Attorneys’ 4 Predictions for FDA in 2016

Several Wilson Sonsini attorneys say they expect FDA to begin regulating high-risk laboratory-developed tests (LDTs) early this year. Writing in an online blog post, they say this move will be contentious and that they expect court challenges to the agency’s regulation. “FDA’s regulation of LDTs has the potential to reshape a significant portion of diagnostic testing industry landscape,” they say.

After reviewing key FDA developments in 2015, the attorneys make three additional predictions for 2016:
         Congress may grant regulatory exclusivities to diagnostic tests, which are the cornerstone of personalized medicine;         FDA, along with the Justice Department and state attorneys general, will continue enforcement actions against companies, with an increased focus on individuals, including CEOs of regulated companies; and         orphan drug approvals will continue to increase.