Health Law Advisor

On September 16, 2025, the U.S. Food and Drug Administration (FDA) released more than 60 warning letters sent to specific pharmaceutical manufacturers, alleging misbranding of a particular drug through direct-to-consumer (DTC) advertisements in violation of the federal Food, Drug, and Cosmetic Act (FDCA). The warning letters issued largely from the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).

The FDA also released nearly 40 untitled letters sent to specific drug manufacturers from its Office of Prescription Drug Promotion on September 9 and 23, similarly informing them that one or more direct-to-consumer TV ads misbrands a specific drug.

These actions follow the September 9th announcement that the U.S. Department of Health and Human Services (HHS) and the FDA would be targeting “misleading” DTC pharmaceutical advertisements—the same day that a presidential memorandum directed HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Martin A. Makary to act.

The letters also reflect a broader shift in the FDA’s oversight of pharmaceutical advertising, particularly in DTC channels. With regulators taking a more aggressive posture across both broadcast and social media platforms, companies should be prepared for shifting regulatory requirements and heightened enforcement risk.

On January 8, 2025, Massachusetts Governor Maura Healey signed into law House Bill No. 5159, “An Act enhancing the health care market review process” (“H. 5159”), which was passed by the Massachusetts legislature in the last few days of 2024. The bill, which takes effect April 8, will implement greater scrutiny of certain health care entities and affiliated companies—including private equity sponsors, significant equity investors, health care real estate investment trusts (“REITs”), and management services organizations (“MSOs”)—as well as pharmaceutical companies and pharmacy benefit management companies (“PBMs”) in the Commonwealth. 

The passage of H. 5159 follows debate between the House and Senate earlier in 2024 over similar bills, which failed to pass during the summer legislative session. Notably, similar bills included debt limitations on certain private investor-backed entities and bans of certain private equity investments, as well as significant restrictions on the MSO business model. However, these restrictions (among various others) were stripped from H. 5159.

Although H. 5159 has widespread implications for health care entities in the Commonwealth, a significant portion of the bill is clearly aimed at increasing regulatory oversight of for-profit-backed health care organizations through increased regulatory oversight of certain health care transactions and expanded reporting obligations. The bill also seeks to contain health care costs, including by increasing oversight of pharmaceutical company and PBM arrangements.

On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) released final guidance on informed consent for clinical investigations (“Final Guidance”). This update follows FDA’s draft guidance, which was issued in July 2014, and supersedes the FDA’s “A Guide to Informed Consent,” which was issued in September 1998. The Final Guidance is intended to assist clinical research stakeholders, such as institutional review boards (“IRBs”), investigators, and sponsors, in complying with FDA’s informed consent regulations for clinical ...