The title says it: if you’re involved in drug or medical development and have experienced the FDA’s torpor, or vengeance, consider getting in touch; anonymously is fine. I want to make explicit something a few people caught in “I am dying of squamous cell carcinoma, and the treatments that might save me are just out of reach:” many of the people with first-hand knowledge of the costs of the FDA’s slowness don’t want to speak out about it, even anonymously. They’re justifiably worried about their lives and careers, as well as what appears to be the FDA’s penchant for punishing companies or individuals who criticize or want to reform it. So the people who know most about the problem are incentivized not to speak up about it, kind of like the way mafioso were discouraged from discussing what they knew for fear of retribution. Some of them will talk about their experiences and knowledge over beer or coffee, but they won’t go further than that.

There are reform efforts and at least three serious people I now know of who are working on books about the invisible graveyard that I’m likely to join soon—and perhaps become a mascot for: a million deaths are a statistic but one is a tragedy, as they say. If the life and death of one man can stand for the millions who have died, maybe people will pay more attention. So if you have any direct experience that you’re willing to share, including anonymously, consider doing your bit for reform.

Some of that experience might include:

* General FDA slowness and lack of responsiveness.
* The sense of vendetta—that criticizing the FDA in public, especially over specific decisions, will lead to retribution later.
* Patients who wish to try drugs but can’t.
* Scientists, doctors, or companies that deliberately slow down what they’re doing.
* Whatever else I might be missing.

Many observers are aware of these problems but also the extent to which many people with rich specifics are reluctant to share those specifics, for good reason. I will respect anonymity and am aware of people working on projects designed to help FDA reform—and, hopefully, to save the lives of people like me, who are suffering from maladies that are likely curable with existing technologies, if the FDA made those technologies legal to consistently test and try, and if the FDA worked harder to make the existing trial process faster, easier, and more transparent.

The FDA situation is a specific example of the country’s love of process and bureaucracy, rather than a love of effectiveness and success. We’re suffering from huge bureaucratic drag in doing anything; we see the same general problem recur in building out subways or other forms of transportation infrastructure, in building new electricity transmission lines, in permitting new electrical generating capacity, in building new housing, in the Nuclear Regulatory Commission (NRC), and in the FDA. Works in Progress is a good publication covering these kinds of issues. We’re stuck with the sclerotic processes implemented in the ’70s instead of the dynamic, transparent, and far faster processes we should have today. We’re all suffering the results, some of us more acutely (like yours truly, who is doing for lack of large-scale, deployed, and debugged customized vaccine technology) and some of us less directly.

Anything that is small enough to build in a factory and ship via container is cheap and abundant; anything that requires opaque regulatory approvals or that goes into the body is expensive and tragically scarce. Ezra Klein and Derek Thompson are writing a book presently titled Abundance: What Progress Takes, which is about this subject and which I’d write about if I were likely to last until April 2024.

Practitioners on the ground, like doctors, see the deaths of their patients. The FDA is more concerned about political issues. There’s nothing like watching people die to alter your risk tolerance.