HB1405 directs the Comptroller General to conduct a study identifying the key regulatory barriers that impede the expansion or siting of new pharmaceutical manufacturing facilities in the United States. The study must assess these barriers on a time-and-cost basis and compare U.S. constraints with those abroad.
It also asks whether environmental and other regulations delay or raise costs relative to other countries and what regulator actions could address these barriers. In addition, the bill requires engaging stakeholders to identify potential technological solutions and supporting policies.
A final report is due within one year of enactment, including findings, analysis, and recommendations to streamline regulatory barriers and to facilitate technology-driven solutions to boost domestic pharmaceutical production.
At a Glance
What It Does
The Comptroller General must conduct a time-and-cost based study to identify regulatory barriers hindering expansion or siting of pharmaceutical facilities in the United States, and to assess what actions regulators could take and what tech solutions could help.
Who It Affects
Pharmaceutical manufacturers seeking to expand or site new facilities; environmental and regulatory agencies that oversee reviews; supply-chain stakeholders and policymakers; state and local economic development offices.
Why It Matters
The study aims to illuminate how regulatory regimes affect competitiveness and resiliency of the U.S. drug supply, informing potential policy changes and modernization efforts.
More articles like this one.
A weekly email with all the latest developments on this topic.
What This Bill Actually Does
The bill assigns a clear, data-driven mandate to the Comptroller General (GAO) to map out the regulatory landscape that shapes where and how new pharmaceutical manufacturing plants can be built in the United States. It asks for a rigorous assessment of the key barriers that slow expansion or siting, including environmental and other regulations that might increase time and cost relative to peer nations.
The GAO must consider how these barriers impact the resilience of the pharmaceutical supply chain and what regulator actions could help—such as faster reviews or inspections—and what technology-enabled solutions might address the barriers. The process requires broad engagement with stakeholders to identify barriers, plausible tech solutions, and the policies needed to support those solutions.
The result will be a report due within one year, detailing barriers, answering the prescribed questions, and offering concrete recommendations to streamline regulations and promote domestic manufacturing. This is a study, not a regulation, but its findings could influence future policy and practice to strengthen the U.S. drug supply.
The Five Things You Need to Know
The Comptroller General must identify and assess regulatory barriers that impede expansion or siting of U.S. pharmaceutical facilities on a time-and-cost basis.
The bill requires comparing U.S. regulatory barriers to those in other countries to gauge competitiveness.
It directs stakeholder engagement to surface barriers, technology solutions, and policy needs.
A comprehensive report is due within one year of enactment detailing barriers, questions, and recommendations.
The act designates the Enhancing Domestic Drug Manufacturing Competitiveness Act as the short title for citation purposes.
Section-by-Section Breakdown
Every bill we cover gets an analysis of its key sections.
Short Title and citation
Section 1 provides the act’s short title, the Enhancing Domestic Drug Manufacturing Competitiveness Act, establishing how the bill may be cited in law and discourse. This designation enables clear reference in future legislative and policy work.
Study scope and purpose
Section 2(a) directs the Comptroller General to conduct a study to identify and assess the key regulatory barriers that impede the expansion or siting of new pharmaceutical manufacturing facilities in the United States. The assessment should be time- and cost-based, creating a baseline for comparing regulatory burdens against other countries and for informing potential policy responses.
Regulatory questions considered
Section 2(b) requires the study to consider specific questions about how environmental and other regulations delay or increase costs for expanding or siting facilities, and how these costs compare with those in other jurisdictions. It also asks what impact such regulations may have on pharmaceutical supply chain resiliency and what actions regulators could take to address identified barriers, including expedited reviews or changes to inspection and approval practices.
Stakeholder engagement
Section 2(c) tasks the Comptroller General with engaging stakeholders to identify barriers, assess promising technology-enabled manufacturing solutions, and determine the policies needed to support those solutions. This engagement ensures the study reflects practical realities from industry, regulators, and other affected actors.
Reporting and contents
Section 2(d) requires a final report within one year of enactment. The report must identify and assess regulatory barriers, address each listed question, and offer recommendations for streamlining barriers and facilitating technological solutions to foster increased domestic pharmaceutical manufacturing.
This bill is one of many.
Codify tracks hundreds of bills on Economy across all five countries.
Explore Economy in Codify Search →Who Benefits and Who Bears the Cost
Every bill creates winners and losers. Here's who stands to gain and who bears the cost.
Who Benefits
- Pharmaceutical manufacturers planning expansion or siting of new facilities in the United States, who gain clearer insight into regulatory hurdles and potential paths to compliance.
- US healthcare supply chain stakeholders, including hospitals and distributors, who stand to benefit from a more resilient drug supply resulting from clearer regulatory regimes.
- Federal agencies responsible for environmental and regulatory reviews, which receive data and analysis to inform future policy changes.
- State and local economic development offices that compete to attract pharmaceutical investment and jobs by understanding regulatory timelines.
- Policy makers and industry associations that will use the findings to shape reforms and incentives.
Who Bears the Cost
- GAO staff and contracting resources to conduct the study.
- Federal agencies and regulatory bodies that participate in data collection, analyses, and potential process changes identified by the study.
- State and local authorities that may need to adjust permitting workflows if streamlined procedures are recommended.
- Pharmaceutical firms may incur up-front costs to align with any new streamlined processes or data requests arising from the study’s recommendations.
- Public sector entities could face implementation costs if policy changes result from the study’s recommendations.
Key Issues
The Core Tension
The central tension is between accelerating domestic drug manufacturing through streamlined processes and preserving environmental, safety, and quality safeguards that govern site selection, permitting, and operation of pharmaceutical facilities. The bill contemplates recommendations that could ease barriers, but doing so must balance rapid development with robust protections and equity considerations across jurisdictions.
The bill directs a government-wide, data-driven inquiry into regulatory barriers, without prescribing immediate regulatory changes. While the aim is to improve competitiveness and resilience of domestic drug manufacturing, the study will depend on access to regulatory data and interagency cooperation.
Implementation of any recommendations would require careful consideration of environmental safeguards, worker safety, and existing statutory authorities. The exercise could reveal tensions between the speed of reviews and the maintenance of stringent standards, and it may identify financial or logistical hurdles to adopting new manufacturing technologies.
Smart execution will require alignment across federal agencies, industry participants, and state/local authorities to ensure findings translate into practical, scalable changes.
Try it yourself.
Ask a question in plain English, or pick a topic below. Results in seconds.