FDA Doublethink

Attending SynBioBeta I was able to rub elbows with a wide variety of people. From owners of large, successful companies to biopunks and science writers. (By rub elbows I mean walk past them because I was shy, FYI). A couple times the FDA was brought up, the first time by Josiah Zayner (I talked about his presentation and SynBioBeta here) and the second time was during an Unconference talk about human life extension. Zayner and the life extension group were not fans to say the least. Common trends were how the FDA was captured by drug companies, didn’t let people experiment on themselves, stifling cancer cures (so companies can profit off of continued treatments), and generally got in the way of these innovative thinkers.

During college I was lucky enough to take a graduate course in drug discovery. That course consisted of professionals in the drug field speaking at us while we messed around on our computers. The goal of the class was to teach us about the regulatory process of the FDA and as a mid-term/final project we presented a mock submission to the “FDA” panel staffed by the professionals who lectured to us. These professionals were middle and upper level management from companies like Eli Lily, Cook Biotech, and the institutional review board (IRB) of Indiana University (34-21, IU sucks, Boiler Up). The resounding opinions of these people was that the FDA was overly bureaucratic, required too much from companies, and stifled innovation with onerous regulatory hurdles.

So, here’s my question. If the FDA is bought and paid for by the drug companies, stifling DIY innovation to keep profits in big companies, helping suppress cancer cures, and getting in the way of innovative people. Why do the employees of those companies, who make innovative drugs, who work on cures for cancer, think that the FDA is a dumb, slow, inefficient bureaucracy?

Probably because the FDA is neither… and a little of both.

Is the FDA a dumb, slow, inefficient bureaucracy? Sure. Does it stifle innovation? Definitely. Captured By industry? No. Suppressing cures? Nope. Stifling DIY innovations? What DIY innovations are there to stifle?

My explanation for this double think is that the FDA is exactly what it looks like. A big government bureaucracy trying to “[protect] the public health by ensuring the safety, efficacy and security of human and veterinary drugs, biological products, and medical devices.” They are literally just a big group of scientists and experts trying to do exactly that.

To the DIY biologists out there, the FDA is this giant monolith bureaucracy. Its only interactions with them is to smite innovations like Gene Therapy and Glowing Beer. This is probably because the FDA doesn’t give a shit what Dr. Zayner is doing to his own body, just that he doesn’t sell kits to other people. If you want to go out and purify aspirin from a willow tree, go for it. I got $100 that says the FDA doesn’t care. I got another $200 that says if you try and sell it to other people they will become very interested. The FDA is there to regulate people who sell “drugs, biological products, and medical devices” not basement biohackers.

Remember that DIY therapy that made it through FDA clinical trials? No? Maybe because it became a company long before it started clinical trials. Mainly, because it costs a butt-load to fund drug development. A father working to save his children from pompe disease, founded a bio-tech startup that developed a treatment and was eventually acquired. This is what happens when you have a good DIY idea, you start a company and make money. (Great story and interview on The Tim Ferris Show podcast, recommended)

Now to smash some myths about the “captured” FDA.

Did you know the FDA regulates all ad material published or said about every drug? (Captured FDA FAQ) Its almost like the “captured” FDA is lulling us into a false sense of security.

Did you know drug companies pay a fee when they submit an application? Did you know those fees added up to a little more than $3 million in 2016 and around $2.75 million 2017? (link) Definitely a feature the pharma overlords forgot to remove, should let the US government cover the bill.

Guess how much companies spend developing a drug to sell to consumers? Hint: Its higher than the number in your head. $648 million according to a recent analysis. Except that analysis has some serious flaws and it’s more like $2.7 billion. (Forbes, Fav drug blog) “Captured” FDA should really help do something about that.

What percentage of drugs make it through the “captured” FDA clinical trials? 10% (FDA, Interpretation) and in drugs that have made it to the last trial? 40% fail. The “captured” FDA should really lower the bar. Drug company profit margins are way too thin. (okay, I wrote that, then looked it up and I was way wrong. Paper, BBC. But I think this is an effect of monopoly/drug pricing and maybe a little survivorship bias)

Did you know the “captured” FDA forces drug companies to put warning labels on their products? Did you know that one of these black box warnings “caused” a share price to drop by 12.95% (business insider). That’s about $5 per stock and there are 1.6 billion shares. So, they lost $8 billion in value. Nice job FDA. Here, is a probably incomplete list but geez, 7 black boxes in 2017, 5 in 2016, and 14 in 2015. Does captured mean what I think it means?

Even more damning for the “captured” FDA. Why do generics exist at all? Of Amgen, Eli Lilly, and Pfizer; only Pfizer sells generic drugs. The “captured” FDA even has onerous rules regarding patent term restoration, only 60 days to apply, no more than 14 years of eligibility, basically garbage.

Does the FDA have problems? Yes, definitely, like I’d have to write another 1010 words just to list them all. But is it “captured,” I don’t think so.

During that class I mentioned at the beginning. They told us firsthand what the drug submitting process is like and this is what I took away. First you fly out from an airport not in the town your company is based in. This is to avoid corporate espionage. You wear no branded clothes, no branded notebooks, or bags. When you arrive in Maryland you go straight to the hotel, the next day you go straight to the FDA headquarters where you sit in a waiting room with your corporate competitors in silence. This is to avoid corporate espionage. When your group is called you go into a meeting room. You spend the next few hours scribbling furiously as you and the FDA talk about the several hundred pages of file you sent them months ago. You saying nothing that isn’t answering the previous question. This is like being deposed but instead of jail time, billions of dollars and your job are on the line. You and the FDA “agree” on terms, requirements of trials, labeling, or the shape of a pill. When the meeting is over you go straight to the hotel and debrief the team. You all compare your notes and agree on phrasing. You leave the hotel, fly back to the airport not in your home town, and drive back to your headquarters. At work for the next several days, you compile notes, write out the list of demands the FDA has made and send it back to the FDA for them to agree to. Most of the time they have more demands, you don’t get to say no. This is what the FDA feels like to corporate drones that must interact with it.

Is the FDA a dumb, slow, inefficient bureaucracy? Yes, that’s how bureaucracies work. That’s what protects people and make sure companies aren’t giving you poison.

Does it stifle innovation? Yes, that’s the price we pay for safety. Other industries I would like to stifle: viral warfare, self-replicating nanobots, pissed-off AIs, and the My Little Pony franchise.

Does the FDA suppress or help suppress cures? Not really, there are awards for companies that develop Orphan Drugs or treatments for Rare Pediatric Diseases. If you think drug suppression is anything but a conspiracy theory, remember Steve Jobs died of cancer and was worth $31.6 billion dollars.

To the DIY biologists, the FDA is a distant island, communicating with other island companies with expensive yachts, trading secrets, and keeping the little guys out. The FDA is forever unreachable until they send shore parties to harass the biologist that tries to sell proteins or DNA.

To the industry, the FDA is the DMV. Everything takes too long, there is too much paperwork, and you need to pay weird fees just to be there. Once you finally get your license, you only get a couple of years to drive before other people start using the car you paid for. Not to mention, sometimes the FDA just takes away your car if your car is a little fuel inefficient, or doesn’t have the right turn signal timing.

The FDA is bureaucracy, grey, monolith, boring bureaucracy. They try to keep you safe, and seem to be doing pretty well. Learn to love them.


NSFW version:

Copy this into your text editor, find and replace (Ctrl+H) in the first box write “captur” and in the second put “cuck”. Then click “Replace All,” totally worth the cheap laughs.

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