Medmarc Insurance Group
The Biden administration has wasted no time in issuing a number of executive orders (EOs), including those that applied a freeze to or revoked a number of orders issued under the Trump administration. Among these is an order designed to require a cost-benefit analysis of new regulations, but the net effect is to clearly signal that the relatively restrained regulatory approach of the past four years is over.
The Trump administration issued EO 13771 Jan. 30, 2017, only 10 days after President Donald Trump was sworn into office. This order, titled, “Reducing Regulation and Controlling Regulatory Costs,” required that U.S. government agencies repeal two existing regulations for every new regulation, and to do so in a manner that is at worst cost neutral to regulated entities. This order was the subject of a number of lawsuits, but was rescinded when President Joseph Biden formally withdrew EO 13771 in an EO dated Jan. 20, 2021. This was the date of Biden’s inauguration, signaling that the new administration would waste no time in leaving its imprint on the executive branch.
Public Citizen was among those who challenged EO 13771, although the lawsuit failed to gain the desired traction in court. In 2019, the U.S. District Court for the District of Columbia indicated that Public Citizen lacked standing to sue, not the first time this litigant failed to gain much traction in court.
Another of the repealed Trump era rules was EO 13891, the final version of which noted that the order was accompanied by a relatively short comment period of only 30 days. This order took up the question of good guidance practices, although the FDA has its own working set of standard operating procedures for guidance development. The FDA would have had to amend its approach to reflect the terms of the EO 13891, had the rule withstood the change of administration.
Another withdrawn entry in the Trump administration’s rulemaking agenda was EO 13892, which stated that enforcement discretion could be applied when the defendant could demonstrate there was no intent to violate the law. Another component of this executive order echoed the Brand memo to the extent that it disallowed the practice of using non-compliance with agency guidance in federal enforcement or prosecution.
Lack of Clarity on Several Issues
There are a number of other federal department/agency actions undertaken over the past four years that may be at risk. For instance, Merrick Garland, the nominee for Attorney General of the U.S., may decide that the Granston and Brand memos are due for revision or withdrawal, assuming the Senate confirms his appointment. Garland’s tenure at the U.S. Court of Appeals for the D.C. Circuit did not seem to include a large volume of cases involving the False Claims Act, but Sen. Chuck Grassley (R-Iowa) has indicated previously that he has misgivings regarding the use of the Granston memo to dismiss qui tam litigation. Thus, any Senate hearings for Garland’s appointment might not excessively press the jurist on his views of the Granston memo.
In a separate action, the White House posted notice that it would impose a regulatory freeze for any regulations that were recently published in final version in the Federal Register. The effective date for any such regulations is pushed back 60 days, while any draft regulations that did not reach final form are to be withdrawn.
There are exceptions to these two requirements, including instances in which agency or department directors make a compelling case for an exception, but the order also notes that guidance, not just rules, may be part of the freeze/review mandate. There is no indication as yet as to whether the Biden administration will address the August 2020 HHS order rescinding the FDA’s authority to regulate lab-developed tests, however, a question that may surface in the House as the VALID Act is inevitably resurrected on Capitol Hill.
For additional resources contact the Marketing department
Copyright © 2022 - Medmarc
Medmarc is a member of ProAssurance Group. The product material is for informational purposes only. In the event any of the information presented conflicts with the terms and conditions of any policy of insurance offered from ProAssurance, its subsidiaries, and its affiliates, the terms and conditions of the actual policy will apply.