Insights

In response to the ongoing conflict in Ukraine and to exert further pressure on Russia, the EU enacted its 14thsanctions package against Russia on June 24, 2024. The new package comes after months of negotiations between Member States, and follow, but in many ways expand upon, those passed by the United States and the UK last week (see Crowell’s Alert on those developments here). 

With the increase in state-federal collaboration, now is the time to ensure that your company is in the best position to engage with and address potential regulatory enforcement actions. In light of the uptick in intergovernmental investigative and enforcement collaboration, namely among federal agencies such as the Department of Justice (DOJ), and individual state authorities like state attorneys general offices (AGs), AGs are growing their enforcement capacity and increasing their activity in areas that have historically been left to federal agencies.

In a recent development that underscores the ongoing debate over diversity, equity, and inclusion (DEI) initiatives in the United States, a group of 21 Republican State Attorneys General spearheaded by Tennessee Attorney General Jonathan Skrmetti has challenged the American Bar Association's (ABA) Standard 206 on Diversity and Inclusion. In a letter sent to the ABA in early June, the Republican AG group argues that the ABA Standard and its proposed revisions are unlawful due to the Supreme Court's ruling in Students for Fair Admissions, Inc. v. President & Fellows of Harvard College (SFFA).

On June 26, 2024, a 6-3 majority of the U.S. Supreme Court narrowed the scope of federal bribery law by ruling that 18 U.S.C. § 666 does not cover gratuities provided to officials for past acts. The Court held that Section 666, which outlaws bribery of state and local officials when federal funds are involved, does not extend to “gratuities” that follow an official act, in large part because regulation of such gifts is a matter of state and local law.

The Department of Defense (DoD) recently announced that it seeks public comments on a proposed change to the contractor business systems regime.  The proposed rule would amend the Defense Federal Acquisition Regulation Supplement (DFARS) by replacing the phrase “significant deficiency” with the new defined term “material weakness,” to mean “a deficiency or combination of deficiencies in the internal control over information in contractor business systems, such that there is a reasonable possibility that a material misstatement of such information will not be prevented, or detected and corrected, on a timely basis.”  In addition, the term would provide that a “reasonable possibility exists when the likelihood of an event occurring is— (1) Probable; or (2) More than remote but less than likely.” 

As reported in earlier Client Alerts, on November 7, 2023, the Federal Trade Commission challenged 100 patents as improperly listed in the Food and Drug Administration’s “Approved Drug Products with Therapeutic Equivalence Evaluations” publication, commonly known as the Orange Book. The FTC sent warning letters to ten drug and medical device manufacturers identifying patents for inhalers, autoinjectors and anti-inflammatory multi-dose bottles that the FTC believes are improperly listed. In response, some manufacturers withdrew their patents, and others agreed to cap certain out-of-pocket costs for their drugs, resulting in a “victory lap” of media activity from the FTC in April.

On June 17, 2024, the Department of Justice (DOJ) announced a $11.3 million False Claims Act (FCA) settlement that touches on two key enforcement priorities:  the DOJ’s Civil Cyber-Fraud Initiative and pandemic-related fraud.  This settlement, the largest under the Civil Cyber-Fraud Initiative to date, resolved allegations that Guidehouse Inc. (Guidehouse) and its subcontractor, Nan McKay and Associates (Nan McKay), violated the FCA because they failed to conduct pre‑production cybersecurity testing on New York State’s Emergency Rental Assistance Program (ERAP) technology product before public launch, and that Guidehouse used an unapproved third-party data cloud software program to store personally identifiable information (PII).

On May 30, 2024, the Department of Defense (DoD) issued a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to implement Section 803 of the 2023 National Defense Authorization Act, which modified 10 U.S.C. § 3455 to provide additional guidance regarding data requirements needed to support determinations of commerciality and price reasonableness under procurements for major weapon systems.  The rule applies to products that (i) have not previously been deemed commercial by the DoD; and (ii) are proposed as either a subsystem of a major weapon system or as a component or spare part of a major weapon system or subsystem. 

A warning letter posted by the Food and Drug Administration (FDA) on June 18, 2024 offers a first glimpse into how FDA may enforce its new regulatory scheme for products that fall within the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)’s purview. While MoCRA was enacted in December 2022 and many of its provisions became enforceable on December 29, 2023, until now, many have wondered how FDA will exercise its new enforcement powers.

Momentum is building for the US BIOSECURE Act, and it is becoming more and more likely that it will soon become law. It may significantly impact pharmaceutical and biotechnology companies and supply chains, particularly if they or their customers do business with the U.S. Federal Government. It is therefore important to prepare now to avoid potentially serious adverse effects.

Text messages and other non-email, electronic communications have become increasingly important in securities fraud matters. These communications are often sent from personal mobile devices and often provide key evidence.  It has become clear that the most interesting, and sometimes most problematic, communications often do not take place via email.

On August 1, 2024, Nondiscrimination on the Basis of Sex in Education Programs or Activities Receiving Federal Financial Assistance, one of the final Title IX regulations of the U.S. Department of Education released on April 19, 2024, will go into effect. The new regulations address the previous administration’s rollback of Title IX protections, and include, among other things, an expanded definition of sex discrimination that provides new protections for LGBTQ+ individuals against discrimination on the basis of sexual orientation and gender identity. For example, the new rules prohibit schools that receive federal funding from barring transgender students’ use of pronouns that correspond to their gender identities, or denying transgender students access to facilities, like locker rooms and restrooms, that match their gender identities. Other notable changes in the new regulations include the following: (1) protection from all sex-based harassment and discrimination, including that based on sex stereotypes, sexual orientation, gender identity, or pregnancy or related conditions; (2) broadening the definition of “hostile environment” harassment to include conduct that is so severe or pervasive that it limits or denies a person’s ability to participate in the education program or activity; (3) increased accountability by requiring schools to take prompt and effective action to end any sex discrimination in their education programs or activities, prevent reoccurrence, and remedy its effects; and (4) protection against retaliation for students, employees, and others who exercise their Title IX rights.

