Scott Alexander finds, to his surprise, that two of the candidates for the post of FDA commissioner in the Trump administration are following his blog or social media profile. To mark that, he offers five easy-to-implement policy fixes that would make a difference:
1. Medical reciprocity with Europe and other First World countries […] Right now, Europe has a licensing agency about as strict as the FDA approving medications invented in Europe. Any pharma company that wants their medication approved in both the US and Europe has to spend a billion or so dollars getting it approved by the FDA, and then another billion or so dollars getting it approved by the Europeans. A lot of pharma companies don’t want to bother, with the end result that Europe has many good medications that America doesn’t, and vice versa. Just in my own field, amisulpride, one of the antipsychotics with the best safety/efficacy balance, has been used successfully in Europe for twenty years and is totally unavailable here despite a real need for better antipsychotic drugs. If the FDA agreed to approve any medication already approved by Europe (or to give it a very expedited review process), we could get an immediate windfall of dozens of drugs with unimpeachable records for almost no cost. Instead, in the real world, we’re cracking down on imported Canadian pharmaceuticals because the Canadians don’t have exactly our same FDA which means that for all we know they might be adding thalidomide to every pill or something. This is exactly the sort of silly anti-competitive cronyist practice that a principled intelligent libertarian could do away with.
2. Burdensome approval process for generic medications […] How come Martin Shkreli can hike the dose of an off-patent toxoplasma drug 5000%, and everyone just has to take it lying down even though the drug itself is so easy to produce that high school chemistry classes make it just to show they can? The reason is that every new company that makes a drug, even a widely-used generic drug that’s already been proven safe, has to go through a separate approval process that costs millions of dollars and takes two to three years – and which other companies in the market constantly try to sabotage through legal action. Shkreli can get away with his price hike because he knows that by the time the FDA gives anyone permission to compete with him, he’ll have made his fortune and moved on to his next nefarious scheme. If the FDA allowed reputable pharmaceutical companies in good standing to produce whatever generic drugs they wanted, the same as every other company is allowed to make whatever products they want, scandals like Daraprim and EpiPens would be a thing of the past, and the price of many medications could decrease by an order of magnitude. […]
3. Stop having that thing allowing companies to “steal” popular and effective drugs that have been in the public domain for years, claim them as their private property, shut down all competitors, and jack up the price 10x just by bringing them up to date with modern FDA bureaucracy.
4. Stop having that thing where drug companies can legally bribe other companies not to compete with them. I like this one because it sounds anti-libertarian (we’re imposing a new regulation on what companies can do!) but I think it’s exactly the sort of thing that the crony capitalists would never touch but which principled intelligent libertarians like O’Neill and Srinivasan might be open to, in order to bring more actors into the marketplace.
5. Stop thwarting consumer diagnostic products and genetic tests […] Srinivasan comes from the genetic testing world himself, so he’s likely to be extra sympathetic to this.