Hacking FDA regulation for more gene mods

The first time I had a run in with the FDA was on accident. It was 2016 and I decided to genetically engineer brewing yeast to make them fluorescently glow. Buzzfeed did a story on the glowing beer and reached out to the FDA to get a comment. KTHNKS! No surprise, but the FDA didn’t like the fact that I was selling genetically engineered yeast to people. Something about an unapproved color additive. This is despite the jellyfish gene I inserted, Green fluorescent protein(GFP), has been extensively studied. GFP has literally been inserted into every cell of many different animals to no ill effects. Not to mention extensively consumed in beer by me and my friends. I disagreed with their decision and kept selling the product and they never enforced any restrictions. 

The FDA is weird like that, they probably have more discretion than any government agency to define their boundaries. This is also what makes the FDA one of the most complicated governmental agencies to work with, the process is inherently opaque. It’s why drugs can take around 10 years to get approved. It’s why the FDA only approves around 50 new drugs a year, most of which are just reformulations of old drugs. The FDA has slowed the pace of biotech innovation to a crawl. I look at all my tech counterparts just doing whatever the hell they want. Billions or maybe even trillions invested in faster GPUs, AI, robots and that one weird talking projector thing that you clip on your shirt. You can take risks in tech that you can’t in biotech because there is no regulation hedging and this folks, is why we don’t have the bioengineered future we all want.

In May 2024, the FDA released a guidance on the Heritable Intentional Genome Alteration of Animals to update us on how animals will be regulated. 1) Yes, the FDA regulates genetically modified animals even if they aren’t used for food 2) Yes, the use of the word intentional is intentional. As the founder of a company that genetically modifies animals, it was a bit disheartening to read this because these guidelines don’t really make sense. For instance, the reason for the use of the word intentional is that we have modern techniques like CRISPR that can replicate changes to DNA that would happen naturally. In case the FDA is reading this, understand, I love the FDA and all of this is a thought experiment, not real in the slightest but I could theoretically change the DNA of a cow such that no one in the world using any technique would ever be able to detect if the change was made intentionally or not. It’s still regulated because _intent_ . That's weird right? Why even go through the FDA then? Just out of the goodness of my heart? Because RULES? We possess genetic engineering technology that takes hundreds of years of evolution through natural breeding and condenses it into a single year. A technology so powerful it can change life itself. It can feed the world, fight climate change, make fuels, medicines and build fucking pokemon and we are sitting on it because for some reason intent matters. Imagine if every time someone wanted to release software that would be used by the public, it had to be screened by a government agency and that process took months or years. Where would we be?

I get it. Biology is different. But is it really that different? Is my GMO hamster really going to do more lasting damage on the world than Google Gemini? In no reasonable world is that possible. To me, this sets up an inherent adversarial relationship between biotechs and the FDA/regulation and we are beginning to see that play out, especially in the network state world. Companies have been slinging their biowares in other countries to test the market and avoid regulation. While I wouldn’t recommend sticking gene moded bacteria in your mouth that some rando with an MBA tells you will keep your teeth clean, nothing bad really happened when people did it. There are lots of crazy stories of crypto bros letting idiots inject them with shit that has no QC or safety profile and yet everyone is still alive. 

Oh god, I know this sounds so libertarian of me but we seriously need deregulation of biotech. So much of the talk in biotech circles these days is about regulation arbitrage. Companies with smart people and good ideas are constantly being slowed by the fact that sometimes it can take a month to just get an email response from the FDA. Want to actually do something? Well then it's going to cost millions of dollars to just file an investigational new drug application. Until regulation opens up, the pace of biotech advancement will be slow and that’s a tragedy. Not just because I want to see dragons in my lifetime but like people are dying and shit and we could actually be helping them.

So what to do? I don't think the answer is to do biotech in unregulated environments. There just isn't much appetite for that. I think people doing biotech just need to be more clever and versed in the regulatory framework so that it can actively be hacked and subverted while still staying in the realm of legal things. I think pushing boundaries of regulation will force the government to respond. In 2017, after I injected a CRISPR gene therapy in my arm and went viral on social media the FDA had to respond and their response was muted they basically said, “We can't do anything about this but we are against it.”

Same is true with Dr. He Jiankui who gene edited the world's first human embryos. They were not done with regulatory approval. He suffered more severe consequences and ended up doing jail/house arrest time. But also opened up the conversation and the possibilities and forced regulatory response.

There are other ways to hack the system. Looking for regulatory loopholes like the fact that if the FDA guidance above is written for “heritable” alterations. When it comes to drugs maybe companies could use the ability to actually provide drugs to people before approval but after an IND. Has anyone seriously combed through these regulations with the intent on getting around them and exploring the loopholes? We need to get on that.

We need more of this. If the system isn't going to change fast enough then it needs to be hacked. We need more people hacking the system. More people pushing these regulatory boundaries. Get the FDA to respond in weeks or months instead of years. We need to do this until they have no choice but to change things in a rapid way.

I truly believe in the future that the majority of boundary pushing in biotech will be without regulatory approval. Now it's just time for people to move forward and do it.