WASHINGTON, DC, April 8, 2025 – Today, the National Security Commission on Emerging Biotechnology (NSCEB), a bipartisan legislative commission established by Congress, issued its much-anticipated report detailing how the United States risks losing its position as the global leader in biotechnology and what must be done to maintain and advance our lead in this critical field. In response, John F. Crowley, President and CEO of the Biotechnology Innovation Organization (BIO), issued the following statement:“The United States has been the global leader in biotechnology since the creation of this industry nearly 50 years ago, with innovative advances and breakthrough therapies that touch nearly every aspect of our lives. A strong and vibrant biotechnology industry is vitally important to public health, our economic strength and our national security.“But today, U.S. dominance in biotechnology is under great threat and our industry is at a crossroads. The NSCEB final report makes clear that without immediate and bold action, the U.S. will cede its dominance in biotech to China in the next few years. This cannot happen.“The report provides us with a roadmap to unlock private investment in biotechnology and protect the health and security of the American people for generations to come.“Working together, the U.S. government, academia and the private sector have the power to ensure that American biotech out-innovates the competition, grows our economy, and speeds progress that transforms scientific discoveries into real-world products and solutions.“BIO thanks the Commission for its tireless work in bringing these findings to light and underscoring what is at stake for the future of American biotechnology. We look forward to working with Congress and the Administration to advance and implement policies that will protect and advance America’s biotech leadership.”The full report, including the Commission’s comprehensive set of recommendations can be found on the…

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…