"Tucked inside a 3,000-page national defense bill signed into law last month is a set of new regulations that could upend the way some California biotech companies do business. The Biosecure Act, as it is known, is focused on what it describes as "biotechnology companies of concern," or BCCs. The legislation, contained within the National Defense Authorization Act, specifically bars biotech entities that receive federal dollars from working with companies connected to foreign adversaries - namely China, but also Russia, North Korea and Iran."
"The bill will force most biotech firms to re-evaluate their relationships with foreign companies of concern - or hope for a federal waiver, say lawyers and biotech compliance experts. "This will impact the entire pipeline," said Matt McLoughlin, senior vice president of compliance and categories at Scientist.com. Working from his Solana Beach office, McLoughlin advises more than 140 biopharmaceutical companies, including pharma giants with local offices like Sanofi, Novartis, and Pfizer - all of which could be affected by the legislation."
Federal legislation called the Biosecure Act prohibits biotechnology entities that receive federal funding from doing business with companies connected to foreign adversaries, specifically China, Russia, North Korea and Iran. The measure will force most biotech firms to re-evaluate relationships with foreign suppliers or pursue federal waivers. Compliance and procurement teams will need to audit thousands of contracts and supplier links across globally distributed supply chains. Established pharmaceutical firms and smaller biotech companies alike face potential operational disruption. The Office of Management and Budget must publish a list of Biotechnology Companies of Concern by December 2026, delaying final determinations until then.
Read at The Mercury News
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