Week in Review

IN THE NEWS

• The U.S. Department of Energy announced its intent to build long-distance, high-voltage energy transmission facilities, according to its Building a Better Grid Initiative. To help meet emission reduction goals, the Energy Department explained that it would increase transmission lines that transfer energy between renewable energy generation sites. The Energy Department also stated that it would research where transmission lines are most needed and collaborate with federal, state, and tribal entities in making these decisions. To streamline the development of transmission lines, the Energy Department proposed using various financing tools to reduce investor risks because energy projects usually require substantial upfront investments but take long periods to return a profit. Moreover, the Energy Department stated that it will make permitting for transmission lines more efficient so that infrastructure can be built faster.
• The U.S. Department of Agriculture announced a 10-year plan to respond to the wildfire crisis in the United States. The Agriculture Department outlined that it would work with the U.S. Department of the Interior, Tribes, and local stakeholders to identify high risk areas and implement “fuels and forest health treatments” to reduce the risks of fires spreading. The Agriculture Department and other agencies have access to almost $3 billion from the Infrastructure Investment and Jobs Act to carry out this work. Secretary of Agriculture Tom Vilsack stated that working against wildfires “is essential to the future” of both U.S. land and the people who live on it.
• Over 150 former employees of the U.S. Environmental Protection Agency (EPA) sent an open letter to Virginia state senators reportedly asking them to reject the Virginia governor’s nomination of Andrew Wheeler to be Virginia’s Natural Resources Secretary. The former EPA employees reportedly wrote that Wheeler, a former coal lobbyist, treated polluters favorably and “rolled back rules to cut greenhouse gases” during his time as EPA Administrator. Macaulay Porter, press secretary for the governor, responded that Wheeler would protect the environment. Democrats hold a two-vote majority in the Virginia Senate and claim to have the votes to defeat the nomination.
• The Center for Devices and Radiological Health—a branch within the U.S. Food and Drug Administration—issued a strategic plan for its Health of Women Program. The program attempts to “address the steadily growing importance of sex- and gender-specific issues” related to medical devices and their regulation. The center establishes three primary priorities, which includes a roadmap for research on women’s health and medical devices. The center noted in its plan that most biomedical research is based on studies in males, and highlights that female data “are prerequisite” to advancing women’s health in general and medical devices in particular.
• Attorneys general from 46 states requested that an appeals court revive their lawsuit against Meta, which was known as Facebook at the time of the original suit. The coalition argued that the court prematurely denied their earlier complaint that Facebook gained a monopoly over social networking platforms through its purchase of Instagram and WhatsApp. The coalition also argued that the court incorrectly analyzed Facebook’s acquisition of Instagram and WhatsApp as independent events, rather than as parts of a concerted effort to gain a monopoly. New York Attorney General Letitia James cautioned against the social media giant, stating that Facebook has exploited its size to “force small companies out of business and reduce competition.”
• The Consumer Financial Protection Bureau (CFPB) published a bulletin discussing how medical debt collectors and credit bureaus can comply with rules under the new No Surprises Act. The Act—which U.S. Department of Health and Human Services Secretary Xavier Becerra praised as “the most critical consumer protection law since the Affordable Care Act”—established protections from certain types of unanticipated medical bills. CFPB Director Rohit Chopra called the bulletin a “reminder” for debt collectors and credit bureaus “not to collect on or furnish credit reporting information about invalid medical debt.”
• A federal court banned Martin Shkreli—former CEO of Vyera Pharmaceuticals—from participating in the pharmaceutical industry because he suppressed market competition for Daraprim, which is a drug that treats parasitic infections for immunocompromised individuals. The court also ordered Shkreli to pay back $64.6 million that he received in profits from the anticompetitive activity. The court found that Shkreli first began his scheme of monopolizing Daraprim by purchasing the rights to the drug and raising its price substantially. Shkreli also imposed restrictions on Daraprim distribution contracts. This prevented distributors from selling the drug without Vyera’s permission, which limited generic drug companies’ ability to study Daraprim and release a generic and less costly version. Federal Trade Commission chair Lina Khan praised the ruling, stating that it “should be a warning to corporate executives everywhere” who engage in anticompetitive behavior.
• The Federal Motor Carrier Safety Administration announced the details of a pilot program, called the Safe Driver Apprenticeship Pilot, that would allow people between the ages of 18 and 20 to drive commercial trucks between states. A similar pilot program was proposed previously in September 2020, but was never executed. The Infrastructure Investment and Jobs Act, however, required the agency to establish a program that is “substantially the same” as the earlier proposed version. The program is part of a broader trucking action plan aimed at “building a next generation trucking workforce” and addressing other employment issues in the trucking industry.

WHAT WE’RE READING THIS WEEK

• In an article in the Harvard Environmental Law Review, Anthony Moffa, professor at the University of Maine School of Law, discussed how the presence of radon in prisons violates the U.S. Constitution and endangers prisoners, who are disproportionately people of color. Radon, Moffa explained, is dangerous because it is a “odorless and invisible radioactive gas” that can cause cancer. Moffa discussed that the U.S. Supreme Court has already found that the Eighth Amendment’s ban on “cruel and unusual punishments” extends to inhumane prison conditions and argued that exposure to radon in prisons is one such inhumane condition. Moffa concluded that lawsuits brought by prisoners can be challenging to win because it is difficult for plaintiffs to prove that officials had knowledge of harmful substances, and he emphasized that some reformers have suggested removing knowledge requirements altogether.
• In an article in the Yale Journal of Law & Technology, Christopher Morten, professor at Columbia Law School, and Charles Duan, policy fellow at American University, argued that the United States government can use COVID-19 vaccine patents without pharmaceutical companies’ permission to increase supply for under-vaccinated populations. Morten and Duan contended that a provision in patent law allows the federal government to take control of patents that are licensed with the U.S. Patent and Trademark Office. Morten and Duan noted that once the United States takes control of the pharmaceutical companies’ patents, it can release the information needed to make COVID-19 vaccines, allowing manufacturers to increase production of the vaccine.
• In a forthcoming article in the Duke Law Journal, Mason Marks, assistant professor at the University of New Hampshire Franklin Pierce School of Law, examined the use of artificial intelligence and other computer models on FDA regulation. Marks discussed three ways FDA has incorporated technology into the regulatory process, including its use of technology-simulated clinical trials. Marks examined the relationship and impact of such technologies on administrative law, highlighting debate among scholars that indicates “administrative law may be unprepared for automated FDA regulation.” Marks concluded by calling on FDA to modernize its regulatory regime in relation to these new technologies. Marks proposed incorporating principles from artificial intelligence ethics, such as using independent boards to review models, as one way to modernize.

FLASHBACK FRIDAY

• In an essay for The Regulatory Review, Adam M. Finkel, professor at the University of Michigan School of Public Health and former executive director of the Penn Program on Regulation, warned against the dangers of radon gas found in homes across the United States. Finkel estimated that in 2013 there were 8 million U.S. homes where radon levels were “likely to be especially high,” but only one quarter of these homes had ever been tested, despite tests costing less than $40. Finkel noted that because radon caused approximately one-sixth of all U.S. lung cancer cases, federal funds should be used to improve testing and mitigation efforts.