The U.S. Department of the Treasury is preparing to issue a proposed rule that would subject outbound licensing deals between U.S. companies and Chinese biotech firms to additional regulatory scrutiny. Endpoints News reports the action could occur as early as tomorrow, marking a significant expansion of federal oversight into the pharmaceutical sector's international financial arrangements.
This move falls under the Comprehensive Outbound Investment National Security Act, known as the COINS Act. Enacted in December 2015, the legislation currently places specific American investments in Chinese technology under Treasury screening. The proposed rule would extend this framework to include biotechnology transactions, reflecting broader government concerns regarding national security and technology transfer.
Rob Smith, an analyst at Capital Alpha Partners, wrote to investors that the pharmaceutical industry faces significant hurdles in overcoming objections to this regulatory shift. Smith noted that pervasive anti-pharma views within many parts of Congress and the current administration, combined with general concerns about China’s ambitions, create a difficult environment for industry advocacy.
Separately, telehealth companies are increasingly marketing off-label prescriptions of GLP-1 drugs for the treatment of alcohol use disorder and other addictions. STAT reports that these businesses are responding to what addiction medicine experts describe as a significant unmet medical need. GLP-1 drugs, widely known for weight loss and diabetes management, are being prescribed by some platforms for conditions they are not formally approved to treat.
As early evidence of these drugs' potential benefits emerges and personal stories circulate on social media, some patients have explicitly sought out these prescriptions to reduce their drinking. However, experts raise concerns about the fragmented nature of care and the risk of potentially inappropriate prescriptions. Researchers are still working to understand and vet these unproven treatments, leaving the long-term safety and efficacy of this off-label use unclear.