FDA: We like innovation. Just don't mess it up

After an appearance before the U.S. House Energy & Commerce Committee, Dr. Jeffrey Shuren, director of the Food and Drug Administration's Center for Devices and Radiological Health, decided he should issue another communiqué clarifying his agency's position on innovation—this time on biotechnology company 23andme.

The genomics startup and the FDA have had a contentious relationship. In the fall of 2013, the startup company embarked on a national publicity campaign touting its tests' ability to tell individuals about their genomic code, and in particular, their risk for acquiring serious conditions such as cardiac disease or diabetes. That was an interesting strategy, as at that time, the startup did not have FDA approval and was still negotiating with the agency to receive it.

The FDA sent 23andme a warning letter, causing the company to shut down the portion of the genomics test designed to identify the most serious health conditions. That move raised the ire of the Silicon Valley community, which is sensitive to any curbs on its innovations. Fast forward to last Friday, when 23andme announced it had reached an accord with the FDA, and would seek clearance for a test to determine a certain inherited condition, which would serve as a prototype for future test submissions.

Nevertheless, the prior conflict was referenced during Tuesday's roundtable meeting with the House committee. In his blog post, Shuren reiterated his meeting statement, emphasizing that the agency believes accurate information is critical to the digital-health revolution. “FDA understands and supports people's interest in having access to their genetic information and believes such information can help them make more informed choices about their health, so long as that genetic information is accurate—that the results are correct, meaningful and written in a way that consumers can understand,” he said.

Shuren stated that incorrect information is not empowering to consumers, particularly if they are instructed to change a prescription dosage, or take other serious medical actions. Shuren cited a 2010 U.S. Government Accountability Office test, in which an investigator purchased genomics tests from four companies, which variably told him he had below-average, average, and above-average risk for prostate cancer and hypertension.

Shuren's blog is part of a long-running public relations campaign positioning the FDA as a friend to innovators– the agency seems to be trying to accommodate its critics while still retaining the ability to achieve its goals in the digital health sector. Earlier this year, for instance, the agency went on a cross-country road show with business executives and lawyers—from Baltimore to the Bay Area—to promote and explain its mobile medical applications guidance.

Follow Darius Tahir on Twitter: @dariustahir