The Mapping America’s Pharmaceutical Supply Act mandates the comprehensive assessment and mapping of the U.S. supply chain for essential medicines to identify and mitigate national security and public health risks.
Doris Matsui
Representative
CA-7
The Mapping America’s Pharmaceutical Supply Act (MAPS Act) mandates the expansion and regular review of the Essential Medicines List to include drugs critical for national security threats. The bill requires comprehensive risk assessments and mapping of the supply chains for these essential medicines to identify vulnerabilities in sourcing raw materials and manufacturing. Finally, the Secretary of Health and Human Services must report annually to Congress on supply chain mapping progress, identified risks, and efforts to strengthen domestic production capabilities.
The newly proposed Mapping America’s Pharmaceutical Supply Act (MAPS Act) is essentially the federal government finally deciding to get a detailed GPS for the drugs we rely on every day. Its main goal is simple: figure out where our essential medicines come from, who makes them, and where the weak spots are so we don't end up scrambling during the next crisis.
Right now, the government keeps an Essential Medicines List, which covers drugs critical for basic healthcare. Section 2 of the MAPS Act expands this list significantly. The Secretary of Health and Human Services (HHS) now has to update it to include drugs and active ingredients necessary for responding to chemical, biological, radiological, or nuclear threats. Think of it as adding emergency supplies to the regular pantry list. This list must be reviewed and updated at least once every two years, with the first update due within 180 days of the law passing. For the average person, this means the government is proactively trying to secure access to a wider range of critical medications, not just the ones needed for chronic conditions, but also those needed if a major disaster hits.
This is where the bill gets down to business. Section 3 mandates a comprehensive risk assessment of the entire supply chain for every drug on that expanded Essential Medicines List. HHS must identify any essential drug where more than 50% of its production relies on a foreign supplier. They also have to flag drugs that come from a single source—domestic or foreign—especially if the active ingredients are single-sourced. The assessment must also look at our current ability to manufacture these drugs cost-effectively in the U.S. and detail any national security dangers, including cybersecurity threats, tied to these supply chains.
This is a massive undertaking. For pharmaceutical companies, it means the government is going to be digging deep into their production data. For consumers, it’s a necessary step toward understanding why certain generic drugs disappear during a pandemic or international trade dispute. If the assessment finds we rely on one factory overseas for a critical heart medication, the government is then required to outline how it plans to fix that risk, possibly using powers like the Defense Production Act of 1950 to spur domestic production.
Section 4 requires HHS to literally map out the entire supply chain, from the raw starting materials and non-active ingredients (excipients) all the way through to the final distribution. To do this, the Secretary needs to collect specific, sensitive data, including the exact locations and production amounts of facilities making active ingredients and final drugs. They also need to share regulatory actions—like inspection failures or recalls—between federal agencies.
This increased data sharing is a key point. While Section 6 assures manufacturers that sharing this sensitive business information between agencies won't automatically waive protections under trade secret laws or the Freedom of Information Act (FOIA), it does grant HHS significant new authority to collect and share proprietary data internally. While this is crucial for spotting vulnerabilities—say, if a single overseas plant is hit by a natural disaster or a cyberattack—it also means private companies will be handing over highly competitive information to the government. The Secretary is required to put strong cybersecurity measures in place to protect this data, which is a necessary safeguard given the sensitivity of the information being exchanged.
In short, the MAPS Act is an attempt to inject transparency and security into the pharmaceutical pipeline. It’s the government saying, 'We can't afford to be surprised by drug shortages anymore.' While it creates a lot of new reporting and data requirements for both federal agencies and the drug industry, its aim is to make sure that when you or a family member needs a critical medicine, it’s actually available, regardless of what’s happening halfway around the world.