John Crowley, President and CEO of the Biotechnology Innovation Organization (BIO), released the following statement regarding the resignation of Peter Marks from the FDA: “Under the extraordinary leadership of Dr. Peter Marks, the FDA shepherded in a new era of scientific breakthroughs -- from new vaccines to curative cell and gene therapies that have strengthened and saved the lives of millions of patients and families. “The U.S. has long been recognized as the world leader in medical and scientific innovation and regulation, grounded in transparency and scientific rigor. We are deeply concerned that the loss of experienced leadership at the FDA will erode scientific standards and broadly impact the development of new, transformative therapies to fight diseases for the American people. “It is imperative that we retain and recruit scientific expertise and strong leadership at our health agencies and that the high standards that are the hallmark of these health institutions are upheld and advanced. We are committed to working with the new Commissioner and the Administration to support and enable a strengthened and modernized FDA.”

WASHINGTON (March 26, 2025) -- Today, the Biotechnology Innovation Organization (BIO) released results from a membership survey that underscores the significant, global integration of the biomedical supply chain. According to the findings, nearly 90% of U.S. biotech companies rely on imported components for at least half of their FDA-approved products -- making the supply of medicines for US patients and families especially vulnerable to proposed tariffs on the European Union, China, and Canada. According to the survey, tariffs will:Reduce Access to Affordable Medicines: A staggering 94% of biotech firms anticipate surging manufacturing costs if tariffs are placed on imports from the European Union.Stall Medical Innovation: Proposed tariffs on the EU would force 50% of companies to scramble for new research and manufacturing partners. Half of those surveyed say they would have to rework or potentially delay regulatory filings, jeopardizing the pace of innovation.Create Red Tape: In the face of sudden tariffs, 80% of biotech firms report needing at least 12 months to find alternative suppliers, and a remarkable 44% would require more than two years -- delays that could disrupt the pipeline of breakthrough treatments."This survey demonstrates the far reaching and potentially damaging impacts of the proposed tariffs on our biotechnology industry, on biomedical research and on patients,” said BIO President and CEO John F. Crowley. “We fully support strong policies and programs that incentivize the manufacture of medicines here in America. Re-onshoring key parts of the biotechnology supply chain to the U.S. and our allies and strengthening the American manufacturing base should be a high priority for both national and economic security. It will take years, though, for this shift and we need to be mindful of the negative consequences of these proposed tariffs. We look forward to working with the Administration and Congress to develop incentives and policies that…

WASHINGTON D.C. – Today, the Biotechnology Innovation Organization (BIO), in partnership with Kearney, a global management consulting firm, released a first-of-its-kind report that assesses the significant economic impact of the U.S. bioeconomy, in the context of plant, animal, and biobased products. The report – “Projected Impact and Growth of a Fully Unleashed Bioeconomy: The Value of Food, Agriculture, and Manufacturing Biotechnology” – highlights how this rapidly expanding sector, built on renewable biological resources, is driving continued economic growth, creating hundreds of thousands of new jobs, and fostering sustainable innovation."The power of biotechnology in food, agriculture, and manufacturing plays a pivotal role in fostering long-term economic growth and enhancing our national security," said John Crowley, President and CEO of BIO. "The U.S. must now take a series of bold measures to modernize the regulatory frameworks that govern the review and approval process of new biotechnologies to ensure that our nation continues to lead the world in agricultural innovation.”“For the first time, we have a comprehensive, data-driven analysis that quantifies the economic impact of this critical segment of the bioeconomy,” said Sylvia Wulf, Interim Head of BIO’s Agriculture and Environment Center of Excellence. “This report highlights the immense economic contributions of plant, animal, and biobased product innovations. These insights underline the urgency of public policies and investments that will unlock the bioeconomy’s full potential.” Key findings from the report include:The U.S. bioeconomy contributes ~$210 billion in direct economic impact (excluding healthcare), with indirect benefits pushing the total impact beyond $830 billion.The sector supports 430,000 jobs across various industries.By 2030, plant and animal biotechnology is projected to contribute $56 billion to the U.S. economy.Biobased…