Yellowhammer Times

U.S. Senator Tommy Tuberville (R-AL) participated in a Senate Health, Education, Labor, and Pensions (HELP) Committee hearing focused on the future of biotechnology in the United States. He spoke with Lowell Schiller, Nonresident Senior Scholar at the USC Schaeffer Institute; John Crowley, President and CEO of Biotechnology Innovation Organization; and Josh Makower, Yock Family Professor of Medicine and of Bioengineering at Stanford University.

During the hearing, Tuberville asked Schiller about how the Food and Drug Administration's (FDA) pre-check program—launched after President Trump’s Domestic Manufacturing Executive Order—could be used to support U.S. drug manufacturing. "Good morning. Mr. Schiller, following President Trump’s Domestic Manufacturing Executive Order that FDA launched—the pre-check program to support U.S. drug manufacturing—the program offers more frequent communication at key development stages and simplifies some manufacturing information required in applications. How can the FDA use pre-check to improve inspections, encourage more domestic pharmaceutical manufacturing?" Tuberville asked.

Schiller responded: "Thank you for the question, Coach. The program has a lot of potential. Some of the challenges around investment in domestic manufacturing goes to a degree of uncertainty about how FDA’s regulations will apply to those facilities. And so having earlier more frequent interactions with the agency through that process can help enormously. There’s other things that the Agency can be doing as well, things like updating manufacturing regulations to accommodate more advanced manufacturing techniques. The regulations were written for conventional older techniques, so updating them to take into account use of AI, use of continuous manufacturing would be incredibly helpful."

Tuberville also highlighted Alabama's Hudson Alpha Institute for Biotechnology as an example of successful innovation in genomics and precision medicine research, noting its economic impact on the state through job creation and research funding attraction.

He asked Crowley what institutes like Hudson Alpha are doing right and how similar efforts could be encouraged nationwide: "Mr. Crowley, [the] Hudson Alpha Institute in Biotechnology in my state of Huntsville is a global leader in genomics... What are the institutes like Hudson Alpha doing right and how can we continue to encourage more similar efforts?"

Crowley replied: "Senator, Coach, thank you for the question... If you look last year, nearly three quarters of all medicines approved by the FDA came [and] originated from startup biotech companies... When we look at what it takes to make newer and better medicines, it’s an entire ecosystem... It takes this community to small companies... providers of capital... I commend the state of Alabama and what they’re doing to promote research, science, and development. This is the heart and soul of biotechnology, and it’s what we need to strengthen and continue."

Tuberville then addressed Makower regarding strategies for maintaining U.S leadership in biotechnology: "Could you explain how America built and sustained this dominance? And what targeted strategies we can pursue to maintain it?"

Makower said: “Absolutely. Thank you for the question, Senator. Most importantly, we need to remove unnecessary delays. Efficiency through the process is absolutely key as most of these innovations are coming as John Crowley mentioned from small companies... So by improving the process and shortening it... that’s one of the primary ways we can do that.”

Senator Tuberville serves on several Senate committees including Armed Services; Agriculture; Veterans’ Affairs; HELP; and Aging.