Week in Review

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An FDA committee recommends a COVID-19 vaccine for children, the Supreme Court expedites review of Texas’s abortion law, and more…

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IN THE NEWS

  • An advisory committee for the U.S. Food and Drug Administration (FDA) recommended that FDA issue an emergency use authorization for the Pfizer COVID-19 vaccine for children ages 5 to 11. FDA is not required to follow the advisory committee’s recommendation, but FDA will take the recommendation into consideration when making its final determination in the coming days. In rare cases the Pfizer vaccine may cause heart muscle inflammation. Still, the committee voted in favor of emergency use authorization because “the benefits do outweigh the risk,” according to committee member Amanda Cohn.
  • The U.S. Supreme Court agreed to expedite review of Texas’s restrictive abortion law, which allows private citizens to bring enforcement actions against abortion providers if there is a “steady and repetitive rhythmic contraction of the fetal heart.” The Court will examine whether the United States can sue Texas to prevent the law’s enforcement. The Court will hear in-person arguments from the United States and Texas on November 1, 2021. In a dissenting opinion, Justice Sonia Sotomayor argued that the Court should have halted the law’s enforcement until the Court ruled on its merits. Justice Sotomayor wrote that people “seeking abortion care in Texas are entitled to relief now” and noted that the Court’s continued failure to act means abortion care will come “too late for many” people.
  • The U.S. Department of Health and Human Services (HHS) announced it and other agencies will take actions to increase the availability of over-the-counter COVID-19 tests. HHS noted that the National Institutes of Health and FDA would invest $70 million from the America Rescue Plan to bring these at-home tests to market. The National Institute of Health will also create a program that helps identify and gather data on tests that have “potential for large-scale manufacturing,” for which FDA might grant emergency authorizations. Discussing the partnership between the two agencies, Director of the National Institute of Health Francis S. Collins said the collaboration “will produce the precise data needed to make authorization decisions quickly.”
  • The Federal Trade Commission (FTC) reinstated a “prior approval” rule, which requires a company to receive approval from the FTC before merging with another company. The rule applies to companies that have settled with the FTC in the past. For instance, the FTC could investigate a seemingly anticompetitive company merger in the microchip market and then settle with the companies with a prior approval provision in the settlement. The merging companies, however, would need the FTC’s approval on all future mergers in the microchip market for at least the next 10 years. The FTC may also impose the prior approval rule on companies that have abandoned a merger due to an FTC complaint. Moreover, even if companies are merging within a particular market, the FTC may circumstantially broaden a settlement’s prior approval provision to encompass other types of markets. FTC Director of the Bureau of Competition, Holly Vedova, praised the reinstatement of the rule because it “forces acquisitive firms to think twice before going on a buying binge.”
  • The Biden Administration announced new information related to the policy allowing only vaccinated foreign travelers into the country. The presidential proclamation, effective November 8, 2021, will end all country-specific limitations on travelers and instead impose new vaccine requirements. The Centers for Disease Control and Prevention released accompanying orders, which included directions to implement the vaccine requirement, to collect passenger contact tracing information from airlines, and to update traveler testing requirements. The CDC also provided technical instructions to assist airlines with compliance under the new measures.
  • U.S. Secretary of State Antony Blinken announced a plan to create a new bureau within the U.S. Department of State focused on cyberspace and digital policy. The new bureau will focus on “international cyberspace security, international digital policy, and digital freedom.” A wide range of lawmakers commended the agency on its announcement, including U.S. Representative Michael McCaul (R-Texas) who sponsored the Cyber Diplomacy Act, which the U.S. House of Representatives passed earlier this year.
  • In a letter, the U.S. Department of Education accused the Florida Department of Education of violating the Elementary and Secondary Education Act by withholding funds from two Florida school districts that instituted mask mandates. The Florida Education Department reportedly withheld over $610,000 in federal funding from the two districts for failing to remove their mandates. The U.S. Education Department warned that it is “prepared to initiate enforcement action to stop these impermissible state actions.”
  • FDA announced new measures targeting breast implant safety, so that patients can make informed decisions. Through these measures, FDA seeks to provide patients with more information about the risks related to breast implants, such as the incidence of certain kinds of cancers. The measures include a new requirement for patients to be provided with a “Patient Decision Checklist” prior to surgery and revised labeling requirements for all legally approved breast implants. The new information requirements track existing FDA guidance issued in September 2020. FDA also provided updates on the status of manufacturer studies on breast implants, which are required after FDA approval.

WHAT WE’RE READING THIS WEEK

  • In a report to the U.S. Congress, the U.S. Government Accountability Office (GAO) discussed vulnerabilities of the U.S. electric grid. GAO suggested that U.S. grid vulnerabilities may have resulted from the original grid design, which lacks proper protections because it was not created to be connected to the internet. GAO contended that the U.S. Department of Energy “has not fully addressed risks to grid distribution systems,” because the department’s Multiyear Plan for Energy Sector Cybersecurity fails to address solar inverter or electric vehicle charger vulnerabilities, among other weaknesses. GAO concluded that federal support for energy cybersecurity improvements “will likely not be effectively prioritized” unless the Energy Department better addresses U.S. grid vulnerability.
  • In an article, Catherine M. Sharkey, professor at New York University School of Law, argued that using artificial intelligence (AI) to revise agency rules may compromise transparency and accountability in government. Sharkey contended that HHS, which was the first to incorporate AI into its rule revision process, did not adequately disclose how AI was used in revising its rules. Even if agencies only use AI to correct misspellings or broken citation references, Sharkey argued that AI tools should still receive public scrutiny because they could be used for more substantive rule changes in the future. She concluded that although the public may find AI tools difficult to understand and agencies may find disclosure of AI use burdensome, agencies must still disclose how AI tools are used to preserve democratic ideals.
  • In a report, Aaron Klein, senior fellow at the Brookings Institution, discussed digital money, meaning all forms of money that are not cash or checks, and its possible impact on individual health. Klein argued that lower-income individuals face barriers to accessing digital money and that it is more expensive for them to do so. Klein discussed the relationship between financial health and physical health, such as the health impacts from financial-related stress or the ability to afford health care. Due to the relationship between financial and physical health, Klein suggested that improvements in “financial health should result in physically healthier outcomes.” Klein concluded by offering recommendations for attaining widespread no- or low-cost access to digital money, including imposing requirements on financial institutions to offer free or low-cost accounts, or allowing the Federal Reserve to provide accounts for individuals, among others.

FLASHBACK FRIDAY

  • In an essay in The Regulatory Review, Mark Thomson, deputy director of research at the Administrative Conference of the United States (ACUS), and John F. Cooney, senior fellow at ACUS, discussed consequences of federal agencies increasingly using artificial intelligence for governance tasks such as adjudication, data collection and analysis, and communications. Thomson and Cooney explained that even though artificial intelligence can increase accuracy and efficiency, this technology can also be vulnerable to issues of privacy and a lack of oversight or accountability. To combat these issues, ACUS published guidance for agencies to consider when implementing artificial intelligence, but Thomson and Cooney argue that ultimately agencies will have to make their own decisions about artificial intelligence policy on an “agency-by-agency basis.”