Amazon's FDA Meeting Signals Big Healthcare Plans
By Jof Enriquez,
Follow me on Twitter @jofenriq
Amazon recently met with officials from the U.S. Food and Drug Administration (FDA) to possibly talk about how the agency’s regulatory powers can affect both the company’s existing and potential healthcare products and services.
Unnamed “Amazon leadership” met with the FDA’s deputy commissioner for global regulatory operations and policy, Howard Sklamberg, and various other FDA leadership officials on July 22 and discussed undetermined matters, according to a report in Modern Healthcare.
Speculation abounds as to what the topics of conversation included, but the report suggests that Amazon may be clarifying with the FDA on how existing rules can be tweaked to better market future products in the healthcare space.
“It would seem to me that they would be exploring changes in high-level policy,” Bradley Merrill Thompson, a member of an FDA advisory panel, wrote in an e-mail to Modern Healthcare. The meeting might have had “something to do with the retail distribution of FDA-regulated products, and that the company needs some sort of change in policy to do whatever it is they have in mind doing. Amazon is always so creative that they tend to enter markets in a big way, disrupting existing business models. It will be fascinating to see whatever they have in mind.”
While Amazon already has Amazon Web Services — which hosts electronic health records (HER) — it could be planning to make a bigger splash in healthcare.
In the same report, Tahir cites Dan Haley, VP of government and regulatory affairs at EHR vendor Athenahealth, as speculating that Amazon could soon introduce wearables and mHealth services. Amazon could also be talking to the FDA about online pharmaceutical sales on its platform, the article said.
Ken Kleinberg, who helps lead health IT research at Advisory Board Company, told Forbes that selling medical devices could be in Amazon’s plans, but the company needs to consult the FDA before diving in.
“It’s a complex issue,” said Kleinberg. “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.”
Meanwhile, MobiHealthNews speculates that “one possible reason for the meeting is that Amazon is considering a HealthKit-like functionality for future updates” of its recently-launched Fire Phone device.
HealthKit, a health data aggregator app built into the upcoming iOS8 and iPhone 6, has been discussed by Apple Inc. and FDA officials previously, according to Modern Healthcare. Another Amazon rival, Google, had also talked with the FDA regarding its healthcare plans, specifically about its smart contact lens that can measure glucose levels in tears.
The expanding list of tech titans talking to the FDA underscores the opportunities that lie in the healthcare industry, especially for an online retailer like Amazon.
“The potential market is huge,” Kleinberg told Forbes.