There are some interesting parallels in the FDA’s recent action telling the firm 23andMe to “cease & desist” all marketing of its personal genomics test with the recent news about Jeff Bezos and the Amazon “delivery drones”. Both are new technologies which will require regulatory understanding and adaptation.
However, by contrast, Amazon has floated (figuratively & maybe literally…) the drone idea, launching public discussion and regulatory contemplation. By contrast, 23andMe blazed ahead. Brave? Hubristic? Both?
The FDA’s approach is almost always to prioritize the prevention of harm. Is there potential harm (like unnecessary prophylactic organ removal) from misinterpretation? Probably. Can it be mitigated? Surely, but the FDA will want to be part of crafting the solution if it’s potentially accountable for the potential harm.
My experience running an orthopedic device firm taught me that firms consult with the FDA retroactively at their peril. Even now it is surprising how few medical & wellness firms have a regulatory control process in place for public-facing web content and mobile apps.
What are the practical lessons here?
- Both are new technologies, which will require regulatory understanding and adaptation.
- Both are best served by proactive vs. reactive regulatory engagement
- Amazon has approached the regulatory environment more cleverly by “floating” its idea early.
- It’s possible to re-engage after facing regulatory problems, but more difficult.
- Inadequate or missing systems for regulatory content management is another area where many firms fail.
I hope 23andMe works things out with the FDA. It would have been far better to fully engage them earlier, but there is still hope.