What you need to know about the Bipartisan MAPS Act
In the age of continuous disruption, from pandemics to geopolitical conflicts and trade uncertainty, the industry’s reliance on fragile, foreign-dependent supply chains has become a national risk that even a highly divided Congress has recognized.
The bipartisan Mapping America’s Pharmaceutical Supply (MAPS) Act reflects a long overdue shift in federal posture: supply chain transparency is no longer aspirational—it’s required.
The MAPS Act (S.1784, 119th Congress) mandates the creation of a national database through the following provision:
The Secretary of Health and Human Services shall establish and maintain a database that maps the supply chains of essential medicines, including the location of manufacturing facilities, the entities that manufacture such medicines, and any vulnerabilities associated with such supply chains, including risks related to overreliance on foreign sources, cybersecurity threats, and potential disruptions due to natural disasters or geopolitical events.”
Axendia began highlighting these vulnerabilities as early as 2008 in our analysis of the Heparin crisis, and expanded on them in Achieving Global Supply Chain Visibility, Control & Collaboration in Life Sciences (2010). Our research, informed by insights from leading Life Sciences executives, predicted the systemic risks Congress now seeks to address. We wrote then:
“Visibility, control, and collaboration across the supply network are no longer operational conveniences—they are regulatory necessities and strategic imperatives.” Senate Testimony References Findings from Axendia’s Global Supply Chain Research
From Thought Leadership to Federal Policy
Axendia’s contributions have shaped strategic thinking on supply resilience for decades. Key findings from our research include:
| Risk Exposure | Industry Insights |
| Active ingredients sourced abroad | 94% of respondents saw this as a key vulnerability |
| Reliance on China and India | 70% and 60% named as critical supply dependencies |
| Lack of supplier transparency | Only 3% had real-time access to data |
| Threats of diversion and counterfeiting | Cited by 35–44% of leaders surveyed |
These weren’t speculative risks—they were structural weaknesses revealed through real-world data. Our guidance was reinforced at the USP Workshop on Supply Chain Integrity, where stakeholders discussed serialization, coordinated inspections, and digital traceability as foundational practices for safeguarding supply chains.
Years earlier, we cautioned that globalization was straining FDA’s traditional oversight model. Our 2010 post called for sponsor accountability and remote collaboration to close inspection gaps, long before pandemic-era challenges made this reality inescapable: Globalization is Straining FDA’s Traditional Oversight Model
The MAPS Act is a legislative response, informed by these historical insights. But visibility alone doesn’t confer resilience. It simply illuminates what must be managed.
What the MAPS Act Does
MAPS calls for targeted funding and tax incentives to boost U.S. manufacturing of APIs, drug products, and excipients. Key actions include:
- Grants and tax credits for domestic manufacturers
The MAPS Act proposes financial support, such as grants and tax credits, specifically aimed at encouraging domestic companies to produce active pharmaceutical ingredients (APIs), finished drug products, and excipients within the United States. These incentives are designed to make local manufacturing more competitive with overseas production and help reduce dependency on foreign supply chains.
- Public-private R&D partnerships for new formulations and sustainable production
The act encourages collaboration between government agencies and private industry to advance research and development in pharmaceutical manufacturing. This includes supporting innovation in drug formulation, process improvements, and adoption of environmentally sustainable practices, ensuring that U.S.-made pharmaceuticals remain at the forefront of technology and efficiency.
- National mapping to identify and address supply risks
In line with the MAPS Act, federal agencies would conduct comprehensive assessments of the domestic pharmaceutical supply chain to pinpoint vulnerabilities, such as overreliance on single sources or geographic regions for critical drugs or raw materials. This mapping initiative aims to inform future investments and policy decisions to strengthen national preparedness and resilience.
- Transparent reporting for safety, traceability, and regulatory oversight
The legislation emphasizes robust requirements for public disclosure and recordkeeping by manufacturers, enhancing the ability of regulatory bodies like the FDA to monitor the safety, origin, and quality of pharmaceutical products. Improved transparency would also facilitate rapid response to recalls, shortages, or threats to drug integrity and supply.
A Strategic Shift to Smart Shoring
Axendia first introduced the concept of smart sourcing in 2010 as a response to the growing risks of globalization, outsourcing, and single-sourcing in Life Sciences. Our research revealed that while these practices offered short-term cost advantages, they introduced long-term vulnerabilities—especially in the face of Black Swan events like pandemics, geopolitical unrest, and natural disasters.
In our 2020 article, Reinventing the Value Network with the Factory of the Future, we urged Life Sciences organizations to shift from rigid supply chains to integrated value networks built on transparency, flexibility, and shared data. We emphasized that smart sourcing must evaluate total value and risk exposure, not just initial cost. That message has only grown more urgent.
