[{"_1":2,"_123":-5,"_124":-5},"loaderData",{"_3":4,"_26":27},"root",{"_5":6,"_17":10,"_18":19,"_20":21,"_22":10,"_23":-5,"_24":-5,"_25":10},"user",{"_7":8,"_9":10,"_11":10,"_12":-5,"_13":-5,"_14":15,"_16":-5},"roles",[],"isAuthenticated",false,"isPremium","planName","subscriptionStatus","featureFlags",{},"insightsBudget","isDevelopmentHost","userPreferences",{},"recaptchaSiteKey","6LcvOJcUAAAAAHsB-gPGfGktcRlKpH7OTIU_dMTD","isImpersonating","impersonation","affiliateStatus","isFreedomPortal","routes/v2/article/layout",{"_28":29,"_30":31},"notFound",true,"relatedArticles",[32,75,87,99,111],{"_33":34,"_35":36,"_37":38,"_39":40,"_41":42,"_43":44,"_45":46,"_47":48,"_49":50,"_51":52,"_53":54,"_55":56,"_57":58,"_59":60,"_61":62,"_63":64,"_65":66,"_67":68,"_69":70,"_71":72,"_73":72,"_74":72},"mediaId",6641538,"mediaKeyId","3805113-7696aac7cd902efad140ad99dcbeee74","parentId",3805113,"title","USP: mapping shows upstream concentration of APIs/KSMs; calls for benchmarks and advanced manufacturing support","audioSeconds",176,"startMs",3312000,"endMs",3488000,"viewUrl","/Search/View?dp=1&key=3805113-7696aac7cd902efad140ad99dcbeee74&start=3312&end=3488","thumbnailUrl","https://assets.pipeline.soar.com/3805113-7696aac7cd902efad140ad99dcbeee74/thumbnail_3312000.jpg","articleUrl","/articles/6641538/USP-mapping-shows-upstream-concentration-of-APIsKSMs-calls-for-benchmarks-and-advanced-manufacturing-support","mediaUrl","https://secure.pipeline.soar.com/6641538-f8a7b0978032a9c132a9f86ae04ad87b/orig.mp4?Expires=1775128273&Signature=nSqA7hZPSGUe0DOJ2Kg54HlMcTKc0jFJkC72dmyF7NTmV49O5DHxmxtSTcD1cUPW0Ou9eZZCxQb3I8-U56RMPGCupJxgz9~inflQJa2KOLGqdIc7Y95MTmNC83x-3LMcExhyGJXD-17AeQYYvT8UffBKW0u-sB0jXoGq67JfWpDLciTNDcs4IzS2hDh9i9LeeFr9fpXjgvlhej9Ojx6Ecikd0DgJ3I4OdCVw7DjlzcqSSjYKd2oG~eklo7Oke0T7~FISPJEFmY84J4ldlNYhhMxSIziI1ZCo4-iza3glJLSRZAQ6V2Z-wrdbwWhZUu9wNwsjc36gpNKJpWocyUw7DA__&Key-Pair-Id=KUT5TJCACFTXG","author","U.S. House Committee on Energy and Commerce","date","2025-06-12T05:29:34Z","article","The United States Pharmacopeia (USP) told the House Energy and Commerce Subcommittee that its medicine supply map now covers roughly 94% of U.S. drug products and ingredients and shows a high degree of geographic concentration for key starting materials (KSMs) and active pharmaceutical ingredients (APIs).

USP CEO Ronald J. Piervincenzi testified that the map identifies more than 100 vulnerable medicines that are both at high risk for disruption and hard to substitute therapeutically. Using that evidence, USP urged a set of targeted interventions: continuous identification of vulnerable medicines, investment in advanced manufacturing and alternative synthetic pathways for APIs, resiliency benchmarks for purchasers, and greater use of supply‑chain visibility tools.

Why it matters: USP framed the problem as an upstream vulnerability — many APIs and starting materials are produced in a small number of locations — and said that once the source is mapped it becomes possible to develop alternative synthesis routes or invest in domestic/nearshore production at reasonable cost.

