Issue 151
Welcome back to E&O Fridays, a paying subscribers-only weekly newsletter focused on the world of digital pharma products and FDA-regulated digital health.
E&O Fridays.
Here’s what’s going on in FDA-regulated and pharma-focused digital health:
- I’ll be back next week with an extra-long round-up. Today’s issue is focused on E&O’s newest long-form research report, Who Controls the Spice? The Inside Story of Apple’s 2018 De Novos. Paying subscribers can read the 7,000-word report on the E&O site right here or you can scroll down below for an excerpt.
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Who controls the Spice?
This is the inside story of how Apple timed its 2018 de novos in collaboration with the FDA — thanks to the Pre-Cert Pilot Program. Following a series of FOIA requests, E&O analyzed more than 17,000 pages of emails and other documents that Apple and the FDA exchanged between 2013 and 2019.
In December 2015, about 18 months before he became the Commissioner of the FDA, Scott Gottlieb MD wrote a column for Forbes entitled, “Why Apple Dumbs down Your Smartphone.”
Gottlieb argued that while Apple “advances the medical promise of its watch and smartphones,” the company has made clear that its “foremost aim” was not to “cross the lines that would class its new watch as a ‘medical device’ in the eyes of regulators.”
Gottlieb’s column was well-read both in digital health circles and on Capitol Hill. It’s also a prime example of a common refrain at the time that the FDA was holding back digital health innovation, especially from Big Tech companies.
Another go-to example for Gottlieb back then: In 2014, Google’s founders said that they wouldn’t move into health tech because of the regulatory burden in the US.
And, of course: 23andMe had its own infamous FDA avoidance strategy.
So, when Gottlieb became the FDA Commissioner in 2017, and the agency stood up the Pre-Cert program a few months later, the FDA’s relationship with Silicon Valley was set to change.
By the end of 2017, Pre-Cert attracted three Big Tech companies among its nine pilot particpants: Apple, Google/Verily, and Samsung.
And by the end of 2018, the FDA could announce that Apple, the biggest tech company in the world, now marketed two medical device products regulated by the agency.
Since then there has been less grumbling on Capitol Hill or in Forbes columns about the FDA restraining health tech innovations. On that political front, anyway: Mission accomplished.
Of course, the two de novos that Apple announced in September 2018 from the stage of one of their big product launch events were controversial. The official review time for one of the de novos clocked in at just 28 days. And Apple and the FDA had apparently coordinated the timing of the clearances to coincide with the date of Apple’s big event. Finally, questions arose about how Apple managed to keep the FDA from reviewing the hardware of its Apple Watch along with the two software as a medical device (SaMD) products.
More than three years later, questions surrounding Apple’s 2018 de novos remain largely unanswered.
In response to a series of Freedom Of Information Act requests to the FDA, Exits & Outcomes received more than 17,000 pages of emails and other documents that the FDA exchanged with Apple. The emails reveal:
- Surprisingly, it was Apple’s participation in the Pre-Cert program that enabled it to convince the FDA to create a novel regulatory pathway just for its two SaMDs.
- In March 2018 the FDA made it a goal to grant Apple its de novo clearances in time for the company’s launch event in September.
- Apple set up two shell companies that submitted the de novos on its behalf. Apple also code-named the two SaMDs “Spice” and “Caterpillar.”
- FDA officials verbally instructed some members of the review team (and possibly all members of the review teams) not to issue additional information letters as the September 1, 2018 deadline drew near, but instead make “decline” decisions that FDA managers would then be in a position to overrule days later.
Links to E&O’s reports, databases, newsletters
The Exits & Outcomes site is designed to make it easy to find long-form research reports, databases, and past newsletter editions. Click below for dedicated pages for each of those categories:
- Read through the long-form E&O research reports here.
- Search and sort the E&O databases here.
- Skim more than 200 past issues of E&O newsletters here.
