Week in Review

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FDA approves emergency use of the first COVID-19 vaccine, the Labor Department finalizes its fiduciary rule, and more…

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IN THE NEWS

  • The U.S. Food and Drug Administration (FDA) issued an emergency use authorization for the first COVID-19 vaccine. Frontline workers have already started receiving the Pfizer-manufactured vaccine, as U.S. hospitals and nursing homes continue vaccine distribution preparation for patients. Meanwhile, the Trump Administration is negotiating with Pfizer on plans to manufacture more vaccines for millions of Americans in early 2021, while FDA scientists evaluate a second COVID-19 vaccine for emergency use approval. FDA Commissioner Stephen Hahn praised the agency’s approval of the Pfizer vaccine as a “significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world.”
  • The U.S. Department of Labor completed its fiduciary rule, which governs the conduct of advisers and brokers when advising clients about their retirement accounts. The new rule provides exemptions for advisors who give time-limited advice about Rollover IRAs, among other things. Under the rule, isolated advice about IRAs will not trigger fiduciary duties, meaning that advisers will not be bound under federal law to act in the best interest of their clients when advising them. Barbara Roper, director of investor protection at the Consumer Federation of America, reportedly stated that she does not expect the rule, which is slated to take effect after the Biden transition, “to survive in its current form.”
  • The European Commission released draft legislation to strengthen regulators’ ability to control big tech. If adopted, the Digital Services Act would require large social media companies and e-commerce websites to clear harmful and illegal content from their platforms. Meanwhile, the Digital Markets Act would bolster antitrust efforts by prohibiting big tech firms from taking certain anti-competitive actions, such as using business users’ data to compete with them. European Union Commissioner Margrethe Vestager said that the proposals will ensure that “we, as users, have access to a wide choice of safe products and services online, and that businesses operating in Europe can freely and fairly compete online just as they do offline the proposals.”
  • A joint rule from the U.S. Department of Homeland Security and U.S. Department of Justice amends existing regulations for credible fear determinations in the asylum-seeking process. Under the credible fear standard, migrants seeking asylum based on fears of persecution or torture in their country of nationality must demonstrate their fear to the satisfaction of an asylum officer to avoid removal from the United States. Under the new rule, such migrants no longer have a right to a full immigration court proceeding. In addition, migrants undergoing credible fear screenings must now show a “reasonable possibility” that they will be persecuted due to race, religion, nationality, membership in a particular social group, or political opinion.
  • The U.S. Department of Agriculture issued a long-anticipated final rule that clarifies the scope of producer conduct that is prohibited under the Food, Conservation, and Energy Act, a law that protects fair and competitive markets and financial integrity in the livestock, meat, and poultry industry. The final rule outlines prohibited conditions that would create unfair market advantages for producers. The Secretary of Agriculture would consider whether there exist price differences that indicate preferential treatment toward certain industry stakeholders that are not justified by a “reasonable business decision,” cost savings, or competitors’ prices and market terms. The National Pork Producers Council reportedly praised the rule, noting that it clarifies over a decade of regulatory uncertainty on marketplace competition for farmers. National Farmers Union President Rob Larew, however, reportedly expressed concern that the rule favors meatpackers at the expense of farmers and advocated the rule’s reversal.
  • As part of its continued deregulatory agenda, the U.S. Department of Health and Human Services (HHS) announced proposed changes to the Health Insurance Portability and Accountability Act, a privacy law that protects patient health information. The proposed rule would expand patients’ access to their health data by increasing rights to inspect health records, reducing certain identity verification processes, and permitting patients to direct the exchange of data between their providers. Some health law experts note that the rule would offer more flexibility to providers and patients, but they express concern that relaxing security protocols such as identity verification might increase opportunities for fraud.
  • President-Elect Joe Biden selected former South Bend, Indiana mayor and 2020 presidential candidate Pete Buttigieg as his nominee for secretary of the U.S. Department of Transportation (DOT). As a supporter of Obama-era vehicle emissions regulations and carbon neutrality pledges, Buttigeg’s policy priorities reflect the incoming Administration’s focus on advancing infrastructure while addressing climate change. Buttigieg’s nomination also has historic significance, as he would be the first openly gay cabinet secretary if the U.S. Senate confirms his nomination.
  • The U.S. Supreme Court ruled in favor of religious groups in Colorado and New Jersey seeking exemptions from their states’ health orders that limit capacity at services amid the coronavirus pandemic. In a 6-3 vote in the Colorado case, the Court ordered a lower court to reconsider its denial of a church’s request for temporary relief to prevent the state from enforcing capacity limits at services. The Court ruled similarly in the New Jersey case, which challenged state rules limiting attendance at houses of worship to the lesser of 150 people or 25 percent of the building’s capacity and permitting only brief removal of masks in those buildings. In the Colorado case, Justice Elena Kagan dissented since Colorado had already lifted the challenged orders, making the case moot.
  • The Supreme Court will hear a case on whether National Collegiate Athletic Association (NCAA) rules about student-athlete compensation violate antitrust law. The NCAA appealed from a lower court ruling that invalidated the athletic association’s restrictions on offering certain education-related benefits, such as computers and graduate school tuition, as student-athlete compensation. In its appeal, the NCAA said that “the question here is whether sports organizations and other joint ventures will have the ability to define the character of their own products.” Meanwhile, the students who won in the lower court argue that limitations on student compensation “represent a classic horizontal restraint of trade—an agreement among competitors to limit how much they will have to expend to compete for talent and labor.”
  • A new rule from the DOT narrows the definition of “service animal” under the Air Carrier Access Act. Under the new rule, only dogs “individually trained to do work or perform tasks for the benefit of a qualified individual with a disability” count as a service animal for disability accommodations in air travel. The new rule also excludes emotional support animals from protections. Airlines for America expressed support for the new rule, stating that the “misbehavior of some” emotional support animals “threatens the health and safety of passengers and crew.” Prairie Conlon, a clinical manager for an animal-assisted therapy organization, reportedly called the rule “textbook discrimination” against people with mental health disabilities who use emotional support animals.

