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On December 16, 2025, the U.S. National Institute of Standards and Technology (“NIST”) published a preliminary draft of the Cybersecurity Framework Profile for Artificial Intelligence (“Cyber AI Profile” or “Profile”).  According to the draft, the Cyber AI Profile is intended to “provide guidelines for managing cybersecurity risk related to AI systems [and] identify[] opportunities for using AI to enhance cybersecurity capabilities.”  The draft Profile uses the existing voluntary NIST Cybersecurity Framework (“CSF”) 2.0 — which “provides guidance to industry, government agencies, and other organizations to manage cybersecurity risks” — and overlays three AI Focus Areas (Secure, Detect, Thwart) on top of the CSF’s outcomes (Functions, Categories, and Subcategories) to suggest considerations for organizations to prioritize when securing AI implementations, using AI to enhance cybersecurity defenses, or defending against adversarial uses of AI.  This draft guidance will likely be familiar to organizations that already leverage the CSF 2.0 in their cybersecurity programs and might be complimentary to existing frameworks that organizations already have in place.  Even so, the outcomes are designed to be flexible such that a range of organizations (with mature or novel programs) can leverage the guidance to help manage AI-related cybersecurity risk.  Continue Reading NIST Publishes Preliminary Draft of Cybersecurity Framework Profile for Artificial Intelligence for Public Comment

In the 2024 election cycle, super PACs spent a reported $2.7 billion at the federal level, up from roughly $1.4 billion in 2022. And in 2025, super PACs poured tens of millions into state and local races, including the New Jersey gubernatorial race and the New York City mayoral…

Continue Reading Forming and Operating Super PACs: A Practical Guide for Political Consultants in 2026

The California Civil Rights Council and the California Privacy Protection Agency have recently passed regulations that impose requirements on employers who use “automated-decision systems” or “automated decisionmaking technology,” respectively, in employment decisions or certain HR processes. On the legislative side, the California Legislature passed SB 7, which would impose additional obligations on employers who use these technologies; the bill is currently on the Governor’s desk. And, the Governor has signed SB 53, which provides certain employee whistleblower rights with respect to AI safety. Below, we discuss some of the key requirements in the new regulations and legislation.Continue Reading Navigating California’s New and Emerging AI Employment Regulations

In a recently announced settlement agreement with the U.S. Department of Justice (“DOJ”), Illumina, Inc. (“Illumina”) agreed to pay $9.8 million to resolve claims arising from alleged cybersecurity vulnerabilities in genomic sequencing systems that the company sold to federal agencies.  The case is the latest in a series of False Claims Act (“FCA”) settlements under the current administration that evidence DOJ’s continued focus on cybersecurity obligations for government contractors, particularly those that maintain sensitive data and personal information on behalf of federal customers.Continue Reading Latest Cybersecurity False Claims Act Settlement with Diagnostics Provider Focuses on Sensitive Health Systems

On July 29, 2025, Attorney General Pam Bondi issued a memorandum titled “Guidance for Recipients of Federal Funding Regarding Unlawful Discrimination.”  The memorandum purports to offer “guidance” and “Best Practices” to recipients of federal funding, including “non-binding suggestions to help entities comply with federal antidiscrimination laws and avoid legal pitfalls.”  The Attorney General’s memorandum follows Executive Order 14173 (“Ending Illegal Discrimination and Restoring Merit-Based Opportunity”), which calls for “ending illegal discrimination and preferences, including DEI” in the private sector, as well as two “technical assistance” documents titled “What You Should Know About DEI-Related Discrimination at Work” and “What To Do If You Experience Discrimination Related to DEI at Work” issued by the Equal Employment Opportunity Commission (“EEOC”).  We previously discussed EO 14173 here and the EEOC technical assistance here.Continue Reading DOJ Issues Memorandum for Federal Funding Recipients Addressing “Unlawful Discrimination” Practices

Yesterday, Texas governor Greg Abbott signed into law S.B. 25, which requires food products containing any of 40+ specified ingredients to bear a warning label. This follows Texas’s enactment of S.B. 314 in late May, which prohibits Texas school districts and open-enrollment charter schools from providing free or reduced-price meals that contain any of 17+ specified ingredients. As of the date of this writing, Louisiana S.B. 14, which would impose (1) disclosure requirements for any food product sold in the state that contains specified ingredients, and (2) a ban on the use of certain ingredients in school meals, is sitting on the governor’s desk. It will become law if he signs it or takes no action by June 25. These actions are part of a larger trend of increased scrutiny of food and color additives, as we previously reported and which is a significant feature of the Make America Healthy Again (“MAHA”) Commission’s Assessment released on May 22, 2025.

Texas S.B. 25

S.B. 25 requires human food products containing any of 40+ specified ingredients to bear the following warning label: “WARNING: This product contains an ingredient that is not recommended for human consumption by the appropriate authority in Australia, Canada, the European Union, or the United Kingdom.” Violators may be subject to a fine not to exceed $50,000 per day for each distinct food product in violation of the requirement.