Selected testimony excerpts and recommendations:
- \"Over 80% of key ingredients and raw materials used in U.S. medicines are manufactured abroad today,\" Piervincenzi said, and he noted that China’s filings for APIs rose rapidly in recent years.
- USP recommended establishing a resiliency benchmark that purchasers (public and private) could use so that contracts and stockpiles value supply reliability and consistency, not just the lowest price.
- USP urged Congress to fund and support advanced manufacturing and to invest in KSM and API production as parts of a multi‑year strategy to reduce upstream vulnerability.

Ending: USP told the committee the mapping work makes precise where investments are needed and that targeted investments in chemistry and manufacturing can create durable alternatives to current single‑point dependencies.","mediaType","Video","parentTitle","Made in America: Strengthening Domestic Manufacturing and the Health Care Supply Chain","oneSentenceSummary","United States Pharmacopeia told the House subcommittee its medicine‑supply mapping shows geographic concentration of key starting materials and APIs, and recommended a data‑driven approach that includes resiliency benchmarks, expanded supply‑chain visibility and support for advanced manufacturing technologies.","taxTitle","Energy and Commerce: House Committee, Standing Committees - House & Senate, Congressional Hearings Compilation, Legislative, Federal","taxId",1824,"location","","headline","shortSummary",{"_33":76,"_35":36,"_37":38,"_39":77,"_41":78,"_43":79,"_45":80,"_47":81,"_49":82,"_51":83,"_53":84,"_55":56,"_57":58,"_59":85,"_61":62,"_63":64,"_65":86,"_67":68,"_69":70,"_71":72,"_73":72,"_74":72},6641542,"State boards and NABP pilot Pulse to detect counterfeit meds as DSCSA deadlines approach",191,3899000,4090000,"/Search/View?dp=1&key=3805113-7696aac7cd902efad140ad99dcbeee74&start=3899&end=4090","https://assets.pipeline.soar.com/3805113-7696aac7cd902efad140ad99dcbeee74/thumbnail_3899000.jpg","/articles/6641542/State-boards-and-NABP-pilot-Pulse-to-detect-counterfeit-meds-as-DSCSA-deadlines-approach","https://secure.pipeline.soar.com/6641542-f415db1cf3a6f032ad44b472dcf392fc/orig.mp4?Expires=1775128273&Signature=AgEbKwO6CyqoUjYq2o4dUkMntISugVN7HxlipY~kYbWtWAStdflscsCwPkCvLAGdsipvD4~4r5FvIrNhOdIvT3oV1dYJlfnX1pkrYVWryuHqCx1aB7P6YZP0zJhkwg7QQI1cY593SoSUZOmnHss0oRbCLtKHnbUxnKeBBpFWgox3~6OWjmXigdv1pgpG7aZ85bjHSxOFKRbat0EZ0FWzzt4c-2wVnS9KKMOBs1u8jHi9erKoW7UOsmDaTcdsOQqtpb~bR~gBTyJoZ0b80GZVhzmp4~2CiCC0pw0vIuknqicgzWWN5FNvdhl37BBvcLTHCrWkrUFUksei5w3cVs9k9A__&Key-Pair-Id=KUT5TJCACFTXG","The National Association of Boards of Pharmacy told a House subcommittee that new digital tools tied to the Drug Supply Chain Security Act (DSCSA) are beginning to give regulators and trading partners better visibility into the U.S. pharmaceutical supply chain and have already helped identify illegitimate and counterfeit products in the field.

Josh Bolan of NABP described Pulse, a DSCSA‑aligned platform launched in January that acts as a directory of manufacturers, distributors and pharmacies and enables scanning and verification of serialized saleable units. Bolan said that scans conducted with Pulse helped Arkansas and Mississippi boards of pharmacy detect illegitimate GLP‑1 medications that had entered the legitimate supply chain.