On June 20, 2024, the U.S. Department of Commerce’s Bureau of Industry and Security (BIS) announced a Final Determination, pursuant to the Securing the Information and Communications Technology and Services Supply Chain (ICTS) regulations, prohibiting Kaspersky Lab, Inc., the U.S. subsidiary of a Russia-based anti-virus software and cybersecurity company, from providing anti-virus software and cybersecurity products or services in the United States or to U.S. persons (wherever located) because it poses undue and unacceptable risk to U.S. national security. The prohibition also applies to Kaspersky Lab, Inc.’s affiliates, subsidiaries and parent companies (collectively Kaspersky). This is the first time that BIS’s Office of Information and Communications Technology and Services (OICTS) has issued a determination pursuant to the ICTS regulations.

Universal Music Group, Sony Music, and Warner Music Group., represented by the Recording Industry Association of America (RIAA), have sued online music AI generators, Suno AI (“Suno”) and Udio AI (“Udio”), for alleged copyright infringement, accusing them of replicating their artists’ music using AI technology. The Suno complaint is filed in the U.S. District Court for the District of Massachusetts, and the Udio complaint is filed in the U.S. District Court for the Southern District of New York.  The lawsuits also target Alphabet Inc., Google's parent company. The RIAA is asking for damages amounting to up to $150,000 per infringing song, which could amount to hundreds of millions of dollars. 

The Cost Accounting Standards Board (CASB) recently announced that it seeks public comments on “whether and how” to amend the rules to clarify whether the CAS apply to indefinite value contract vehicles (or IDVs, otherwise known as indefinite-delivery / indefinite-quantity, or IDIQ, contracts).  Comments are due no later than August 19, 2024.  The full text of the notice is available here.  The CASB also published a paper discussing six possible approaches and the criteria it will use to evaluate those approaches, but welcomed the public to identify alternatives for the CASB to consider. 

The Judgment of the Brussels Court of Appeal is the latest development in the saga in Belgium where a Belgian parallel importer, PI Pharma NV, imported a generic Sandoz product from the Netherlands, repackaged and rebranded them, and placed them on the Belgian market alleging they were a Novartis’ originator product.

On June 6, 2024, the General Services Administration (GSA) issued a final rule seeking to minimize the use of single-use plastic (SUP) packaging materials in goods procured through the Federal Supply Schedules (FSS).  Rather than instituting an outright ban on SUP packaging, GSA opted to incentivize FSS contractors to offer SUP-free products through providing a special icon in GSA Advantage for FSS contractors self-certifying that their products are SUP-free.  The final rule explains that the SUP-free icon is intended to act “as an important discriminator when buyers are making purchasing decisions” so that FSS contractors that adopt this voluntary measure will become more marketable in the federal procurement space.  While application of the final rule is limited to purchases from the FSS, GSA believes that the final rule will “also create positive spillovers as non-FSS contracting firms adopt similar policies to compete with FSS contractors in non-FSS markets.”  GSA also explained that the final rule is an “initial step” in providing more sustainable packaging and that the goal is to encourage other federal agencies to eventually adopt these practices into other government contracts.  Importantly, GSA will rely on self-certification that identified products are SUP-free and will not require any third-party verification, as the increased regulatory burden could discourage participation of small businesses.  The final rule is effective starting July 8, 2024.

On June 13, 2024, The Supreme Court ruled in Starbucks v. McKinney that the National Labor Relations Board (“Board”) must meet the same four-part test that other litigants must satisfy in order to obtain a preliminary injunction. This holding resolves a split amongst the circuit courts, some of which have applied a “less exacting” two-factor test to preliminary injunctions under Section 10(j) of the National Labor Relations Act (“NLRA”).

As the world grapples with elections, continuing inflation, and political conflicts, world leaders are attempting to negotiate two legally binding treaties aimed at solving global health and environmental challenges. The recent negotiations of the World Health Organization’s (WHO) Pandemic Treaty and the United Nation’s (UN) Plastics Treaty – which seemingly went unnoticed in busy news cycles – offer crucial insights on multilateralism and the role that industry can play in shaping global policy.

On May 30, 2024, the Department of Defense (DoD) issued a final rule implementing Section 844 of the Fiscal Year (FY) 2021 National Defense Authorization Act (NDAA) and Section 854 of the FY 2024 NDAA by amending DFARS 225.7018-2 and accompanying DFARS clause 252.225-7052, which restrict DoD from acquiring certain metals and magnets from “covered countries” of Iran, North Korea, Russia, and China, to prohibit even earlier inputs in the supply chain from occurring in these countries.  Despite comments discussing the infancy of the domestic market for many “covered materials”—defined as samarium-cobalt magnets, tantalum metals and alloys, tungsten metal powder, and tungsten heavy alloy or any finished or semi-finished component containing tungsten heavy alloy—the final rule expands the restrictions on sourcing covered materials from covered countries.  Currently, the rule requires that covered materials not be melted or produced in covered countries but, effective January 1, 2027, the updated rule prohibits covered materials being mined, refined, separated, melted or produced in one of the covered countries. The expansion of the focus of the prohibition all the way back to where these materials were mined is consistent with the U.S. government’s effort to develop the domestic industrial base for and encourage on-shoring of critical minerals, magnets, and metals.