But despite the perceived split, the agency is—haltingly and incompletely—accommodating some of its California antagonists’ wishes. Not that you’d necessarily know it from the tone Silicon Valley uses. Balaji Srinivasan, a general partner at prominent Silicon Valley venture capital firm Andreessen Horowitz, often takes to Twitter to air his complaints about the agency, culminating recently in an eight-tweet series of examples needling the agency for its failure to move quickly, particularly for approving new sunscreens and anti-obesity pharmaceuticals.
Industry analyst David Shaywitz says Srinivasan’s tone is shared by many, citing Bill Gurley, a venture capitalist who invested in OpenTable and Uber and who is interested in healthcare, but won’t pull the trigger on many investments: “He’s really looking hard for opportunities in this space, but he’d like one that doesn’t involve messy clinical studies or regulatory involvement.”
“That’s pretty definitional for this space,” Shaywitz deadpanned. “Some folks in Silicon Valley say the healthcare system is so calcified that the only way (to go) is to completely go around the system and massively reinvent everything.”
Shaywitz has some sympathy with that view, arguing that healthcare regulations often protect incumbents at the expense of new entrants because of a “risk aversion” from regulators.
And yet, despite that risk aversion, FDA has been deregulating the field—both officially and unofficially.
Officially, you can see the deregulation in actions like Friday’s draft guidance exempting medical-device data systems from regulation entirely. Three years ago, the systems were considered high-risk products. The official relaxing of regulations can best be seen in the recent draft framework regulating health IT, which foreswore FDA oversight over electronic health records, most clinical decision-support systems and many other fields.
Unofficial deregulation activities are just as interesting. A January 2013 study in JAMA Dermatology found that readily available apps claiming to diagnose melanoma based on pictures of moles were often incredibly unreliable. And there are more. Last December, at the mHealth Summit, a questioner asked Jeff Shuren, the director of the Center for Devices and Radiological Health at FDA, whether the agency intended to do anything about questionable healthcare apps, noting that he could download one that claimed to cure stomach ulcers through phone vibrations.
Shuren responded that, “We actually have been taking enforcement action … It doesn’t serve patients well if there are those kinds of technologies out there; it’s the modern-day version of snake oil.”
But the FDA’s actions have been fairly limited. The FDA pursued action against an Indian firm, Biosense Technologies, because its uChek app claimed to measure several metrics, such as glucose and bloody urine, through urinalysis without the proper clearance. But that was after a trade journal, the Gray Sheet, pointed it out.
And FDA hasn’t taken action, for example, against the numerous illegal prescription-drug sellers on Amazon.com, a Slate article has revealed.
The most prominent Silicon Valley-style company to feel the sting of FDA oversight is probably 23andMe, which was the recipient of an FDA warning letter chastising the firm for marketing genetic tests linked to serious health conditions. Company founder Anne Wojcicki has said, that after receiving the letter, “I felt slapped in the face from out of left field.”
Perhaps FDA’s inconsistency with digital health was what made it so surprising, but the FDA warning letter made it clear the firm and the agency had been in discussions since 2009 to get the firm the proper clearance. Nevertheless, 23andMe pressed on with a national TV campaign advertising its most serious diagnoses..
Still, the firm has submitted to the FDA’s system. It announced last Friday that it would be pursuing clearance for a single test, linked to the inherited condition Bloom syndrome, calling it an “important step in our work” and that it would help “establish the parameters for future submissions.”
That inconsistency and uncertainty is what drives critics of the agency, even when they acknowledge their approval of certain decisions. Dan Haley, a vice president of government and regulatory affairs with Athenahealth wrote in an e-mail that the medical-data-device-systems guidance illustrates a broader concern.
“We like the direction,” he wrote, but “substantial revision … illustrates just how tenuous is the ‘certainty’ afforded by nonbinding guidance. And the ability to revise in a positive direction presupposes the opposite.”
That’s why Haley supports legislation like the Preventing Regulatory Overreach to Enhance Care Technology Act, or PROTECT Act, and Sensible Oversight for Technology which Advances Regulatory Efficiency Act, or SOFTWARE Act, which he argues will codify future expectations for entrepreneurs, and that’s why all eyes will be on the Energy and Commerce Committee Tuesday, and in the future, as the center of efforts to make those changes.
Follow Darius Tahir on Twitter: @dariustahir