On July 22, “Amazon leadership” met with Howard Sklamberg, the agency's deputy commissioner for global regulatory operations and policy, and “various FDA leadership,” according to the agency's public calendar. The FDA declined to provide details beyond the information on the calendar. Amazon has not responded to a request for comment.
Google reportedly met with the agency to discuss its plans for a contact lens that could sense a patient's glucose levels through tears. Apple reportedly advanced its plans for its HealthKit application and iWatch smartwatch in an FDA meeting. According to a report obtained through the Freedom of Information Act, Apple claimed it “may have a moral obligation to do more” in the healthcare space.
Experts surveyed anticipated Amazon's requests and plans—whatever they may be—to be big. “It would seem to me that they would be exploring changes in high-level policy,” Bradley Merrill Thompson, a lawyer at Epstein Becker & Green, and a member of a panel that advised FDA on health information technology regulations, wrote in an email. Thompson said Sklamberg is a high-ranking official with broad responsibilities, including drug policy and FDA's field force, which might indicate the breadth of Amazon.com's interests.
The meeting might have “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,” Thompson speculated. “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.”
Dan Haley, a vice president for government and regulatory affairs at cloud-based electronic health records firm Athenahealth, speculated that Amazon might have an interest in wearables or mobile health, given its recent introduction of a smartphone.
Amazon is already involved in healthcare. Mike Payne, head of medical affairs at startup Omada Health, said Amazon's cloud computing services, Amazon Web Services, was an “incredibly big part of the growth of our business,” once it certified as being compliant with Health Insurance Portability and Accountability Act regulations. David Shaywitz, chief medical officer for DNAnexus, agreed.
However, Paul Misener, Amazon.com's vice president for global public policy, previously testified on Capitol Hill that his firm finds HIPAA-compliance burdensome. But HIPAA is not an FDA matter, so it's unlikely that was under discussion.
Another potential conversation between the FDA and Amazon might involve pharmaceuticals. Dr. Ford Vox, writing for Slate, has criticized Amazon.com in the past for serving as a marketplace for prescription drugs, and testified for the FDA to assert its jurisdiction to ensure Amazon didn't sell such drugs in the future.
Follow Darius Tahir on Twitter: @dariustahir