Food and Drug Law
Black box warnings are assigned to prescription drugs by the U.S. Food and Drug Administration (FDA) to alert of serious sides effects, such as injury or death. The smoking cessation drug, Chantix, previously had one of these black box warnings attached to it, but that warning has since been removed. This transition from a “dangerous drug” to a non-dangerous drug raises various important regulatory concerns regarding the marketing of this drug and other popular prescription drugs as well as the role of the FDA in regulating “dangerous” drugs.
After five years, the Food and Drug Administration (FDA) has approved a drug for ALS (amyotrophic lateral sclerosis): Relyvrio. While the drug is expected to significantly prolong the life of ALS patients, who typically die within a few years after diagnosis, the fast approval of the drug raises concerns regarding the FDA’s fast-tracking process of approval.
During the COVID-19 pandemic, the federal government and the Drug Enforcement Agency (DEA) temporarily lifted the Ryan Haight Act’s mandate that imposes federal prohibition on online prescribing of controlled substances. The DEA waived its in-person medical examination requirement and set forth different criteria for controlled substances. For as long as the duration of the public health emergency (which was extended through January of 2023 this month), a patient can receive a controlled substance prescription without an in-person examination if the communication was conducted in a two-way, audio-visual, and real-time interactive communication. Covid highlighted the increased use of telehealth and digital health platforms. However, as telehealth surged, public policy has failed to move at the same speed.
On October 11, 2022, the Supreme Court began to hear the case of National Pork Producers Council v. Ross. The issue of this case stems from Proposition 12, a 2018 ballot revision to existing California law that banned the sale of “whole pork meat from animals confined in a manner inconsistent with California standards.” The National Pork Producers Council and the American Farm Bureau Federation (both referred to as “the Council”) argue that Proposition 12 violates the Dormant Commerce Clause and has reached the Supreme Court on this issue.
The plant-based food market has been exploding in recent years, with the plant-based meat market expected to reach a value of $7.4 billion by the end of 2022 and the alternative dairy market reaching a value of $23.2 billion in 2021.
The meat and dairy alternative markets require regulation, but despite their widespread and growing popularity, the U.S. Food and Drug Administration (FDA) has been slow to issue regulations that encompass these markets. In January 2022, the FDA released a list of draft and final guidance topics that it intends to complete before the end of 2022. These topics include draft guidance for plant-based dairy alternatives, plant-based meat alternatives, and for cultured meat. The FDA is soliciting public comments on the proposed guidance, although as of now none of the draft guidance topics have been released to the public
Thanks to a new FDA final rule, published in August of this year, Americans can soon purchase specific hearing aids over-the-counter (OTC) without a hearing exam, prescription, or fitting. Although this rule will improve access to hearing aid devices and lower the costs for those with hearing impairments, many critics are convinced the rule will do more harm than good.