Bass, Berry & Sims attorneys Danielle Sloane and Courtney Ginn authored an article outlining the new FDA enforcement actions against laboratory developed tests (LDTs) that are marketed and sold directly to consumers. Although LDTs have historically been exempt from FDA regulation, as technology and testing options have developed and become more sophisticated, more regulation may be on the horizon for these types of tests. As Danielle and Courtney point out in the article, "[i]In late 2015 and early 2016, the FDA issued five warning letters to companies engaging in DTC [direct to consumers] marketing of LDTs. In several of these letters, it appears the FDA may be going beyond situations in which the consumer can order the test directly to also regulate situations in which the practitioner signing the order is affiliated with the laboratory."
The full article, "Marketing of Laboratory Tests to Consumers: Is a Practitioner Order Enough to Avoid FDA Enforcement," was published in the March 2016 issue of G2 Compliance Advisor and is available online (subscription required).