Week in Review

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President Biden signs an executive order to strengthen antitrust enforcement, FDA commissioner requests a federal investigation of a new Alzheimer’s drug, and more…

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IN THE NEWS

  • President Joseph R. Biden signed an executive order to fight concentration across industries in the American economy by strengthening the enforcement of antitrust laws. The Biden Administration claimed that consolidation and concentration within markets have reduced competition and increased inequality. To address these dynamics, the Administration directed federal agencies, including the U.S. Department of Justice and the Federal Trade Commission, to challenge mergers that went unchallenged by prior administrations and focus their efforts on labor, agricultural, health care, and technology markets. The Administration argued that its order will raise wages, lower prescription drug prices, and save consumers money on internet bills, among other benefits.
  • Acting U.S. Food and Drug Administration (FDA) Commissioner, Janet Woodcock, requested an internal investigation of the process that led to FDA’s approval of Aduhelm, a drug created to treat Alzheimer’s disease. Woodcock’s request came after three FDA advisory panel members resigned after Aduhelm was approved and an FDA committee questioned the drug’s efficacy. Woodcock’s letter called on the U.S. Department of Health and Human Services Office of Inspector General to review the interactions between the drug’s developer and FDA for compliance with FDA policies. Woodcock explained that FDA believed an independent investigation would best ensure transparency and public trust.
  • U.S. Immigration and Customs Enforcement (ICE) issued a directive that it will no longer “detain, arrest, or take into custody for an administrative violation” individuals who are known to be pregnant, nursing, or who have given birth within one year, unless, for instance, an individual poses a threat to national security or otherwise creates an extraordinary circumstance. When detention is necessary, the policy mandates that ICE monitor the health and well-being of individuals in custody, including by providing natal and mental health care. Under the policy, ICE can still begin removal proceedings against individuals—including those known to be pregnant, nursing, or postpartum—and enforce all applicable U.S. Department of Homeland Security and ICE immigration policies.
  • In a joint statement, the U.S. Centers for Disease Prevention and Control (CDC) and FDA stated that fully vaccinated Americans do not need a booster shot at this time to protect themselves against COVID-19 variants. The agencies stated, however, that they will continue to monitor new data and are prepared to recommend additional shots if there is evidence that booster shots are needed. The CDC and FDA statement was released the same day that Pfizer and BioNTech issued a press release indicating that they believed a third dose could be beneficial in boosting antibody levels. Pfizer’s chief scientific officer Mikael Dolsten reportedly said that the company would submit data supporting potential benefits to FDA within the next month.
  • The European Commission released Fit for 55, a set of proposals aimed at reducing carbon dioxide “emissions by at least 55% by 2030 compared to 1990 levels.” The proposals included a new tariff system for imports from countries with more relaxed emissions rules than those of the European Union. The proposal package also called for all new cars to be zero-emission vehicles by 2035 and proposed adjustments to the European Union’s emissions trading scheme to reduce emissions. Commission President Ursula von der Leyen reportedly said that “it is our generational task” to secure “the well-being of not only our generation, but of our children and grandchildren” and that “Europe is ready to lead the way.”
  • The CDC issued new guidelines to encourage K-12 schools to reopen fully for in-person instruction and extracurricular activities in the fall. The CDC guidelines recommend that schools maintain at least three feet between students indoors. If schools are unable to maintain this distance between students, the CDC recommends that schools implement other safeguards such as indoor mask wearing. The CDC guidelines also permit vaccinated students to go maskless indoors, and they promote vaccination as the leading preventative measure to end the COVID-19 pandemic. Randi Weingarten, president of the American Federation of Teachers, praised the guidance as “grounded in both science and common sense.”
  • The U.S. Department of Education authorized 100 percent federal loan forgiveness for students who filed claims against Westwood College, Marinello Schools of Beauty, or the Court Reporting Institute, totaling about $56 million in relief. The Education Department grounded its decision in findings that the institutions made widespread, substantial misrepresentations to students about student preparedness for licensure exams upon graduation or program completion, among other things. Secretary of Education Miguel Cardona said that the Department hopes the approvals “serve as a warning to any institution engaging in similar conduct that this type of misrepresentation is unacceptable.”
  • The U.S. Environmental Protection Agency (EPA) announced a new draft list of contaminants found in drinking water that are not regulated by the agency. The list includes a group of chemicals known as per- and polyfluoroalkyl substances (PFAS), which the agency has committed “to better understand and ultimately reduce the potential risks” the chemicals cause. EPA has said evidence shows “exposure to PFAS can lead to adverse health outcomes in humans.” Environmental groups have pushed for EPA to regulate PFAS as an entire group because a “chemical-by-chemical approach” would take too long, reportedly noted David Andrews, a senior scientist with the Environmental Working Group.

