Martha Leon Fernandez
The U.S. Food and Drug Administration (FDA) and the U.S. Drug Enforcement Administration (DEA) have guarded controlled substances zealously since the inception of the Controlled Substances Act (CSA), passed in the 1970s. However, the coronavirus (COVID-19) pandemic challenged nearly all of society’s conventional protocols, and the federal government responded to concerns that patients wouldn’t receive care by loosening its regulations for healthcare services. In 2020, the DEA permitted health providers to prescribe schedule II-controlled substances to patients via telehealth appointments instead of in-person visits. Now, two years later, the FDA has confirmed an Adderall shortage, which is a schedule II controlled substance that is in high demand and used to treat attention-deficit/hyperactivity disorder (ADHD). The Justice Department’s DEA division has initiated probes against various online mental health companies and worries that the drug is overprescribed and abused by young adults.
This year the Food and Drug Administration (FDA) has come under fire for its slow response to the nationwide baby formula shortage. In September 2022, FDA Commissioner Robert M. Califf authorized the release of an internal report. The report details how the baby formula shortage occurred, the FDA’s response to the shortage, and the challenges it faced in resolving the shortage. The report also revealed the changes in FDA regulatory procedure to ensure another shortage does not occur.
In October of 2021, the Department of Justice (“DOJ”) announced it would ramp up its enforcement against corporate repeat offenders of white-collar crimes and prioritize action against individual actors to promote accountability. The new measures implemented permit the DOJ to consider all prior wrongdoing by a corporation when deciding how to resolve a new investigation. Leniency programs of the past will not be extended to wrongdoers unless all believed participants, whether employees or executives, are disclosed. There has also been a shift from financial penalties to probationary settlements, which require companies not only to admit fault and pay fines but also to improve their monitoring of employees to deter crime. This may require outside monitoring to verify compliance, which can be burdensome and expensive.