"The problem with insulin costs is that the government will shoot anyone who tries to make cheap insulin." https://t.co/hmVWCTuT3V
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Replying to @s_r_constantin
> the median approval time did not significantly decline > increase in approved drugs was largely driven by approvals of the fourth, fifth, sixth versions of genericshttps://www.pewtrusts.org/en/research-and-analysis/issue-briefs/2019/02/fda-approves-more-generic-drugs-but-competition-still-lags …
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Replying to @peroxycarbonate @s_r_constantin
> Before GDUFA (see fiscal 2012), the median approval time was 31.75 months, but median approval time was 36 months in fiscal 2013. Median approval time increased to 42 months in fiscal 2014 and 2015 before declining to 39.42 months in 2016 and 37.26 months in 2017.
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Replying to @peroxycarbonate @s_r_constantin
Now, I'm not sure exactly what you're proposing Sarah. Do you think drug manufacturer's shouldn't need FDA inspections? That's a hard sell. Do you think the FDA needs more money for inspectors? Congress could do that, if it thought that would win elections.
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Replying to @peroxycarbonate @s_r_constantin
Maybe no fees for drugs not currently being made? But then you have a new review process taking 3 years, before the drugs get made. Maybe the problem is the review process taking 3 years. But how, exactly, are you going to fix that?
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Replying to @peroxycarbonate
Oh, I'm too radical to have any intuition at all what kinds of incremental policy are within the Overton Window. (
@bkavoussi?)2 replies 0 retweets 2 likes -
My guess would be the incremental approach would be "purity testing only, no human trials, and fees scale with the size of the manufacturing operation." But, again, I don't know what Congress would go for, which is why my speculative proposals are about direct action not law.
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Replying to @s_r_constantin @bkavoussi
Generic versions of existing drugs don't require clinical trials for approval. That's what we're talking about here, right?
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Replying to @peroxycarbonate @bkavoussi
No, they don't need the full clinical trial process, but they do often have to be tested on patients to show that they have the same bioavailability as the brand-name drug.
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Replying to @s_r_constantin @bkavoussi
I don't think bioequivalence certification requires human trials. IIRC bioequivalence studies involve spectroscopy, testing particle sizes, and tests on animals.
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Replying to @s_r_constantin
That's for "biosimilars" not bioequivalence. That link says: > By contrast, the typical generic drug takes firms 1-3 years, $1-$5 million, and no human clinical trials to introduce.
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