Scott Gottlieb announces resignation from FDA, Democrats propose new bill to restore Obama-era Internet regulations, and more…
IN THE NEWS
- Dr. Scott Gottlieb announced his resignation as Commissioner of the U.S. Food and Drug Administration (FDA), which will take effect in one month. As FDA Commissioner, Gottlieb pushed for stricter regulation of e-cigarettes and tobacco products to combat their use by teenagers. The U.S. Department of Health and Human Services (HHS) Secretary Alex M. Azar said that the “public health of our country is better off” due to the accomplishments of Gottlieb and FDA during the past two years. But Dr. Michael Carome of Public Citizen stated that Gottlieb’s tenure “was marked by regulatory decision making regarding medications and medical devices that tilted further in favor of industry’s financial interests rather than the interests of public health.”
- Democrats in both the U.S. House of Representatives and Senate unveiled a new bill that would reverse the Federal Communications Commission’s (FCC) vote to repeal its net neutrality rules and would revive the Obama-era Open Internet Order. In response, a spokesperson for FCC Chairman Ajit Pai said that “the Internet in America today is free and vibrant, and the main thing it needs to be saved from is heavy-handed regulation from the 1930s.” FCC Commissioner Geoffrey Starks, however, applauded the legislation and hoped that its introduction would “lead to restoration of the common-sense protections needed to keep the Internet open.”
- HHS issued a final rule revising the regulations governing Title X’s family planning program. The final rule would prohibit the use of any “funds appropriated for Title X” in programs where “abortion is a method of family planning.” The rule becomes effective on May 3, 2019 and compliance is required by March 4, 2020.
- The U.S. Environmental Protection Agency (EPA) announced a settlement with ExxonMobil that would resolve ExxonMobil’s alleged violations of accident prevention provisions of the Clean Air Act during a 2013 fire at the company’s Beaumont, Texas oil refinery. The settlement will require ExxonMobil to pay a civil penalty of $616,000, hire an independent compliance auditor, and purchase a specialized vehicle for the Beaumont Fire and Rescue Service to improve its ability to respond to any future “hazardous-material incident.”
- President Donald J. Trump nominated Jessie K. Liu to serve as Associate Attorney General, the third-ranking position at the U.S. Department of Justice—a post that has remained unfilled for more than a year. Liu currently serves as the U.S. Attorney for the District of Columbia. If confirmed by the U.S. Senate, Liu will manage civil litigation matters at the Justice Department including antitrust and civil rights violations.
- The U.S. Department of Agriculture (USDA) and FDA announced a formal agreement to jointly regulate “cell-cultured food products”—meat that is grown in a laboratory from animal cells. The agencies agreed that FDA would oversee the cultivation and growth of animal cells, but USDA’s Food Safety and Inspection Service would oversee the “production and labeling of human food products” developed from the cultivated cells.
- The FCC issued a proposed rule that would implement recently adopted amendments clarifying the Truth in Caller ID Act’s “prohibition on the use of misleading and inaccurate caller ID information.” The proposed rule would expand the regulations beyond telecommunications services to include Internet calling and text messaging services, and it would extend enforcement to calls originating outside of the United States. Comments will be accepted until April 3, 2019.
- FDA approved a new medication for patients with treatment-resistant depression—defined as major depressive disorder that does not respond to at least two traditional antidepressant courses of treatment. The approved medication is a nasal spray that must be administered in a clinical setting due to the risk of sedation and abuse that could result if patients took it at home. The spray received FDA’s Fast Track and Breakthrough Therapy designations, which helped to streamline its approval process.
- The Utah House of Representatives passed a bill repealing the criminal offense of fornication, which classified “voluntary” sexual intercourse of “any unmarried person” as a misdemeanor. State representative Kevin J. Stratton (R) reportedly objected to the bill, stating that legal behavior can still be “far below what is morally right.” The Utah Senate had previously passed the bill, which now awaits a signature or veto from Governor Gary R. Herbert (R).
WHAT WE’RE READING THIS WEEK
- Regulations that are “business-friendly” are linked to lower national poverty levels, according to a recent paper by Simeon Djankov, Dorina Georgieva, and Rita Ramalho of The World Bank. Djankov, Georgieva, and Ramalho found that pro-business regulations governing credit and contract enforcement were particularly correlated with a decreased poverty headcount. The authors argued that “business-friendly” regulations encourage the formation of new businesses, which in turn “generate jobs and opportunities for the poor” and result in lower poverty levels.
- In a forthcoming article in the University of Richmond Law Review, University of Missouri School of Law professor Erika Lietzan examined FDA’s “new drug authorities,” finding that they ensure disclosure and give federal regulators a “leash” on new drugs. Lietzan argued that, although some features may need changing, the new drug approval “paradigm” is worthwhile.
- In a recent paper, Thomas B. Nachbar, professor at the University of Virginia School of Law, analyzed restrictions on state regulation of net neutrality in light of the U.S. Supreme Court’s liberation of the Dormant Commerce Clause. Nachbar noted that the “economic theory” fundamental to net neutrality regulation makes it “especially problematic” under the Dormant Commerce Clause and concluded that net neutrality regulation is “poorly suited for state regulation.”