We have seen over recent years agency disregard for the Congress since it has become so polarized.
We now see a comparable dismissive attitude directed to the Courts possibly as result of a number of 5/4 decisions by the Supreme Court or more likely as a result of the new emphasis on using agency administrative powers to their fullest.
Consider this chain of events.
A plaintiff seeks relief in the court claiming that the agency had no authority to issue a rule. See 304bcomplaint (340b)
The Court opines in no uncertain terms that the agency did not have the authority to issue the rule. See 340b 304bpiorder
The agency responds by issuing an interpretative rule which renders moot the decision of the court. http://www.hrsa.gov/opa/programrequirements/interpretiverule/interpretiverule.pdf
The FR notice announcing the availability of the rule is here, https://www.federalregister.gov/articles/2014/07/23/2014-17409/availability-of-interpretive-rule-implementation-of-the-exclusion-of-orphan-drugs-for-certain
We encourage our readers to review the aforementioned material and hopefully we have overreacted. However if we are correct in our analysis then one need not only be concerned about the onslaught of “midnight regulations” likely to occur beginning in the Spring of 2016, but possibly the Fall of 2015, but the immediate reinforcement of “regulation by executive order” by trend setting refusals to implement the decisions of the judiciary.
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