WHAT WE’RE READING THIS WEEK

  • In an article in the Journal of the American Medical Association Pediatrics, Larissa Morgan, former editor-in-chief of The Regulatory Review, Jason L. Schwartz, associate professor at the Yale School of Public Health, and Dominic A. Sisti, director of the Scattergood Program for Applied Ethics in Behavioral Health Care, argued that minors over 14 years old can make informed decisions related to their health and that states should pass laws to empower minors to consent to COVID-19 vaccination without parental approval. To balance developmental needs, parental interests, and minors’ individual autonomy, Morgan, Schwartz, and Sisti recommended that healthy children under 12 years old should receive parental approval before being vaccinated; children ages 12 to 14 could consent if supported by a clinician or other trusted adult; and children ages 15 to 17 could provide consent without parental knowledge. Morgan, Schwartz, and Sisti concluded that states should not only expedite minor consent authorization of the COVID-19 vaccine during the current pandemic, but that states should also implement these permissions for all vaccinations in the long term.
  • In a forthcoming paper to appear in the Florida State University Law Review, Margaret Kwoka, professor at the Sturm College of Law, and Bridget DuPey, attorney at Brownstein Hyatt Farber Schreck argued that accountability in government can be achieved in part through “targeted” transparency. Kwoka and DuPey coined the phrase “targeted transparency as regulation” to describe governmental transparency requirements which would mirror the requirements that companies disclose data including financial records and safety hazards. Kwoka and DuPey argued that private disclosure requirements are aimed at producing consequences, which transparency measures in the government could mimic. Kwoka and DuPey concluded that targeted transparency could provide a framework of disclosure guidelines on which to base future government accountability laws.
  • In a recent article, Natasha Sarin, professor at the University of Pennsylvania Law School and Deputy Assistant Secretary at the U.S. Treasury Department, Cary Coglianese, professor at the University of Pennsylvania Law School, and Stuart Shapiro, professor at the Edward J.Bloustein School of Planning and Public Policy at Rutgers University, put forward data showing that the Trump Administration accomplished less deregulation than it claimed and that many commentators have thought. Sarin, Coglianese, and Shapiro further argued that, despite the Trump Administration’s claims that deregulation helped the economy, the Administration’s deregulatory efforts merely coincided with a continuation of existing economic trends, rather than causing any substantial changes. Sarin, Coglianese, and Shapiro suggested that regulatory policy changes are more difficult to accomplish than they seem, but that even without significant regulatory changes, political leaders may still be able to make their efforts seem substantial to the public.

FLASHBACK FRIDAY

  • In an essay in The Regulatory Review, Todd Phillips, now an attorney with the Federal Deposit Insurance Corporation, argued that the Federal Trade Commission (FTC) should use adjudication to regulate non-compete agreements in employment contracts. Phillips suggested that to address the proliferation of such agreement policymaking by adjudication, rather than rulemaking, would avoid delays and legal requirements that are imposed only on rulemaking. Phillips concluded that, although policymaking by adjudication is not ideal in every case, adjudication can send a clear message to employers while allowing the FTC to maintain its independence and flexibility when regulating non-compete agreements.