WHAT WE’RE READING THIS WEEK

  • In an analysis for Health Affairs, Rebecca Weintraub of Harvard Medical School and her coauthors reviewed past successes and failures in vaccine delivery during past pandemics. Weintraub and her coauthors urged the use of evidence-based vaccine delivery strategies to generate vaccine demand, allocate and deliver doses, and confirm coverage. According to Weintraub and her authors, confirming vaccine coverage presents a formidable challenge in the United States because of state and federal privacy law and difficulties coordinating information exchanges between states. In response to this challenge, the authors recommended vaccine mandates at the employer level, which would assure vaccination for a significant portion of the population.
  • In a report for the Brookings Institution, two University of Virginia professors, Rachel Augustine Potter and Craig Volden, discussed how the Biden Administration can increase women’s representation and leadership in the rulemaking process. According to Potter and Volden’s research, a presidential administration can increase its success in regulation by strategically placing leaders in certain agency positions. Notably, they found that women more effectively lead rulemaking processes at agencies that support women and foster a collaborative culture. Based on these results, Potter and Volden encouraged the Biden Administration to implement strategies that improve support for women in agencies.
  • In a new report, Center for American Progress founder John Podesta, deputy director for climate and energy policy Bidisha Bhattacharyya, and research associate Bianca Majumder recommended policies for the Biden Administration to address the global climate crisis. Podesta, Bhattacharyya, and Majumder urged President-Elect Joe Biden, upon his first days in office, to issue an executive order restoring science-based decision-making in federal policymaking and a memo reforming the social cost of carbon. They also provided steps for the Biden Administration to take in its first 100 days, including restoring protections under the Endangered Species Act, collaborating with international partners, and building a team of diverse, talented federal climate science experts, among other recommendations.

FLASHBACK FRIDAY

  • In an essay in The Regulatory Review, Philip E. Rubin of Yale University School of Medicine examined how cutting-edge research, including neuro-technology and gene editing, creates new regulatory challenges. Rubin described the history of human subjects research regulation, noting that ethical standards such as informed consent from study participants has become a central feature to modern research regulation. Although modern regulations account for ethical issues in research on humans, Rubin advised federal officials to form an interagency group on research ethics to discuss emerging technologies’ unique ethical challenges.