Thanks for writing this and wholeheartedly agree on the transparency making the industry more effective across the board. The result is better designed drugs and trials for patients. FDA feedback should not be part of a competitive advantage of a drug company. Regulatory uncertainty and ambiguity is something we should be fighting against not for. Also people really underestimate just how much data and insights lie in ct.gov for designing trials.
One phrase I keep reacting to is “increasing competition.” I understand the policy argument, but emotionally it can sound like this is about one company losing advantage to another.
The more direct frame, to me, is that failed submissions contain hard-won learning. When that learning stays private, other teams repeat avoidable mistakes, trials take longer, capital burns down, and patients wait.
This is especially painful for smaller biotechs, where one regulatory misread can be the difference between getting another shot and running out of funding.
So yes, protect truly proprietary information. But FDA’s reasoning should not function like private case law available only to companies that have already paid the tuition.
And we may not need to wait for the government to solve all of this. Sponsors, advisors, and operators could start donating redacted FDA correspondence themselves, in the same spirit as CTD Commons. Let companies redact what they need to protect, but share enough of the regulatory reasoning that others can learn.
The goal is not “competitors win.” The goal is fewer repeated failures, better prepared submissions, and more drugs reaching real people faster.
Thank you for this post, which illuminates not just the topic of drugs and biologics, but also sheds some light on my sector, the medical device industry.
I'm new to thinking about policy in a sustained way, and new to Substack, so thanks for providing such a constructive example of the kind of analysis and discussion that's possible here!
An interesting corollary to this is that those burdened (big pharma) and benefitting (startups) from added disclosure are different groups, mostly.
Regulatory obscurity can be an excellent barrier to entry, and big pharmas already have large libraries of prior FDA interactions to mine for insights (especially using AI nowadays). Not so for startups.
I feel like "burdened" isn't the right way to put it. Big pharma company A should still gain insight from CRLs of big pharma company B. I think all drug developers will benefit, just starts ups more so than big pharma
Thanks for writing this and wholeheartedly agree on the transparency making the industry more effective across the board. The result is better designed drugs and trials for patients. FDA feedback should not be part of a competitive advantage of a drug company. Regulatory uncertainty and ambiguity is something we should be fighting against not for. Also people really underestimate just how much data and insights lie in ct.gov for designing trials.
Really thoughtful piece.
One phrase I keep reacting to is “increasing competition.” I understand the policy argument, but emotionally it can sound like this is about one company losing advantage to another.
The more direct frame, to me, is that failed submissions contain hard-won learning. When that learning stays private, other teams repeat avoidable mistakes, trials take longer, capital burns down, and patients wait.
This is especially painful for smaller biotechs, where one regulatory misread can be the difference between getting another shot and running out of funding.
So yes, protect truly proprietary information. But FDA’s reasoning should not function like private case law available only to companies that have already paid the tuition.
And we may not need to wait for the government to solve all of this. Sponsors, advisors, and operators could start donating redacted FDA correspondence themselves, in the same spirit as CTD Commons. Let companies redact what they need to protect, but share enough of the regulatory reasoning that others can learn.
The goal is not “competitors win.” The goal is fewer repeated failures, better prepared submissions, and more drugs reaching real people faster.
I like your thinking!
Thank you for this post, which illuminates not just the topic of drugs and biologics, but also sheds some light on my sector, the medical device industry.
I'm new to thinking about policy in a sustained way, and new to Substack, so thanks for providing such a constructive example of the kind of analysis and discussion that's possible here!
"it would be very surprising to me if more regulatory transparency reduced innovation on net"
hmm, i hadn't considered this perspective before, but I do see how it can apply to other instances (eg employee pay transparency)
great read!
An interesting corollary to this is that those burdened (big pharma) and benefitting (startups) from added disclosure are different groups, mostly.
Regulatory obscurity can be an excellent barrier to entry, and big pharmas already have large libraries of prior FDA interactions to mine for insights (especially using AI nowadays). Not so for startups.
I feel like "burdened" isn't the right way to put it. Big pharma company A should still gain insight from CRLs of big pharma company B. I think all drug developers will benefit, just starts ups more so than big pharma
Intresting question!!! And very difficult.