Insights

On September 9, 2025, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (HHS) issued a news release announcing an “aggressive[]” “crackdown” on direct-to-consumer pharmaceutical advertising. This release came on the heels of a Presidential Memorandum President Trump issued the same day directing HHS to “ensure transparency and accuracy in direct-to-consumer prescription drug advertisements,” and the FDA to “take action to enforce legal requirements that advertisements for prescription drugs be truthful and not misleading.”

On August 8, 2025, the Attorneys General of 23 Republican-led U.S. states (the “AGs”) sent a letter to Science Based Targets Initiative (“SBTi”), a U.K. non-profit climate organization, expressing concern with the SBTi’s climate initiatives.[1]SBTi had previously received a subpoena from Florida Attorney General James Uthmeier in connection with his office’s investigation into what he described as a “climate cartel,” which he alleges includes SBTi and CDP (formerly the Carbon Disclosure Project).[2]

California Governor Gavin Newsom has until October 12, 2025, to sign into law a first-in-the-nation bill that will, if enacted, likely impose significant regulatory obligations and litigation risk on companies deploying AI chatbots in California.

Although the Supreme Court’s 2014 decision in Alice v. CLS Bank and its progeny affected the issuance and enforcement of software patents and led to a major shift in U.S. patent policy, software patents still have value today and such protection therefore should be pursued.

On September 11, 2025, the Environmental Protection Agency (EPA) asked the D.C. Circuit to vacate regulations for four types of polyfluoroalkyls (known collectively as “PFAS”) in drinking water. The motion for partial vacatur marks a significant reversal in the agency’s policy, as the EPA had previously vigorously defended legal challenges to the first-of-their-kind standards in federal court for the past two years. See American Water Works Association, et al. v. EPA, case no. 24-1188 and consolidated cases (D.C. Cir. filed June 7, 2024). Just this month, the case was given the green light to proceed, after being held in abeyance (at the request of both parties) so that the Trump administration could determine how it wished to proceed. The change signals a willingness on the part of the administration to act on previously issued non-legally binding announcements of forthcoming changes to Biden-era rules and may also serve as a harbinger for how the new administration will tackle PFAS under other statutes, such as the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA).

On August 19, 2025, the U.S. Senate Committee on Finance (“Senate Finance Committee”) sent Paul Atkins, Chairman, U.S. Securities and Exchange Commission (“SEC”) a letter calling on the SEC to investigate White River Energy Corp (“White River”). In the letter, the Senate Finance Committee confirmed a criminal investigation into White River related to the sale of so-called “tribal tax credits” that according to both Congress and the IRS, do not exist. The letter further states that White River allegedly earned millions of dollars selling these credits and has not been forthcoming with investors regarding the existence of the criminal investigation. According to the Senate Finance Committee, White River has failed to file financial disclosure documents with the SEC since March 15, 2024, missing six consecutive reporting periods. The letter instructs White River to disclose the existence of the DOJ criminal tax investigation, and calls on the SEC to take action if White River fails to do so.

On September 4, 2025, the Small Business Administration’s (SBA) Office of Hearings and Appeals (OHA) granted an appeal challenging SBA’s determination that a service-disabled veteran did not control an entity applying for Service-Disabled Veteran-Owned Small Business (SDVOSB) status based on a minority owner’s ability to block certain actions in the matter of VSBC Appeal of: Blue Skye Foods, LLC, SBA No. VSBC-442-A.

On August 28, the U.S. Department of Commerce Bureau of Industry and Security (BIS) published a final rule that modifies the Export Administration Regulations (EAR) to reduce the number of export control restrictions on Syria, in alignment with Executive Order 14312, Providing For The Revocation of Syria Sanctions. The key adjustments made by this rule include the addition of new or expanded license exception eligibility for exports and reexports to Syria (which significantly broadens the number of items that can be exported or reexported to Syria) and the adoption of more permissive license review policies for exports and reexports to Syria.

About one year ago, the European Court of Justice (CJEU) ruled in its landmark Illumina/Grail judgment that the European Commission could not accept merger referrals from national competition authorities under Article 22 of the EU Merger Regulation (EUMR) unless those authorities had jurisdiction to review the transaction themselves (see our previous alert).

On September 9, 2025, GSA released version 1 of the FAR Companion, a living resource guide aimed primarily at assisting federal acquisition professionals. The FAR Companion is designed to provide guidance and recommendations to acquisition professionals to better understand the FAR and related procurement principles for planning, awarding, managing, and closing out contracts. It consolidates practitioner insights, innovation and vendor engagement strategies, handbooks, training materials, and problem-solving ideas into one source.

