FDA approves a new drug to treat Alzheimer’s disease, OSHA issues a rule to protect health care employees from COVID-19, and more…
IN THE NEWS
- The U.S. Food and Drug Administration (FDA) approved a new drug, Aduhelm, for the treatment of patients with Alzheimer’s disease, marking the first new treatment approved for Alzheimer’s since the approval of Namenda in 2003. FDA approved Aduhelm under an accelerated program that gives early approval to drugs that the agency deems to provide new benefits for the treatment of serious medical conditions. The majority of an FDA advisory committee previously voted that there was not strong evidence to support the effectiveness of the drug to treat Alzheimer’s. Patrizia Cavazzoni, director of FDA Center for Drug Evaluation and Research said that “the benefits of Aduhelm for patients with Alzeimer’s disease outweighed the risks” and that “the need for treatments is urgent.” Three members of the FDA advisory committee reportedly resigned following word that the FDA would approve the drug.
- The federal Occupational Safety and Health Administration (OSHA) issued an emergency rule outlining steps health care employers must take to protect their employees from COVID-19. The rule requires that these employers provide facemasks, screen non-employees who enter workplaces for COVID-19, and provide paid sick leave as needed for employees to get vaccinated. The rule only applies to settings that provide health care services and does not include locations where all employees are fully vaccinated. U.S. Secretary of Labor Martin J. Walsh said the new standard “follows the science, and will provide increased protections for those whose health is at heightened risk from coronavirus while they provide us with critical health care services.”
- The U.S. Supreme Court ruled that immigrants in a federal temporary protected status program who unlawfully entered the country are ineligible to apply for lawful permanent residence. The temporary protected status program allows individuals from certain countries designated by the government as having unsafe conditions to remain in the United States for humanitarian reasons. The Court unanimously held that lawful entry into the United States is a prerequisite for obtaining lawful permanent residence under the program. Oscar Chacon, executive director of Alianza Americas, emphasized that the ruling will increase the complexity of the application process for permanent residency for individuals in the program who entered unlawfully, but he did not expect it will change the underlying status of those granted protection under the program.
- The U.S. Environmental Protection Agency (EPA) and the U.S. Army announced their intent to update the Clean Water Act’s definition of “waters of the United States” to protect the United States’ water resources. President Biden directed the agencies to review the Navigable Waters Protection Rule, a rule created during the Trump Administration that limits federal protections of waters through a narrower definition of “waters of the United States.” After their review, EPA and the Army Corps have concluded that the Trump-era rule has led to significant harm to the environment. EPA Administrator Michael S. Regan said that “establishing a durable definition of ‘waters of the United States’” will “better protect our nation’s waters, foster economic growth, and support thriving communities.”
- The former Chief Judge of the United States Court of Appeals for the Second Circuit, Robert A. Katzmann, passed away at the age of 68. The current Chief Judge, Debra Ann Livingston, issued a statement for the court, noting that “Judge Katzmann led our Court through historic challenges, from budget sequester and governmental shutdowns, at the beginning of his tenure as Chief, to the pandemic which upended our Court’s operations only last spring. Throughout it all, Judge Katzmann provided sure and steady leadership.” In addition to his service on the judiciary, Judge Katzmann was a prolific legal scholar and political scientist whose books included Courts and Congress, Judging Statutes, Regulatory Bureaucracy: The Federal Trade Commission and Antitrust Policy, and Institutional Disability: The Saga of Transportation Policy for the Disabled. He was a past contributor to The Regulatory Review.
- President Joseph R. Biden issued an executive order revoking three executive orders issued by former President Donald J. Trump aimed at banning from app stores TikTok, WeChat, and other software developed or controlled by Chinese companies. President Biden’s order builds on an existing order that establishes criteria for evaluating software applications that may pose risks to national security. The new order also calls on the U.S. Department of Commerce to develop recommendations for protecting data on apps connected to foreign adversaries.
- The U.S. Department of Justice proposed new rules for firearms equipped with “stabilizing braces,” an accessory that helps shooters stabilize when firing with a single hand. The proposed rule states that at least two mass shootings have involved firearms with stabilizing braces. Everytown for Gun Safety, a gun violence prevention organization, praised the rule as a step toward closing the “arm brace loophole,” which the group alleges allows gun manufacturers to sell certain kinds of firearms without completing required additional checks. The Justice Department also issued model legislation alongside the proposed rule to assist states with creating rules that enable courts to remove firearms from individuals in crisis. The proposed rule and model legislation met several of the commitments that the Biden Administration announced to address gun violence.
