All Perspectives

For the past several years, the use of contract sales forces by pharmaceutical and device manufacturers and other suppliers has been under a heightened enforcement spotlight.

The California Department of Public Health (CDPH) denied two petitions to amend the hospital licensing regulations in Title 22 of the California Code of Regulations to allow advanced practice providers to be members of organized medical staffs in general acute care hospitals.

For the first time in 26 years, the US Food and Drug Administration (FDA) has proposed adding a new active ingredient to the list of permissible sunscreen actives in the United States.

Partner J. Michael Showalter was quoted on how non-governmental organizations focused on climate advocacy are expected to intensify litigation efforts this year against major oil and gas companies, regardless of multiple state court losses in 2025.

Life Sciences Industry Group Co-Leader Stephanie Trunk was quoted on Medicare’s updated drug price negotiation program under the Inflation Reduction Act being implemented in 2026.

The 2025 holiday retail shopping season is nearly a wrap. Consumers will be on the hunt for year-end discounts, and gift card purchases likely will surge over the coming days.

ArentFox Schiff is pleased to announce that Ucheora Onwuamaegbu has been appointed president of the Silicon Valley Arbitration & Mediation Center (SVAMC).

In this episode of Five Questions, Five Answers, Birgit Matthiesen and Jessica DiPietro explore the historical context and implications of the Nixon Shock and the Trade Expansion Act, focusing on Section 232 investigations and their impact on US trade policy.

On December 18, President Trump issued an executive order (EO) directing the Attorney General to complete rulemaking to reschedule “marijuana” from Schedule I to Schedule III under the Controlled Substances Act (CSA) and to expand federal research and policy development on medical marijuana and hemp derived cannabinoids.

The Centers for Medicare & Medicaid Services (CMS) Innovation Center has announced the Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model, a 10‑year voluntary payment model that introduces outcome‑aligned payments (OAPs) to expand access to technology‑supported care for Medicare beneficiaries with common chronic conditions.

A magistrate judge of the US District Court for the District of Delaware issued a report and recommendation recommending the denial of the defendants’ Rule 12(b)(6) motion to dismiss SambaSafety’s Defend Trade Secrets Act (DTSA) claim arising from alleged misappropriation of driver compliance software and related data systems.

On December 19, New York Governor Kathy Hochul vetoed S8432/A8662, a bill to amend the New York LLC Transparency Act that would have decoupled it from the federal Corporate Transparency Act (CTA) definitions.

The past year has been unusually active on the health care antitrust front. Providers are pressing price-fixing and information-exchange theories against payers and claims intermediaries and a landmark class settlement moving into its implementation phase.

Many foreign nationals travel home during the holidays to visit family. Recent federal actions have significantly restricted international travel for some foreign nationals, creating a risk that some individuals could be stranded outside the United States for extended periods. These disruptions can affect both the individual and their US employer.

Headlines that Matter for Companies and Executives in Regulated Industries

The use of artificial intelligence (AI) to generate digital representations of real or fictional people — “AI avatars” — offers new ways to build brands, drive engagement, and grow revenue by accelerating content creation and lowering production costs. It also raises the following important legal considerations.

AFS Partners Susan Bart and Kevin Matz were quoted on the emerging gift tax reporting issues tied to new “Trump Accounts,” cautioning that routine family contributions could trigger onerous IRS Form 709 Gift and Generation-Skipping Transfer Tax filing obligations absent a legislative or regulatory fix comparable to the long-standing relief afforded to 529 plans.

Adopting an “AI policy” is critical for managing an organization’s use of artificial intelligence (AI) tools. A targeted AI policy can provide clear guardrails that can then be incorporated into organization-wide training but be prepared to pivot quickly as these technologies evolve.

Public-facing debates over pharmaceutical drugs and life sciences products are as pronounced as ever. Although the ongoing scuffle over Tylenol has received the most attention, similar controversies abound. Just last month, Aurinia Pharmaceuticals filed a defamation complaint against a now-resigned US Food and Drug Administration (FDA) official over critical statements made about one of its drugs.

The US state-level privacy law landscape continues to evolve at a very rapid rate. On January 1, 2026, new state privacy laws take effect in Indiana, Kentucky, and Rhode Island. Cure periods sunset throughout the year for state privacy laws in Connecticut, Delaware, Kentucky, Minnesota, and Montana, with additional large language model (LLM) disclosure changes also effective this summer.

AFS partner Kevin Matz and his co-author Shifra Herzberg summarize the IRS’s initial guidance on new “Trump accounts” created under IRC Section 530A to promote children’s long-term savings in his latest article for Wealth Management.

In recent months, three federal courts have refused to enforce expansive US Department of Justice (DOJ) administrative subpoenas issued to providers of gender-affirming care, concluding the subpoenas were issued for an improper purpose or exceeded the government’s statutory authority. These rulings are significant.

Partner Michelle Mancino Marsh was quoted on a Northern District of Illinois decision denying a temporary restraining order and potentially pausing Schedule A litigation in that District to reassess its use, a move that Michelle said could complicate anti-counterfeiting efforts.

On December 12, the Eleventh Circuit heard the much-anticipated oral arguments in United States ex rel. Zafirov v. Florida Medical Associates LLC concerning the constitutionality of the False Claims Act’s (FCA) qui tam provisions.

Kevin Timson talks with Mercer Capital Vice President David Harkins, who shares insights into automotive dealership valuation.