[w1ntermute]

With respect to point #2, the real reason why revamping any regulatory regime "top to bottom" is difficult is because so much organizational, legislative, and administrative cruft has built up over the years in the federal government that means no one individual has the authority to drive reform. See FDA's discussion paper from Jan 2017 on revamping the LDT regulatory regime (https://www.fda.gov/media/102367/download) for more on the inane complexity created by the federal bureaucracy: "For example, a test made by a conventional IVD manufacturer would be regulated by FDA initially. If a laboratory made a significant modification to that test, it would then be regulated by CMS. If the original manufacturer then made another significant modification, the modification would be regulated by FDA."

Also: "In 2015, FDA established an Interagency Task Force on LDT Quality Requirements with CMS, the Center for Disease Control and Prevention, and the National Institutes of Health"

Any manager worth his/her salt can tell you that a task force involving four different agencies is unlikely to ever result in any meaningful change. A cornerstone of effective management is to designate one person who is responsible for execution and hold them accountable. This is exactly how the executive branch, from the president on down, is supposed to function (with oversight from the judicial and legislative branches, of course), but few parts of it are like that after centuries of bolting on overlapping agencies and departments.