
Bright Path Applauds President's FY2027 Budget for Investing in Domestic Pharmaceutical Manufacturing
Proposed funding at ASPR and FDA would accelerate advanced manufacturing technologies and strengthen America's ability to produce its own essential medicines
MESA, Ariz., April 14, 2026 /PRNewswire/ -- Bright Path, a U.S.-based advanced pharmaceutical manufacturer, today applauded the President's Fiscal Year 2027 budget proposal for its significant investments in advanced manufacturing technologies as a pathway to domestic production of essential medicines. The proposed budget builds on the momentum of the President's April 2 Section 232 proclamation imposing tariffs on imported pharmaceuticals, creating a comprehensive policy environment that pairs trade enforcement with the federal investment needed to build real manufacturing capacity on American soil.
"What we're seeing from this Administration is a two-part strategy: use trade policy to level the playing field, and then resource the agencies that can help American companies actually deliver," said Bright Path Founder and CEO Tony Quiñones. "That's exactly what these proposed investments would do."
More than 95 percent of generic drugs consumed by the American public come from one or two international sources, creating significant quality and supply chain risks. Drug shortages at U.S. hospitals have reached record levels, affecting essential medicines including chemotherapy drugs, anesthetics, and other treatments that patients cannot go without. While trade enforcement addresses the economic incentives for offshoring, advanced manufacturing technologies offer a solution to the central challenge of bringing production back: making domestic manufacturing cost-competitive with overseas production.
Bright Path's manufacturing platform uses the company's patented Spinning Tube-in-Tube (STT®) continuous flow reactor technology, which the company designs, fabricates, and assembles entirely in-house. The platform produces medicines in less time, at lower cost, and at higher quality than traditional batch approaches, making domestic production cost-competitive with manufacturing overseas. The company has filed Abbreviated New Drug Applications (ANDAs) with the FDA for lidocaine and carboplatin, two essential hospital medicines that appear on the FDA drug shortage list.
$325 Million Increase at ASPR for Domestic Manufacturing Infrastructure
The President's FY2027 budget proposes a $325 million increase for the Center for Industrial Base Management and Supply Chain (IBMSC) within the Administration for Strategic Preparedness and Response (ASPR). The funding would allow ASPR to continue its work to reshore and maintain a resilient, reliable U.S.-based pharmaceutical supply chain that ensures essential medicines are available where and when they are needed.
Bright Path has partnered with ASPR through IBMSC and with the Defense Advanced Research Projects Agency (DARPA) through the EQUIP-A-Pharma program, under which the company has achieved all contract milestones across three successive awards. The EQUIP-A-Pharma program was designed to develop deployable pharmaceutical manufacturing capability for the United States, and Bright Path's performance under the program demonstrates that advanced manufacturing technologies can deliver on that mission at scale.
"ASPR and IBMSC understand what it takes to build a domestic pharmaceutical supply chain from the ground up," Quiñones said. "They've been our partners through DARPA, and they've seen what this technology can do. This proposed investment would allow them to build on that progress and bring more advanced manufacturing capacity online across the country."
$9 Million at FDA to Accelerate Advanced Pharmaceutical Manufacturing
The budget also proposes $9 million and 19 new full-time positions at the Food and Drug Administration to accelerate advanced pharmaceutical manufacturing. The funding would support science- and risk-based approaches to streamline Chemistry, Manufacturing, and Controls (CMC) reviews, and would fund FDA PreCheck, a two-phase initiative to accelerate the establishment of new or advanced pharmaceutical manufacturing facilities in the United States.
The current regulatory framework for generic drug approvals was built around traditional batch-based manufacturing, and does not fully accommodate the speed, flexibility, and process advantages achievable through advanced manufacturing technologies such as continuous flow production. While FDA has made important progress through programs like the Emerging Technology Program, in which Bright Path is an active participant, additional investment is needed by the agency to further develop regulatory models that keep pace with the technology.
To ensure these initiatives have a clear path forward, Bright Path encourages FDA to modernize approval pathways for continuous manufacturing, including merging the advanced review concepts already applied to New Drug Applications (NDAs) with the Abbreviated New Drug Application (ANDA) review process. Doing so would help ensure that the regulatory framework supports, rather than delays, the domestic manufacturing capacity that both the tariffs and these proposed investments are designed to create.
"The technology is ready. The agencies need the resources to keep pace with it," Quiñones said. "We encourage Congress to follow the President's lead and make these funds available. Every month that passes without adequate investment in advanced manufacturing and modernized regulatory pathways is another month that American patients remain dependent on foreign supply chains for medicines they cannot go without."
About Bright Path
Bright Path's manufacturing platform uses the company's patented Spinning Tube-in-Tube (STT®) continuous flow reactor technology, which the company designs, fabricates, and assembles entirely in-house. Bright Path is a direct recipient and partner of the Defense Advanced Research Projects Agency (DARPA), which selected the company for its EQUIP-A-Pharma program to advance domestic pharmaceutical manufacturing capability. The platform has been validated through that program, under which Bright Path has achieved all contract milestones across three successive awards. The company has filed Abbreviated New Drug Applications (ANDAs) with the FDA for lidocaine and carboplatin, two essential hospital medicines that appear on the FDA drug shortage list.
Contact: Bruce Fryer, [email protected]
SOURCE Bright Path
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