Today, we call this evolved strategy smart shoring—a deliberate approach to regionalizing production and sourcing based on resilience, digital maturity, and regulatory alignment. Smart shoring is not about reshoring everything. It’s about making strategic decisions that balance proximity to markets, geopolitical risk, and ecosystem readiness.
As outlined in our 2024 post, 4 Years Ago We Entered the Age of Continuous Disruption, smart shoring supports:
- Redundancy without excess: Multiple qualified suppliers across regions
- Data-rich collaboration: Suppliers share actionable insights—not just certificates of analysis
- Digital traceability: Full visibility across packaging, distribution, and outsourced operations
- Simulation and modeling: Ability to stress-test networks and proactively manage disruption
Organizations embracing smart shoring are better equipped to respond to FDA’s remote oversight expectations, accelerate tech transfer, and maintain continuity during global shocks.
To operationalize smart shoring, Axendia recommends:
- Mapping supplier capabilities by region, including digital readiness and regulatory history
- Establishing feedback loops that enable real-time process optimization across CMOs and internal sites
- Creating commercial and legal frameworks that incentivize transparency and performance
- Using predictive analytics to simulate disruption scenarios and guide sourcing decisions
As we noted in The Life-Science Factory of the Future, “The ability to leverage smart sourced supply networks allows Life Sciences manufacturers to build resilience proactively, instead of reacting to shortages after they happen.”
Smart shoring is not just a sourcing strategy—it’s a resilience blueprint.
Actionable Steps for Life Sciences Leaders can Take
To move from compliance to resilience, Axendia recommends:
1. Mapping Your Network Beyond Tier 1: Uncover dependencies on sole-sourced Tier 2 and Tier 3 suppliers, especially for active ingredients and critical components. 73% of risk exposure resides outside direct supplier relationships.
2. Digitally Transforming Oversight Practices: Implement platforms that support continuous monitoring. Paper-based audits are insufficient and non-scalable. Why Paper Won’t Cut It in FDA’s Remote Oversight Era
3. Building a Smart Shoring Strategy: Use strategic modeling—not cost-based heuristics—to evaluate production relocation. Include geopolitical risks, market proximity, and digital infrastructure.
4. Simulating Disruptions Before They Occur: Stress-test your network with digital twins and predictive modeling to understand failure points and recovery options.
5. Strengthening Partner Collaboration: Shift from oversight to partnership. Incentivize transparency and shared risk management. Are Suppliers and Contract Organizations Putting Your Product’s Quality at Risk?
In Brief
The MAPS Act represents progress. But true resilience demands action from every node of the value network. Visibility is the first step. Digitization, diversification, and collaboration complete the journey.
MAPS provides the policy infrastructure for smart shoring to take root. It shifts incentives from lowest-cost procurement to highest-value resilience, rewarding companies that build domestic networks with high traceability and strategic redundancy.
It’s a long-awaited opportunity to align industry readiness with regulatory modernization.
Life Sciences organizations that embrace these capabilities will be better prepared to deal with the next disruption, as well as safeguard public health and comply with evolving mandates.
How Can We Help?
To navigate uncertainty and build resilience, pharmaceutical and medical device companies can gain valuable insights by engaging with Axendia industry experts. Our analyst team brings deep expertise in business trends, regulatory developments, and technology strategies, offering valuable insights to help Life Science companies optimize operations and drive long-term success.
Engage with Axendia to gain the tools and knowledge your organization needs to thrive in the Age of Continuous Disruption.
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To discuss how this initiative impacts your organization. Click on this link to schedule an Analyst Inquiry on this topic.
Related Content- Explore foundational and current insights from Axendia and strategic collaborators:
- Continuous Innovation and Improvement – The Cornerstone for Resilience
- Optimizing Outcomes Across the Pharma Value Chain Network Featuring Axendia
- Senate Testimony References Findings from Axendia’s Global Supply Chain Research
- USP Workshop on Best Practices to Help Ensure Supply Chain Integrity
- Globalization is Straining FDA’s Traditional Oversight Model
- Pfizer–FDA Collaboration on Supply Chain Security
- Why Paper Won’t Cut It in FDA’s Remote Oversight Era
- Are Suppliers and Contract Organizations Putting Your Product’s Quality at Risk?
The opinions and analysis expressed in this post reflect the judgment of Axendia at the time of publication and are subject to change without notice. Information contained in this post is current as of publication date. Information cited is not warranted by Axendia but has been obtained through a valid research methodology. This post is not intended to endorse any company or product and should not be attributed as such.