The two companies’ moves have gotten plenty of buzz. (The power of the iPhone alone guarantees that Apple’s strategy will be closely scrutinized.)
But is another tech company — Amazon — about to make its own important play for health care business?
There’s reason to wonder: Amazon executives recently held a meeting with top FDA officials, Darius Tahir reports in an interesting scoop for Modern Healthcare.
For now, details are sparse.
- Tahir reports that Amazon “leadership” met with FDA “leadership” one month ago.
- Only one official’s name is actually known: Howard Sklamberg, FDA’s deputy commissioner for global regulatory operations and policy.
It could mean nothing — the FDA might’ve been telling Amazon to clean up its messy prescription-drug market — or it could mean everything.
After all, when Apple executives privately met with FDA in 2013, it was a tip-off that Apple was planning to pursue the health care market. (A plan that will take effect when Apple unveils the iPhone 6 and iOS 8 in two weeks.)
What Did They Discuss?
No one from Amazon or the FDA was willing to divulge details of their conversations. But several industry observers spoke up to say the meeting suggests big moves ahead.
“It would seem to me that [Amazon] would be exploring changes in high-level policy,” Bradley Merrill Thompson, a lawyer at Epstein Becker Green, and a member of an FDA advisory panel, told Modern Healthcare‘s Tahir.
I also reached out to my colleague Ken Kleinberg, who helps lead health IT research at Advisory Board Company Advisory Board Company. What could Amazon and FDA possibly have discussed?
Kleinberg noted that FDA oversees many potential business lines that might be relevant to Amazon’s short-term plans and long-term planning.
“It’s a complex issue,” Kleinberg said. “There are FDA regulatory distinctions between manufacturing, marketing, and selling medical devices. There are regulatory distinctions between devices used for wellness, which often aren’t regulated, and ones used for disease management.”
“And in some cases, the device itself is not the issue — it’s how it is marketed.”
Several Possible Scenarios