Language barrier
Silicon Valley struggles to speak FDA’S lingo
WASHINGTON — From Apple’s new smartwatch that tracks heartbeats to Google’s contact lenses that measure blood sugar — Silicon Valley is pouring billions into gadgets and apps designed to transform health care. But the tech giants that have famously disrupted so many industries are now facing their own unexpected disruption: regulation.
Google co-founder Sergey Brin expressed his frustration with the complex web of rules that govern the field.
“Health is just so heavily regulated,” Brin told industry executives in July. “It’s just a painful business to be in.”
Still, tech entrepreneurs are pumping money into efforts to reshape health care, a $2.7 trillion market. Venture capital funding for companies in the digital health space surpassed $2.3 billion in the first half of 2014, more than the $1.9 billion raised in all of 2013, according to venture firm Rock Health.
But before tech companies can turn America’s smartphones into portable medical suites, they must meet the rigorous standards of the Food and Drug Administration. It’s not hard to find the source of the clash between freewheeling Palo Alto and buttoned-down Washington.
Apple CEO Tim Cook talks about the health and fitness aspects of the Apple Watch in Cupertino, Calif. As Silicon Valley turns its attention to health care, the giants of the tech world — who have famously disrupted so many industries — are now encountering their own unexpected disruption: regulation. MARCIO JOSE SANCHEZ/ASSOCIATED PRESS
“This is a culture war,” said Steve Grossman, a longtime FDA consultant to companies. “Silicon Valley is used to just bringing their products straight to the market and any regulatory scheme that involves scrutiny and delay is alien to them.”
Tech companies have tussled with Washington before over issues like online privacy and intellectual property. But never before have they had to submit products for review before they can launch.
Some experts say the process is so burdensome that tech entrepreneurs are shying away altogether. “They look at the environment and the expenses and the cost of navigating it and just say, ‘To heck with it,”’ said attorney Colleen Klasmeier.
The FDA says it is uninterested in regulating the vast majority of the 24,000 medical apps available for download, most of which perform simple tasks like tracking calories or helping manage prescriptions.
But last year, the FDA said it would start regulating apps and gadgets that collect or track medical information as medical devices. Before a product can launch, the company must show it provides safe, accurate information. For example, an app that uses an attachment to check for irregular heartbeats must go through the same FDA review as a traditional heart monitor.
FDA stresses its guidelines are “nonbinding,” and that manufacturers should “engage in early collaboration meetings with the FDA” about how their technology will be regulated.
Google and Apple declined to be interviewed for this story, but a government memo outlining an FDA meeting with Apple last December shows the company pledged to “work closely with FDA as they develop future products.”
People who have spent time in Washington and Silicon Valley say the distance between the two worlds isn’t insurmountable. Bob Kocher of Palo Alto venture firm Venrock says tech companies are simply not in touch with the experts who know how to navigate regulation.
“The advice is harder to come by out here because they don’t know who to talk to,” says Kocher, who previously worked in the Obama White House.
A handful of startups have successfully brought health technology to market by cooperating with regulators. The FDA has approved 100 medical apps, including 40 in the last two years.
Among them is Alivercor, which sells a handheld device that attaches to a smartphone to detect dangerous heart rhythms. The company submitted its FDA application in August 2012 and received clearance four months later. The company’s CEO, Euan Thomson, says tech industry people exaggerate the difficulties of regulation because they don’t understand it.
Genetic testing company 23andMe became the poster child for tech’s dysfunctional relationship with Washington last November, when the FDA ordered the company to stop selling its health tests.
In a warning letter, the FDA said despite “hundreds of e-mail exchanges” the Google-backed company failed to demonstrate the effectiveness of its saliva-based kit, which claimed to tell customers if they were at risk for more than 250 health conditions and diseases.
Since then, 23andMe has brought in four executives experienced in the drug and medical testing fields. The company’s CEO, Anne Wojcicki, compares the process to doing business in a foreign country.
“You need to understand that language and the way that they do business there almost in the same way you would going into China or India,” she says.