Why it matters: the DSCSA requires product serialization and interoperable data sharing to prevent dangerous or counterfeit medicines from reaching patients. Witnesses said longer implementation timelines raise the risk that illicit products will circulate; conversely, broader adoption of DSCSA tools by states and trading partners can help detect and remove bad product and support recalls.

Highlights from testimony:
- Pulse is being offered at no cost to state boards and pharmacies; NABP reported expansion to nearly 30 states and said the platform assisted regulatory action in multiple states.
- Bolan warned about illegal online pharmacies and identified the med‑spa example discussed in testimony where nonsterile compounding and foreign‑sourced APIs were used outside of regulated channels.
- Witnesses told members that while serialization generates massive volumes of data (estimated billions of transactions annually), practical directory tools and regulator access are necessary to make the DSCSA effective in the field.

Ending: Members and witnesses urged faster DSCSA adoption and additional resources for state regulators so the tracing architecture can be used to detect counterfeits and improve supply reliability. The DSCSA phased deadlines remain a near‑term implementation milestone the committee will monitor.","Josh Bolan of the National Association of Boards of Pharmacy described a DSCSA‑compliant digital directory, Pulse, and said early scans using the tool helped identify illegitimate GLP‑1 products. The subcommittee heard that improved electronic tracing and state use of Pulse can reduce counterfeit entries and help manage shortages.",{"_33":88,"_35":36,"_37":38,"_39":89,"_41":90,"_43":91,"_45":92,"_47":93,"_49":94,"_51":95,"_53":96,"_55":56,"_57":58,"_59":97,"_61":62,"_63":64,"_65":98,"_67":68,"_69":70,"_71":72,"_73":72,"_74":72},6641547,"Witnesses warn FDA staffing cuts and slowed inspections would worsen drug shortages and safety risks",2385,2344000,4729000,"/Search/View?dp=1&key=3805113-7696aac7cd902efad140ad99dcbeee74&start=2344&end=4729","https://assets.pipeline.soar.com/3805113-7696aac7cd902efad140ad99dcbeee74/thumbnail_2344000.jpg","/articles/6641547/Witnesses-warn-FDA-staffing-cuts-and-slowed-inspections-would-worsen-drug-shortages-and-safety-risks","https://secure.pipeline.soar.com/6641547-b887fb88c4b837112a439399bcbd8559/orig.mp4?Expires=1775128273&Signature=XDUwBtgKDUKCqRL9CgVvO2F4YxjWLgYGer-LREgm2p6BTZg3oUtVTHAGyHor9E8Wb3DmBVltPRQQCGO2Wb6nBk0W-KuzJdd3HAj1~Op8lSw~XQ2Tf--WTsFTPaylr2mVe53IhV1a15VYhCIeQrrCcrwuhjw3nHn7cDNz5D~OLu0VqWpeYUuGLPR8iwDbv7XTsvhbZYAATyRBaldOxM4VcP2wZZCeFdZB9tyK34bl8n9cyZ~zBW1cAoK47DQnIRrCNkxOdgbvUVq9Nmv3v-PHZ1jRCYgwdx8ll7QlU~bRuzV5kJDwFOSs7spHLkSQJLsDW7lJ9eVkIZlIJH3idH5AZg__&Key-Pair-Id=KUT5TJCACFTXG","Lawmakers and witnesses at a House subcommittee hearing raised alarms about proposed staffing reductions and reorganization at the Food and Drug Administration and said diminished inspection and regulatory capacity would hamper efforts to secure domestic pharmaceutical production and ensure drug quality.

Ranking members and witnesses repeatedly warned that inspection capacity and policy guidance are critical to safe domestic production. Representative Frank Pallone and Representative Diana DeGette highlighted that layoffs and paused work on generic drug guidance would make it harder to address shortages and rebuild domestic manufacturing.

