FDA approves emergency use of the nation’s second COVID-19 vaccine, Congress passes government spending bill, and more…
IN THE NEWS
- The U.S. Food and Drug Administration (FDA) issued an emergency use authorization for the nation’s second COVID-19 vaccine developed by biotechnology company Moderna. Results of clinical trials showed that the vaccine was over 94 percent effective in preventing the disease, meeting the agency’s criteria for emergency use approval. To date, the U.S. government has ordered 200 million doses of the Moderna vaccine and retained an option to buy a maximum of 300 million additional doses. Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, emphasized the high degree of scrutiny that the agency applied in analyzing the data on the vaccine’s results, affirming that FDA maintained “scientific standards and the integrity of our review process.”
- The U.S. Congress passed a $2.3 trillion year-end government spending bill, including a $900 billion pandemic relief package. The bill passed the U.S. House of Representatives and the U.S. Senate by overwhelming margins after months of negotiation. The bill includes another round of small-business aid through the Paycheck Protection Program, a $300 per week supplemental unemployment benefit, and a $600 direct stimulus payment to Americans making under $75,000 annually. Senate Minority Leader Chuck Schumer (D-N.Y.) called the bill a start but added that “anyone who thinks this bill is enough has not heard the desperation in the voices of Americans.”
- The U.S. Department of Labor finalized a rule that changes tip pooling and minimum wage practices in the hospitality industry. According to the Labor Department, the rule could result in a $109 million transfer from workers to employers in the first year. The rule formalizes prior guidance that allows employers to pay workers who receive at least $30 per month in tips a wage of $2.13 per hour for tasks that do not lead to tips, such as pre- or post-shift work. The rule also clarifies that any business that pays tipped workers the standard minimum wage may establish a tip pool that includes cooks and dishwashers, who are usually not permitted to share tips under the Fair Labor Standard Act. House Committee on Education and Labor Chair Robert Scott (D-Va.) criticized the rule for stripping tipped workers of essential protections, saying that “dishonest employers will be able to ‘save’ money by exploiting tipped workers.”
- The U.S. Department of Justice sued Walmart for allegedly contributing to the opioid crisis by violating controlled substances dispensing rules and Walmart’s duty to detect and report suspicious orders of controlled substances. The Justice Department alleged that Walmart managers pressured pharmacists to fill prescriptions as quickly as possible, resulting in hundreds of thousands of violations of the Controlled Substances Act. If the court finds Walmart liable for violating the act, Walmart could face civil penalties over $67,000 for each unlawful prescription pharmacists filled and $15,000 for each suspicious order the company failed to report. Acting Assistant Attorney General Jeffrey Bossert Clark said that “Walmart had the responsibility and the means to help prevent the diversion of prescription opioids,” and instead “did the opposite.”
- New York Governor Andrew Cuomo signed into law a bill that requires state agencies to establish an automatic voter registration system. Designated agencies must provide voter registration information to the state board of elections on individuals who apply to use the agency’s services, meet voter eligibility requirements, and give permission to be registered. New York State Senator Michael Gianaris stated that access “to the ballot box should be easy and fair, and enacting automatic voter registration will go a long way toward improving voter participation.”
- Congress approved the creation of two new Smithsonian museums dedicated to Latinos and women. The Smithsonian Institution needs federal legislative approval to establish a new museum. Earlier this month, Senator Mike Lee (R-Utah) blocked legislation that would lead to the creation of an American Latinos museum and a women’s museum, reportedly saying that “the last thing we need is to further divide an already divided nation with an array of segregated, separate-but-equal museums.” Senator Bob Menendez (D-N.J.) called the congressional authorization a victory and added that the Latino community has “overcome tremendous obstacles and unbelievable hurdles to get to this historic moment.”
- The U.S. Environmental Protection Agency (EPA) finalized revisions to a regulation addressing lead in drinking water. The final rule will require EPA to notify consumers within 24 hours when there is a “system-wide” incidence of high lead levels and within three days when individual tap samples exceed a set limit. The final rule will also require community water systems to test water samples in schools and child care centers for lead for the first time. Betsy Southerland, a former director at EPA’s Office of Water, reportedly criticized EPA for issuing a “do nothing rule” that fails to “take action on the more substantive thing of replacing more lead service lines.”
- President Donald J. Trump issued an executive order that makes classical architecture derived from Greek and Roman antiquity the default architectural style of federal buildings. The executive order targeted a program put in place by the U.S. General Services Administration in 1994 known as the Design Excellence Program, which commissions established architects to design federal civic buildings in a contemporary style that diverges from the classical forms of iconic buildings in Washington, D.C., such as the White House and the U.S. Capitol Building. President Trump denounced the architecture under the program, claiming that it “impresses the architectural elite, but not the American people who the buildings are meant to serve.” The American Institute of Architects responded with a statement affirming its commitment to work with the incoming Biden Administration to reverse the order.
- The U.S. Air Force Inspector General published an independent report assessing racial disparities in the U.S. Air Force. The Air Force Inspector General found racial disparities in the treatment of Black service members in disciplinary action, job placement, promotion rates, and leadership opportunities. For instance, Black service members were 72 percent more likely than white service members to receive non-judicial punishment. Because the report does not address the reasons for racial disparities, the Inspector General recommends deeper analysis to uncover the cause of these disparities and recommendations to address them. In response to the findings, General John W. Raymond, chief of space operations for the U.S. Space Force, called for change, stating that “accountability begins with us, and we have the opportunity to create a culture that inherently values diversity and inclusion.”
WHAT WE’RE READING THIS WEEK
- In a forthcoming article for the Lewis and Clark Law Review, Daniel Aaron, an attorney at the Office of the Chief Counsel of the U.S. Food and Drug Administration (FDA), analyzed the challenges that FDA faced in controlling the explosive growth of e-cigarette use among youth in the United States. Aaron argued that the control that the President can exercise over FDA has had a negative effect on the agency’s ability to regulate e-cigarettes and enabled the tobacco industry to have an outsized influence on FDA’s policymaking. In addition to several other proposed solutions, Aaron advocated that the U.S. Congress should grant FDA automatic jurisdiction to regulate any product that causes addiction or dependency.
- The Office of the Inspector General for the U.S. Department of Health and Human Services found in a new report that the Indian Health Service, an agency that oversees medical services for federally recognized Native American tribes, has made strides to implement policies that protect patients from sexual misconduct by agency staff. The push to implement these policies followed the conviction of Stanley Patrick Weber, a former pediatrician who was found guilty of sexually abusing young Native American boys for over two decades. In its report, the Office of the Inspector General emphasized that the agency should still ensure that it has an adequate reporting system in place that protects the anonymity of patients and staff who wish to report suspected abuses.
- In an article for the Yale Journal on Regulation, Charles Silver and David Hyman argue that consumers pay twice for medications—once when taxpayer money funds research, and again when pharmaceutical companies charge monopoly prices on patented drugs. The authors explore the challenges of allocating credit and profit when multiple parties contribute meaningfully to a complex process and examine the construction of a convention center in Austin, Texas as a case study. They suggest that a prize system would be better than the patent system at encouraging innovation while reducing drug prices.
- In a lecture hosted by The Regulatory Review, President-Elect Joe Biden’s nominee for national climate adviser, Gina McCarthy, encouraged attendees to continue forging a path toward a safer, more prosperous future. McCarthy promoted public engagement and state regulation as effective tools when the federal government fails to make responsible rules to protect people and the environment against climate change. McCarthy explained that both Democrats and Republicans have been good allies in environmental protection throughout her career and shared her hope that policymakers can overcome modern political division over climate change and clean energy.