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b_b  ·  366 days ago  ·  link  ·    ·  parent  ·  post: Critical Condition: Inside Pfizer’s Drug Supply Problem

This was not the article I expected it to be. By the title, I assumed it was an evil pharma story about jacking up prices or artificially creating a shortage to increase profit taking.

I've had some lessons recently on how the FDA does business, and it's left me unimpressed. The staff there have to be experts in everything, which of course they aren't because no one is. And they're in a tough spot because they get all the blame when something goes wrong and none of the credit when things go right. That's what has led to the situation described in the piece, where the FDA just makes boxes to check and if you don't check the boxes you can go fuck yourself.

I know the guy who led the regulatory work on the drug Wellbutrin (on the manufacturer side; not the government). According to him--and he swears he isn't exaggerating--they had 16 semi trucks filled with papers that they needed to provide to the FDA (apparently there were like 200,000 patients in the trial). What possible benefit to humanity is 16 semi trucks filled with paper? The FDA says they read everything (by law they have to), but is that even possible? Does it make the drug safer or more effective?

We definitely could use regulatory reform in the drug approval process. I don't know much of anything about generics, but those should be the easiest to make and have approved (since the only reason they exist is because their safety and efficacy profiles are well described due to their long history). Maybe the solution is something as simple as better leadership at the FDA. I don't know that that's possible, because if there's even a small problem the hand wringing from Congress is likely to be severe (chip shot political points). Perhaps we could have some sort of tax policy that better supports generic manufacturing, as well.