- The U.S. Department of Transportation issued a reminder that owners and operators of pipeline facilities must plan to remove hazardous leaks and limit natural gas releases by December 27, 2021. Pipeline facilities must also address the detrimental effects of pipelines that are known to leak, such as cast iron or wrought iron pipelines. The Transportation Department seeks to limit methane emissions through these pipeline requirements. Acting Administrator Tristan Brown of the Pipeline and Hazardous Materials Safety Administration commented that pipeline facilities ought to address methane leaks to “protect the public and the environment.”
- The U.S. Fish and Wildlife Service (FWS) listed a North Carolina catfish as endangered and an aquatic salamander as threatened under the Endangered Species Act. The FWS also issued a rule that will create protections to conserve the threatened aquatic salamander. Furthermore, the FWS designated certain sections of North Carolina rivers as essential to the conservation of both the catfish and aquatic salamander. Scientist Tierra Curry at the Center for Biological Diversity praised the protective regulations, noting that the Endangered Species Act is the “most effective tool available to save plants and animals from extinction.”
WHAT WE’RE READING THIS WEEK
- In an essay contribution to the C. Boyden Gray Center for the Study of the Administrative State’s symposium celebrating the 75th anniversary of the Administrative Procedure Act, Professor Richard J. Pierce, Jr. of The George Washington University Law School discussed the agency adjudication process. Pierce identified issues facing the agency adjudication process, including the lack of protections from retaliation for administrative judges who may take actions that do not align with the views of the heads of their agencies. Pierce also presented possible solutions to improve the agency adjudication process, arguing that the optimal approach would involve expanding the use of the public notice and comment process, which allows the public to provide feedback on proposed rules. In addition, Pierce argued that paper hearings should replace oral hearings, which require fewer resources and have a higher likelihood of resulting in consistent outcomes.
- In a recent Brookings Institution report, Kelly Kennedy and Leana Wen recommended that the Biden Administration mitigate the risks of the recent Centers for Disease Control and Prevention (CDC) guidance to lift the mask mandate for fully vaccinated individuals. Kennedy and Wen argued that the Biden Administration should support vaccine verification efforts, release verification standards, and encourage public and private actors to maintain a mask mandate. Moreover, Kennedy and Wen argued that the CDC should clarify how the lifted mask mandate for vaccinated individuals will impact places where vaccinated and unvaccinated individuals are interacting. Finally, Kennedy and Wen argued that, although vaccinated individuals are largely protected from COVID-19, the Biden Administration should still encourage universal mask wearing so that unvaccinated individuals continue to wear masks as well.
- In a Harvard Environmental Law Review article, Cole Jermyn, recent graduate of Harvard Law School, explored challenges to adopting floating offshore wind technology in the United States. Jermyn explained that floating turbines are cheaper to manufacture than traditional offshore wind turbines built into the ocean floor, and they can be set in deeper waters with stronger and more consistent winds to generate more reliable power. Jermyn argued that the Advanced Research Projects Agency-Energy, a subagency of the U.S. Department of Energy, should increase research and development funding for floating turbines and that the Department of Energy should guarantee loans for these turbines. Jermyn also suggested that the Department of Energy and the U.S Bureau of Ocean Energy Management create a federally managed testing site for developers and agencies to test floating technology without having to obtain multi-year reviews or leases for projects.
- In an essay in The Regulatory Review, Grace Knofczynski, now an associate at Kellogg Hansen, explained Penn State Law Professor Dan Walters’s argument that the Administrative Procedure Act (APA)—which has reached its 75th anniversary today—is the best method for reviewing presidential inaction. Walters argued that the Take Care Clause of the U.S. Constitution, which requires the President to ensure that laws are “faithfully executed,” would be unworkable because courts would have to impose a specific definition of “faithful” to create a clear constitutional standard. Walters instead proposed that the APA’s more flexible standard allows courts the discretion to review extreme instances of presidential inaction while declining to review less important cases. Furthermore, Walters argued that the APA standard gives courts discretion to decline cases when the distinction between presidential action and inaction is unclear, as well as discretion in how much to defer to the President.