The ingredients subject to the warning label requirement are the FD&C colors (i.e., Blue Dye No. 1, Red Dye No. 40, etc.) and numerous other ingredients including bleached flour, bromated flour, azodicarbonamide, butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), potassium bromate, and propylparaben. Although the sweeteners aspartame, sucralose, acesulfame potassium (as well as high fructose corn syrup) were listed in earlier drafts of the bill, they are not included in the bill ultimately signed into law. 

The warning requirement will apply only to food product labels “developed or copyrighted on or after January 1, 2027.” Thus, it appears that food labels in use or even just copyrighted before that date could continue to be used for extended periods of time beyond that date.Continue Reading Texas Also Enacts Bans on Certain Ingredients in School Meals; Similar Louisiana Bill Progresses

On 23 January 2025, we hosted the 2025 edition of the Covington European Life Sciences Symposium. The Symposium brought together colleagues from London, Brussels, Frankfurt and Dublin with our industry connections to explore the evolving challenges and opportunities facing the European life sciences sector.

Throughout the day our speakers shared their perspectives on a range of legal, regulatory, and business trends, including the evolving regulatory frameworks in the EU and UK; information exchange in ongoing collaboration; investigations and whistleblowing; key ESG topics, and the complexity of options to acquire in pharma deals.

We have set out some of the discussion from the sessions below.

European Life Sciences – The Changing Landscape for Pharma and Biotech

Grant Castle, Head of Covington’s European Life Sciences Regulatory Practice, Peter Bogaert, Marie Doyle-Rossie and Anna Wawrzyniak kicked off with a discussion about the Changing Landscape for Pharma and Biotech.

The UK and EU both aim to deliver access to innovative and transformative medicines and foster international competitiveness in the life sciences industry. Despite the practical challenges faced by the UK Medicines and Healthcare products Regulatory Agency (MHRA) in recent years, it has emerged as an ambitious regulator and is establishing innovative regulatory frameworks, including an international reliance scheme (see our update here), point of care manufacturing regulations, and the relaunch of the Innovative Licensing and Access Pathway (ILAP).

The EU is also pursuing a wave of legislative reform, including wide ranging revisions to the EU’s pharmaceutical legislation, the EU’s supplementary protection certificates (SPC) rules, and proposals for a compulsory licensing scheme.

There can sometimes be a tension between the UK’s and EU’s aims and the practical impacts of regulatory reform, especially in the early stages of implementation.Continue Reading The Covington European Life Sciences Symposium 2025

With Election Day just weeks away, employers should quickly brush up on laws that permit employees to take time off to vote.  There is no federal law permitting time off to vote, but a majority of states and the District of Columbia have some form of voting leave law, with…

Continue Reading Is Your Workplace Election Ready?  Voting Leave Laws Across the States

June 27, 2024, Covington Alert

On June 25, 2024, the Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) announced that it has finalized Guidance for Industry (GFI) #276, Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs (Final Guidance). The Final Guidance replaces CVM’s draft guidance issued in November 2022. While CVM’s core recommendations remain the same, the Final Guidance clarifies the discussion and recommendations related to geographic locations from which Dirofilaria immitis (D. immitis) larvae used in trials should be sourced, laboratory dose confirmation studies, and field effectiveness studies for products intended to prevent heartworm disease. CVM’s stated overarching goal in making the revisions is to better align GFI #276 with current technology and veterinary epidemiology, including available diagnostic methodology. Drug sponsors who deviate from these recommendations are encouraged to discuss the deviations with CVM.

Background

On May 24, 2018, FDA published a Federal Register Notice requesting public input on possible alternative approaches for evaluating the effectiveness of heartworm disease prevention products for dogs. On its webpage announcing the final guidance, FDA explained that it asked for public input because of reports of lack of effectiveness and certain limitations of the effectiveness studies conducted to support product approval. FDA’s then-current recommendation for demonstrating the effectiveness of a new animal drug intended to prevent heartworm disease was for sponsors to conduct two laboratory dose confirmation studies and one multi-site field effectiveness study under the principles of Good Clinical Practice. FDA specifically requested input on the population level effectiveness endpoint, exposure to infective D. immitis larvae in field studies, outcome assessment in field studies, and laboratory study designs.Continue Reading FDA Issues Final Guidance on Demonstrating Effectiveness of Anthelmintics in Dogs

A recent decision by the Armed Services Board of Contract Appeals found the Navy liable to a commercial crane manufacturer for delay damages. In Konecranes Nuclear Equip. & Servs., LLC, ASBCA No. 62797, 2024 WL 2698011 (May 7, 2024), the Board reiterated the age-old lesson—you have to read the contract—and provided guidance about how to calculate the delay damages. Beyond that, the Board found apparent inspiration for part of its holding in an unlikely source: a classic song by the Rolling Stones.Continue Reading You Can’t Always Get What You Want: ASBCA Channels Rolling Stones and Awards Contractor $4.9 Million in Delay Damages