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Executive Summary

A lawsuit claims that Trump overstepped presidential authority.


A lawsuit has been filed arguing President Trump's "one in, two out" executive order to reduce government regulation is unconstitutional.

Public Citizen, along with the National Resources Defense Council and Communications Workers of America, filed suit Feb. 8 in US District Court for the District of Columbia arguing that the executive order exceeds presidential authority and "directs federal agencies to engage in unlawful actions that will harm countless Americans."

The groups want the court to rule the executive order cannot be implemented lawfully and prevent it from taking effect. A White House response is expected within 60 days, but no hearing has been set.

Trump issued the executive order Jan. 30, requiring that the cost of a new regulation be offset by elimination of two existing regulations. It is a concern for some in part because it could increase uncertainty and limit FDA's ability to provide industry with a framework on various subjects, but it also presents some opportunities for industry, stakeholders say. (Also see "Trump's Two-For-One Reg Order Needs Agency Interpretation, Medtech Reg Experts Say" - Medtech Insight, 30 Jan, 2017.)

The Office of Management and Budget issued clarifying guidance on the order Feb. 2 that appears to limit its application as it relates to FDA, however. (Also see "US FDA Could Be Mostly Spared From Trump's Regulation-Slashing Order" - Medtech Insight, 13 Feb, 2017.)

The suit states that federal agencies complying with the executive order would violate their governing statutes. In addition, it argues the executive order usurps congressional legislative authority and violates the presidential obligation to "take care that the law shall be faithfully executed."


Public Citizen's complaint does not mention FDA specifically, instead focusing on concerns about the order's effect on laws governing motor vehicle safety, clear air, occupational health and safety, and other areas.

"The public interest favors entry of a declaration that the executive order is contrary to law and unconstitutional because implementation of the executive order will deter, weaken, delay, and eliminate regulations that protect plaintiffs and the public from harm," the groups wrote in the suit.

White House spokesman Sean Spicer said during a Feb. 8 press briefing that the suit "is wildly inaccurate" and that everybody should welcome a review of regulations to make sure they are not stifling job creation. "[The suit] makes a ton of assumptions that call for speculation on what may or may not happen in the future," he said. "It's just subjective at best."


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