James Boiani Quoted in “Proposed Theranos CEO Ban Ups Ante for Lab Testing Cos.”Law360 April 14, 2016
James A. Boiani, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Law360, in “Proposed Theranos CEO Ban Ups Ante for Lab Testing Cos,” by Sindhu Sundar. (Read the full version – subscription required.)
Following is an excerpt:
Records show that the CMS has pursued such bans in a handful of occasions in recent years, but it still remains a relatively unusual option for the agency. The CMS' inclination in this case toward what compliance attorneys consider a "death knell" to their clients shows an agency sharpening its oversight of new companies promoting and running tests that regulators have not yet fully evaluated, attorneys say.
"Getting ahead of agencies by discussing the benefits of a technology prior to working through the regulatory process, such as an FDA premarket review, irritates the hell out of regulators," James Boiani of Epstein Becker & Green PC said. "Because to their mind, you’re diminishing or circumventing the federal gatekeeper role in evaluating new tech and potentially giving consumers the wrong impression about where your product stands vis-a-vis federal standards."