Monday, July 6, 2015

April's Diagnostics Reform Plan Moves to Draft Legislation in June

In April, a coalition of stakeholders called the Diagnostic Test Working Group released a substantial plan for FDA reform (my short mid-April note here, including several key links to more information).

In June, the House Energy & Commerce workgroup, 21st Century Cures, worked to convert the essay-style proposal into draft legislation.  For example, actual legislation includes many conforming amendments that reconcile new parts of the FDA statue (if enacted) with older parts.  

Turna Ray at Genomeweb has published the second of two very detailed articles on the plan, the newer article dated June 17, 2015.  Available here (subscription only.)

Since the legislative draft language exists now, it is likely getting comments from some stakeholders but to my knowledge it has not been publicly posted yet.