost them to fetch the book for me (almost, but not quite nothing) but less than it would cost me to get it through public library interlibrary loan ($5, plus it takes more time to pick up the book). It's a win for every one.
