Week in Review

IN THE NEWS

• The U.S. Supreme Court allowed New York to enforce a firearm law—passed in response to the Court’s decision in Bruen—that adds requirements for obtaining gun licenses and restricts carrying guns in more public places. The Court let the law remain in effect pending an appeal of a federal district court decision blocking the law. Justices Samuel Alito and Clarence Thomas commented that the law “presents novel and serious questions under both the First and Second Amendments,” but emphasized that a federal appellate court should address those issues first.
• The U.S. Food and Drug Administration (FDA) granted accelerated approval of the drug Leqembi to treat Alzheimer’s disease. The accelerated approval process allows FDA to approve conditionally drugs that address unmet needs and have been proven likely to benefit patients. Leqembi removes amyloid, a plaque-like substance whose presence in the brain is indicative of Alzheimer’s. A study found that use of Leqembi for 18 months led to a 27 percent reduction in the decline of patients’ cognitive ability. Maria Carrillo, chief science officer for the Alzheimer’s Association, called the approval a “milestone” for patients and their families, but Joy Snider, a professor at Washington University School of Medicine in St. Louis, cautioned that the drug is “not a cure.”
• The Centers for Medicare and Medicaid Services (CMS) announced its plan to implement a Medicare drug pricing negotiation program, which will set maximum fair price ceilings, as authorized by the Inflation Reduction Act. CMS intends to begin negotiating drug prices in 2023 and implement the new prices in 2026. The agency encouraged public feedback during the negotiating process. U.S. Department of Health and Human Services Secretary Xavier Becerra praised the action, stating that the agency will be “transparent and aggressive in implementation every step of the way.”
• The U.S. Department of Education proposed regulations to lower the cost of federal student loan payments for certain borrowers. The Education Department recommended these reductions to income-driven repayment plans, which tie monthly payment amounts to the borrower’s income level for a set number of years, after which any remaining debt is forgiven. The proposal increases the number of borrowers who will not be required to make any monthly payment and reduces the payment required from borrowers who do not meet this threshold by half. Education Department Secretary Miguel Cardona stated that the proposed regulations will allow borrowers to “focus on building brighter futures for themselves and their families.”
• The Federal Prisons Bureau proposed a rule that would update the inmate financial responsibility program, which encourages inmates to pay financial obligations including court ordered restitution, court fees, and child support while imprisoned. Although the program is voluntary, refusal to participate can result in consequences such as spending restrictions and loss of early release. The proposed rule includes updates such as adopting court-ordered payment plans as an inmate’s financial plan and removing an outdated policy that reserved $75 of the inmate’s funds a month for familial calls, which prisons now ensure are available to inmates without withholding funds from financial planning.
• FDA issued guidance on requirements for foreign food supplier verification programs governing the import of food into the United States. The guidance suggests that food importers should establish a list of approved suppliers by looking at history of FDA compliance and later verify foreign suppliers by auditing and sampling their food before importing it. According to FDA, these suggested guidelines are designed to ensure that any imported food meets federal regulations prohibiting adulteration and requiring accurate allergen labeling.
• The Federal Aviation Administration (FAA) ordered airlines to pause all flights for two hours due to a system outage. The FAA’s system alerts airports and pilots of hazards and changes in the national airspace. The pause caused over 1,000 flight cancellations and thousands of delays. U.S. Department of Transportation Secretary Pete Buttigieg said that a damaged database file caused the outage. Secretary Buttigieg also stated that there was “no evidence of a cyber attack” and that the agency will work to prevent future outages.
• The Department of Homeland Security released notice of a new parole process for Nicaraguan nationals seeking to enter the United States. The new process would provide some eligible Nicaraguan nationals advanced authorization to enter the United States before they undergo an evaluation for parole or temporary admission into the country. Eligibility criteria includes whether they have someone living in the United States who will meet certain national security considerations and provide financial support to them during the evaluation process. The Department designed this process to increase security at the country’s southwest border by allowing Nicaraguans a safer, more orderly passage of travel into the United States.

WHAT WE’RE READING THIS WEEK

• In an article in the Journal of the American Medical Association, Aaron S. Kesselheim, Jerry Avorn, and Ameet Sarpatwari, all professors at Harvard Medical School, argued that the United States’ high drug prices result primarily from FDA granting monopoly rights to manufacturers and posed several reforms. Kesselheim, Acorn, and Sarpatwari claimed that the United States’ drug prices are higher than other industrialized countries because drug manufacturers are able to designate drug prices for their own products. Kesselheim, Avorn, and Sarpatwari also pointed to patent exclusivity and automatic periods of at least 5 years before generics—the main marketplace competition for name-brand drugs—can be produced as causes for high drug prices. Kesselheim, Avorn, and Sarpatwari suggested that the most effective, yet idealistic, reform to the industry would be for the federal government to set drug prices for the marketplace.
• In an article in the Environmental Law Review, Rachael E. Salcido, professor at Pacific McGeorge School of Law, argued that the Clean Water Act provides regulatory tools for the federal government to address plastic pollution. The Act, Salcido explained, authorizes the government to set water quality standards, bolster existing water quality protections for plastic production, and increase pressure on states to strengthen plastic production oversight. Salcido noted that private citizens and environmental groups have filed lawsuits that highlight the remedial actions the government should take under the Act.
• In a forthcoming article in the Emory Law Journal, David A. Simon, Research Fellow at Harvard Law School’s Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, argued that FDA should end its restrictions on drug manufacturers’ speech about unapproved uses for a drug. The current system, Simon explained, bars all speech discussing off-label uses absent two narrow exceptions. Simon proposed instead a sliding scale system where speech that is well-supported by evidence is subject to few restrictions, while less-supported statements receive more scrutiny. Simon contended that this evidence-based approach allows for a more effective regulatory framework than the current, less flexible model.

EDITOR’S CHOICE

• In an essay in The Regulatory Review, Luke Herrine, now a professor at the University of Alabama School of Law, argued that the Education Department had historically taken a minimalist approach to student debt forgiveness because some officials viewed student loans as a source of government revenue. Herrine explained that this thinking underlied the Education Department’s reluctance to forgive the debt of students defrauded by for-profit colleges even after Congress had provided the Education Department with this authority. Herrine contended that the Education Department needed to begin viewing student loans as a burden on individual borrowers, rather than as a potential revenue source.