On September 10, 2025, the Department of Defense (DoD) published a final rule (CMMC Clause Rule) that will apply its much-anticipated Cybersecurity Maturity Model Certification program (CMMC) to DoD contractors and subcontractors. Under the CMMC Clause Rule, starting on November 10, 2025, DoD can include CMMC requirements—potentially including third-party cybersecurity assessments—in contracts that require the handling of Controlled Unclassified Information (CUI) or Federal Contract Information (FCI).

On September 9, 2025, the California Privacy Protection Agency (“CPPA”), along with California Attorney General Rob Bonta, Colorado Attorney General Phil Weiser, and Connecticut Attorney General William Tong, (collectively the “Coalition”) announced a joint investigative sweep (the “Sweep”) into businesses refusing to honor consumers' requests to opt-out of the sale of their personal information submitted via Global Privacy Controls (“GPCs”). This Sweep is another action in a growing trend of multi-state cooperation in data privacy enforcement activities. Given the continued lack of a federal data privacy law, state cooperation and enforcement activities are expected to continue.

On September 5, 2025, the Federal Trade Commission (“FTC”) withdrew its appeals of decisions issued by Texas and Florida federal district courts, which enjoined the FTC from enforcing a nationwide rule banning almost all noncompete employment agreements. Companies, however, should not read this decision to mean that their noncompete agreements will no longer be subjected to antitrust scrutiny by federal enforcers. In a statement joined by Commissioner Melissa Holyoak, Chairman Andrew Ferguson stressed that the FTC “will continue to enforce the antitrust laws aggressively against noncompete agreements” and warned that “firms in industries plagued by thickets of noncompete agreements will receive [in the coming days] warning letters from me, urging them to consider abandoning those agreements as the Commission prepares investigations and enforcement actions.”

The Best Lawyers in America 2026 Recognizes 43 Crowell & Moring Attorneys, One Selected as Lawyer of the Year

In 2023, California passed two landmark laws—SB 253, the Climate Corporate Data Accountability Act; and SB 261, the Climate-Related Financial Risk Act—that will require large public and privately-held entities doing business in California to comply with sweeping disclosure requirements regarding their direct and indirect greenhouse gas emissions and their climate-related financial risks. California subsequently passed SB 219, which updated certain deadlines and requirements of the laws (collectively, the “Climate Disclosure Laws”).

CMS is well underway in initiating and conducting its Risk Adjustment Data Validation (RADV) audits of Medicare Advantage (MA) organizations for PY 2019, and PY 2020 audit notices are likely to arrive by the end of September. The timing for subsequent PY audits is less clear, but notices will likely be coming soon given CMS’s announced plans to complete all remaining audits by early 2026, including all contracts for PY 2020 and beyond. This approach marks a significant deviation from the agency’s prior policy of reviewing only a fraction of contracts and at a much slower pace.

The System for Award Management (SAM, available at sam.gov) is set to incorporate Revolutionary FAR Overhaul (RFO) changes as early as the first quarter of 2026. The RFO process, which began earlier this year, will trigger matching changes to representations and certifications in SAM.gov.

On August 29, 2025, the Department of Justice (DOJ) and the Department of Homeland Security (DHS) launched a cross-agency Trade Fraud Task Force to expand efforts to target importers and other parties committing trade-related fraud. As stated in a press release issued on August 29, the Task Force will augment the existing coordination mechanisms within the DOJ and DHS, for instance through partnerships with CBP and Homeland Security Investigations, to “aggressively” take enforcement measures against parties that commit tariff evasion or attempt to smuggle prohibited goods into the U.S.

Nearly a decade and a half after the passage of the Leahy-Smith America Invents Act (“AIA”), the Federal Circuit finally had its first occasion to review an appeal of a derivation proceeding that was litigated before the Patent Trial and Appeal Board (“Board”) in Global Health Solutions LLC v. Selner. This case provides helpful guidance for patent litigators regarding the proper legal framework in a derivation proceeding and serves as a reminder that patent applications should be filed as soon as possible. As the facts of this case show, it is important that inventors retain documents and other evidence of the conception of their invention, as well as its communication to others, should there be any challenge to their invention.

On August 22, 2025, the Small Business Administration (SBA) published a proposed rule that would raise the receipts-based small business size standards across 259 industries and the asset-based size standard across 4 industries. The proposed rule aims to provide greater opportunity for growing small businesses to retain their small business status longer and continue to benefit from SBA loan programs and federal contracting opportunities reserved for small businesses.