Health Law Advisor

The federal government is pursuing restrictions on gender-affirming care through a coordinated, multifaceted enforcement strategy.

For health care providers, understanding both the tools being deployed and the methods providers are using to respond is essential to compliance planning.

Jennifer Nelson Carney, Member of the Firm, examines the federal enforcement mechanisms and discusses how health care organizations are responding to coordinated federal challenges.

The first half of 2026 has seen active U.S. Food and Drug Administration (FDA) enforcement across multiple regulatory domains. For regulated companies, monitoring the FDA’s enforcement priorities is critical to compliance and audit readiness.

Megan Robertson, Member of the Firm, examines the FDA’s recent enforcement actions, identifies six trends in the agency’s regulatory approach, and offers practical guidance for in-house counsel.

Key Takeaways

• The FDA is monitoring websites, social media, podcasts, and online storefronts for marketing claims that may be inappropriate based on a company’s regulatory status.
• The most prominent trend is continued enforcement against online telehealth platforms offering compounded GLP-1s. Companies must clearly distinguish health care services from drugs being compounded and sold by pharmacies.
• The Center for Drug Evaluation and Research is actively enforcing current Good Manufacturing Practice compliance. Recalls alone do not satisfy the FDA’s remediation expectations; companies must demonstrate comprehensive, root-cause corrections.
• Food facilities face enforcement action for inadequate Foreign Supplier Verification Programs on imported products, including produce, rice, matcha powder, and green tea.
• Form 483 responses are receiving heightened FDA scrutiny. Medical device manufacturers should prepare for potential increased Quality Management System Regulation enforcement as the year progresses.
• These warning letters were issued under the former FDA commissioner. In-house counsel should monitor for potential shifts in enforcement priorities under new leadership as the year progresses.

From our Thought Leaders in Health Law video series: On March 31, 2025, the U.S. District Court for the Eastern District of Texas ruled that the Food and Drug Administration (FDA) lacks the statutory authority to regulate laboratory-developed tests (LDTs).

The court’s judgment vacates the agency’s controversial final rule of May 6, 2024 (the “Final Rule”), regulating LDTs as medical devices, just weeks before the Final Rule’s initial implementation deadline and remands the issue back to the FDA for further consideration.

From our Thought Leaders in Health Law video series: In today's complex and rapidly evolving health care landscape, navigating the path of expanding or selling a business requires a nuanced understanding of the intricate state and federal regulatory frameworks.

With states increasingly imposing legislative oversight to safeguard competition, care access, and quality, it's crucial for health care providers, private equity firms, and management organizations to have a strategic partner adept at handling these challenges.

States are imposing prior approval or prior review legislation to allow for more visibility regarding proposed transactions. Much of the legislation seeks to increase oversight of health care entity relationships with management companies and private equity firms.

What does this mean for you?

From our Thought Leaders in Health Law video series: The U.S. Supreme Court’s 2022 decision in Dobbs v. Jackson Women’s Health Organization to eliminate the federal constitutional right to abortion continues to alter the legal landscape across the country.

On April 26, 2024, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights published a final rule entitled the “HIPAA Privacy Rule to Support Reproductive Health Care Privacy” (the “Final Rule”).

The Final Rule—amending the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”) under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as well as the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009—strengthens privacy protections related to the use and disclosure of reproductive health care information. HIPAA’s Privacy Rule limits the disclosure of protected health information (PHI) and is part of HHS’s efforts to ensure that patients will not be afraid to seek health care from, or share important information with, health care providers.

What are the key takeaways from the Final Rule?

From our Thought Leaders in Health Law video series: Braidwood v. Becerra represents a significant legal challenge to the Affordable Care Act’s (ACA’s) preventive services coverage provision, which requires private health insurance to cover various clinical preventive services, including immunizations; services rated A or B by the U.S. Preventive Services Task Force; and women's preventive services, such as contraceptives.

Employer plaintiffs have contested the law on moral and religious grounds, particularly objecting to coverage for HIV prevention medication ...

From our Thought Leaders in Health Law video series: The Inflation Reduction Act (IRA) introduces significant changes in prescription drug pricing, including the establishment of the Medicare Drug Price Negotiation Program and the Medicare Prescription Drug Inflation Rebate Program to control drug prices.

The IRA includes a redesign of the Medicare Part D benefit, which began with the announcement of 10 Medicare Part D drugs open for negotiation. This video highlights the challenges and complexities during the multi-year IRA implementation and emphasizes the penalties for ...

From our Thought Leaders in Health Law video series:  The U.S. Department of Justice (DOJ) collected $5.6 billion in False Claims Act recoveries in fiscal year (FY) 2021.

That is over twice as much as 2020, and a record 90 percent of the total was collected from the health care and life sciences industries.

From our Thought Leaders in Health Law video series:  Is your organization ready for the No Surprises Act (NSA)? The law goes into effect January 1, 2022, and contains a new federal ban on surprise billing as well as new disclosure requirements.

The NSA applies to certain payors, providers, facilities, and ancillary service entities that support patients who receive emergency services or other non-emergency services at certain facilities, such as hospitals, hospital outpatient departments, and ambulatory surgical centers.