Executive Orders

As discussed in our previous post, multiple federal courts have issued preliminary injunctions blocking the Biden Administration’s COVID-19 vaccine mandate for employees of federal contractors.  On January 27, 2022, the United States District Court of Arizona issued a new and additional injunction barring enforcement of the mandate within the State of Arizona.  In so doing, the Arizona court added to the injunctions previously issued by the U.S. District Courts for the Eastern District of Kentucky, Western District of Louisiana, Eastern District of Missouri, Middle District of Florida, and Southern District of Georgia.

The Georgia injunction is the only one of the rulings that applies nationwide.  Like the Arizona injunction, the Missouri, Florida, and Kentucky injunctions are limited to specific states (collectively, Kentucky, Ohio, Tennessee, Missouri, Nebraska, Alaska, Arkansas, Iowa, Montana, North Dakota, South Dakota, Wyoming, and Florida).  The Louisiana injunction is also limited, but its limitations are based on entities rather than geography; it applies to contracts and other agreements between the federal government and the governments of Louisiana, Mississippi, and Indiana.  The Biden Administration has appealed these earlier decisions; we expect that an appeal of the Arizona decision to the Ninth Circuit will likewise be forthcoming.

At the same time, the Biden Administration’s other primary COVID-19 initiative for large employers — the vaccination and testing emergency temporary standard issued by the Occupational Safety and Health Administration (the so-called “OSHA Mandate”) — was stayed by the United States Supreme Court on January 13, 2022.  In the wake of that decision, OSHA announced on January 25, 2022 that it is withdrawing the enforceable emergency temporary standard.

While the Supreme Court’s decision halted immediate application of the OSHA Mandate, the emergency temporary standard qualifies as a proposed rule for purposes of OSHA’s notice-and-comment rulemaking process under 29 U.S.C. § 655, and OSHA has announced that it will continue to consider the emergency temporary standard pursuant to that process.  Accordingly, OSHA could attempt to promulgate a final rule (as opposed to an emergency temporary standard) that addresses vaccines or testing requirements.

The rest of this post consists of (1) an overview of the Arizona decision regarding the federal contractor vaccine mandate; and (2) an update on the status of the other challenges to the federal contractor vaccine mandate, including the Kentucky, Louisiana, Missouri, Florida, and Georgia litigations.Continue Reading COVID-19 Vaccine Mandate Update: Arizona District Court Issues Additional Injunction; Mandate Remains Enjoined Nationwide; OSHA Mandate Withdrawn

Last week, President Trump issued an executive order aimed at encouraging the expansion American manufacturing of essential medical products — Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (August 6, 2020) (the “Order”).  The Order sets forth an ambitious plan requiring extensive agency action on a tight timeline that suggests a significant impact.  Closer examination of the Order raises significant questions about the practicalities of implementation and the realistic impact of the Order once the substantial stated exceptions are taken into account.

The List

The heart of the Order is a list of Essential Medicines, Medical Countermeasures (“MCMs”), and Critical Inputs to which the Order’s requirements apply — but the key components of this list do not yet exist.  Instead, the Order directs the Food and Drug Administration (“FDA”) to produce the list within 90 days and to include on the list Essential Medicines, MCMs, and Critical Inputs “that are medically necessary to have available at all times in an amount adequate to serve patient needs and in the appropriate dosage forms.”

The Order provides the following definitions that give some insight into what may be on the FDA’s eventual list:
Continue Reading Trump Administration Increases Uncertainty for Pharmaceutical Manufacturing

A new administration will often articulate its approach to the management of executive agencies through the issuance of an executive order.  President Clinton issued E.O. 12866 in the fall of 1993 and set forth both the process of regulatory review and a regulatory philosophy meant to guide executive agencies.  E.O. 12866 placed an emphasis on cost-benefit analysis and data with which the Office of Information and Regulatory Affairs (“OIRA”) was to review agency action.  President Obama, less than two weeks after taking office, announced his intent to adhere to the “fundamental principles and structures governing contemporary regulatory review set out in Executive Order 12866.”  The reinstatement of E.O. 12866 and eventual issuance of the substantially similar E.O. 13563 foreshadowed the Obama Administration’s focus on data and analysis principles that often resulted in industries submitting an ever-increasing amount of information to executive agencies.

A great deal of attention has been placed on agency regulation by President Trump, who has vowed to cut corporate-focused regulations by “75 percent – maybe more.” Although President Trump has yet to release an official approach to managing the administrative state, the new Administration has taken initial steps that seems aimed at reducing regulations.  Further, Congress has taken up the mantle of deregulation by passing two measures in the House that could severely hamper agencies wishing to issue major rulemaking.  However, without an articulated policy of managing executive agencies, it is unclear whether these measures would actually reduce regulation, or simply shift agency focus from major rulemaking to major guidance, leaving industries without a clear sense of the new playing field.
Continue Reading Reining in Regulation: New Year, New Administration, New Confusion