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.
On Monday, October 31, the U.S. Federal Trade Commission (FTC) called on education technology provider Chegg, Inc. (Chegg) to bolster its data security, citing lax security practices that regulators said exposed the personal data of more than 40 million Chegg users. The exposed personal information included names, email addresses, passwords, and for certain users, sensitive scholarship data such as dates of birth, parents’ income range, sexual orientation, and disabilities.
Prescription drug price increases have long been a detriment to Americans. The Inflation Reduction Act (the Act) is in part designed to assist in this corporate pharmaceutical problem. This Act plans to do this through the implementation of seven major prescription drug provisions. Two of the major ones are requiring negotiations for certain drug prices by the federal government and limiting the monthly cost-sharing for insulin to $35. Through these changes along with various others, advocates hope that the burden will be lifted off Medicare beneficiaries. It has also been estimated that the Act will work to reduce the federal deficit by $237 billion over 10 years (2022-2031).
A decision filed October 19, 2022 by the Fifth Circuit Court of Appeals has vacated a payday lending rule put in place by the Consumer Financial Protection Bureau (CFPB). The rule was put in place to prevent predatory lending practices and unfair practices in their collection. The court decision was not based on the rule being unconstitutional but rather based in how the bureau is funded. The decision has overreaching implications on the future enforcement of CFPB rules.
The Fédération Internationale de Football Association (FIFA) deserves praise for growing the beautiful game of soccer since their founding in 1904; however, today the international governing body needs fixing. FIFA exists to govern football and to develop the game around the world. While FIFA preaches access and inclusivity, it has been plagued by corruption from the inside.
On October 20, 2022, the panel that reviews foreign investment in the United States for national security concerns published its first ever enforcement guidelines. The Committee on Foreign Investment (CFIUS) in the United States, has never had written guidelines on this topic. While this is the first guidance issued by CFIUS, the guidelines reflect the increased focus on monitoring and enforcement which has been evident since the passage of the Foreign Investment Risk Review Modernization Act of 2018. This continues the trend toward more enforcement relating to foreign investments and more concern surrounding compliance with terms of agreements meant to mitigate national security risks.
More than 2,500 government officials ranging from the Commerce Department to the Treasury Department reported owning stock in companies whose share prices correspond to decisions made by their respective agencies. With obvious conflicts of interest arising, what has happened, and what are some major takeaways from this investigative report?
In an action to keep company executives in check, the Justice Department (DOJ), created a policy where executives and compliance chiefs sign and personally attest to the effectiveness of their compliance programs. The individuals would therefore be held personally liable for their roles in the company’s wrongdoing. The DOJ and Google had a pending dispute, which was due to Google’s non-compliance with assisting authorities in an investigation. The DOJ and Google reached an agreement, with a stipulation attached, resolving the dispute over Google’s loss of data responsive to a 2016 search warrant. In the stipulation, Google has said that it has spent over 90 million dollars on additional systems and resources to improve its compliance programs, including an agreement to allow an Independent Compliance Professional to serve as a third party to monitor that Google is fulfilling its compliance legal obligations. This policy, as already seen in the settlement with Google, is forcing compliance to become a top-tier concern for big companies or face serious consequences.
The Centers for Medicare and Medicaid Services (CMS) manages an oversight program for nursing homes known as the Special Focus Facilities (SFF) program. Nursing homes that are placed in the program have almost double the deficiencies as other nursing homes, more serious issues in terms of injury and persistent problems that are never addressed. On October 21, 2022, CMS issued a press release regarding changes to its SFF program. The new changes will increase accountability for these facilities and encourage them to make quicker improvements. This action comes following the Biden-Harris Administration’s promise to increase safety and quality of care in poor-performing nursing homes.
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.