On January 27, 2026, the U.S. Department of Health and Human Services Office of Inspector General (the OIG) issued a Special Advisory Bulletin (the Bulletin) addressing the application of the federal anti-kickback statute (the AKS) to direct-to-consumer (DTC) prescription drug sales. 

The Bulletin, the OIG’s first Special Advisory Bulletin since September 2014, was issued in response to the proliferation of DTC programs. The Bulletin, which sets forth the framework under which a manufacturer’s DTC program presents a low risk of violating the AKS, is viewed by the growing DTC industry as favorable guidance. DTC programs offering modern weight-loss medications, such as GLP-1 drugs, are becoming increasingly popular, and the Bulletin provides a helpful framework to support the viability of these programs. 

Recent developments at the federal legislative and regulatory levels signal a significant shift toward greater transparency requirements in the pharmacy benefit management (PBM) industry.

Seven states have passed Extended Producer Responsibility (EPR) laws related to single-use packaging and plastic food serviceware, with other states considering similar legislation. The intent of these laws is to hold the producers of covered materials financially responsible for their ultimate disposal. Certain states are also requiring the reduction of plastic or non-recyclable plastic used in these materials over time. Legislation is in various stages of implementation, and Oregon is the first state to issue fees to producers. In connection with a legal challenge to Oregon’s EPR program, a court recently granted a preliminary injunction, preventing Oregon from enforcing the law against the plaintiff (an industry group) pending resolution of the case. Meanwhile, CalRecycle continues to struggle with finalizing its proposed regulations implementing California’s EPR law, this time withdrawing its proposed regulations to tinker with provisions related to food and agricultural commodities.