Updated BIOSECURE Act Language Released; House Committee Action Expected Next Week

The end of a busy week brings a new draft BIOSECURE Act—which takes into consideration BIO’s survey findings—and a plan to coordinate and streamline federal regulation of plants, animals, and microorganisms modified through biotechnology. (514 words, 2 minutes, 34 seconds)

BIO congratulates Congress on new draft BIOSECURE Act

BIO President & CEO John F. Crowley congratulated Congress on the new draft BIOSECURE Act, which takes into consideration BIO’s recent survey findings.

The context:BIO reported the results of a survey of 124 biopharma companies, finding that 79% have at least one contract or product with a China-based or China-owned CDMO/CMO, and they’ll need up to eight years to switch manufacturing partners.

The news: House lawmakers yesterday unveiled a new draft of the BIOSECURE Act, which would decouple U.S. biotech’s reliance on China. BIO President & CEO John F. Crowley released a statement commending Congress on the work.

Why it matters: The new BIOSECURE legislation “highlights a key vulnerability in our global supply chain and importantly provides a reasonable timeframe for companies to decouple their reliance on China-based biomanufacturing. It ensures during this transition that important biomedical research will not be slowed and that patients will have unimpeded access to life-saving medicines,” says Crowley.

“BIO applauds this work and supports this BIOSECURE legislation. On behalf of our member companies and the patients we represent and serve, BIO thanks the bill sponsors and the Committees for taking into consideration the findings of our recently released survey on key elements of the global supply chain,” he continues.

“We will continue work with lawmakers on future policies that promote the U.S. as the global leader in biotechnology and as the medicine chest of the world. We look forward to advancing the extraordinary and coordinated policies and programs necessary to redomicile all key parts of the global biopharmaceutical supply chain here in the U.S. for the benefit of the American public and for the entire world,” concludes Crowley.

What’s next: The House Oversight and Accountability Committee is expected to mark up the bill on May 15. 

Read BIO’s full statement.

EPA, FDA, USDA take next step to improve biotech regulation

Several government agencies released a joint plan to coordinate and streamline federal regulation of plants, animals, and microorganisms modified through biotechnology—and BIO is happy to see it.

The plan, promised in President Biden’s September 2022 Executive Order, envisions coordination of the Environmental Protection Agency (EPA), Food and Drug Administration (FDA), and U.S. Department of Agriculture (USDA)—“identifying guidance and regulations to update, streamline, or clarify, and identifying the potential need for new guidance or regulations,” USDA says.

“This report is not itself guidance, but it does lay out lots of opportunity for the agencies to develop new guidance,” explains Leah Buchman, Ph.D., BIO’s Senior Manager of Agriculture & Environment Regulatory Policy. It also enables industry engagement with regulatory improvements.

The plan promises improvements—like developing a commercialization pathway for genetically modified microorganisms, which BIO supports. It now takes an average of 16.5 years to bring a novel trait to market, and more than half the cost of trait development and commercialization is attributed to the regulatory process, according to an AgbioInvestor report.

The big picture: “A lot of these microorganisms can help mitigate problems brought on by climate change,” Buchman explains, “so we need to get these microorganisms in the hands of” farmers.

BIO’s view: BIO is pleased to see the report and looks forward to reviewing the details and analyzing its impact on the industry, says BIO’s statement.

President Biden’s Friday: Attending two fundraisers in the San Francisco Bay area and another in Seattle, per CBS News.

What’s Happening on Capitol Hill: Enjoy the weekend after a busy week.