Key testimony and exchanges:
- Representative Pallone said recent firings and reorganization at HHS and FDA “put the health and well‑being of the American people...at extreme risk,” and urged robust oversight of agency actions.
- USP’s Ronald Piervincenzi and the Association for Accessible Medicines’ John Murphy said strong FDA inspections and product‑specific guidances are essential. Murphy noted that delays in releasing product‑specific guidances had already created backlogs and slowdowns in generic development; he welcomed the agency’s steps to resume issuing guidance but said capacity is still needed.
- Witnesses described that reduced inspection capacity could slow approval and restart of domestic lines and overseas inspections, limiting both safety assurance and the ability to rely on reshored production.

Why it matters: FDA inspection and regulatory review are prerequisites to bringing new or retooled domestic facilities into operation. Witnesses said that without stable inspection staffing and timely guidance, manufacturers cannot confidently invest in U.S. production and the risk of poor quality or counterfeit products entering the supply chain rises.

Ending: Witnesses and several members urged Congress to fund FDA inspection capacity and provide the agency with stable resources so inspections and guidance can keep pace with efforts to onshore production and respond to shortages.","Multiple witnesses and members told the House Energy and Commerce subcommittee that proposed agency layoffs and paused guidance work at FDA could delay approvals and inspections, aggravating drug shortages and undermining efforts to reshore production.",{"_33":100,"_35":36,"_37":38,"_39":101,"_41":102,"_43":103,"_45":104,"_47":105,"_49":106,"_51":107,"_53":108,"_55":56,"_57":58,"_59":109,"_61":62,"_63":64,"_65":110,"_67":68,"_69":70,"_71":72,"_73":72,"_74":72},6641552,"Last U.S. amoxicillin maker urges long‑term federal contracts to secure supply",326,2682000,3008000,"/Search/View?dp=1&key=3805113-7696aac7cd902efad140ad99dcbeee74&start=2682&end=3008","https://assets.pipeline.soar.com/3805113-7696aac7cd902efad140ad99dcbeee74/thumbnail_2682000.jpg","/articles/6641552/Last-US-amoxicillin-maker-urges-longterm-federal-contracts-to-secure-supply","https://secure.pipeline.soar.com/6641552-631e4308f8da2e2fd8d253b119e65185/orig.mp4?Expires=1775128273&Signature=Y8hd5XQO~6ATDLJknu19EBTQq-PinaiDUocsZm8LvgVJ3kFDLgOxItlvUSE1h34JIky3ompOIhc3An3v3EkbZt4Hf-m8lypc3xqiYlMGVrOduINktd1OgLAL0I03C10sxjl-UXTR2tk0dBSgcXYIeETPcCi7ySP28bUz02avgwLWvP1H~lVlfjENYILneSn~bYRnY5qgwsHcmkdgdV8rviEuDYXNT-o0Iu-EO2gDCOPpQcL4ph-SkYGImEYp9L66kpzKm102~r0QmOUBi2CFoJipD7Bv0gk69kkEyFkutH46uDlhwEK9McXDw~52M22ROoMRC3g~7YCYkg31TZ~g3g__&Key-Pair-Id=KUT5TJCACFTXG","Patrick Cashman, president of US Antibiotics, told the House Energy and Commerce Subcommittee on Health that his Bristol, Tennessee facility is the last end‑to‑end U.S. maker of amoxicillin and urged federal policy changes to keep that capacity operating.

Cashman said US Antibiotics supplies a product that accounts for roughly 50 million U.S. prescriptions annually and that the company now has about a 5% market share after investors reactivated production. He warned that if the plant were to close permanently it would take “no less than 5 years and hundreds of millions of dollars to construct a new facility capable of producing amoxicillin.”

Why it matters: witnesses and members described amoxicillin as a common but strategically important generic antibiotic; concentrated foreign production of APIs and key starting materials creates a national security and clinical risk if the remaining domestic supplier goes offline.

Key points from Cashman’s testimony and committee questions:
- “Approximately 45% of the global amoxicillin API production capacity is concentrated in China,” Cashman said, and he added that China supplies a significant share of the key starting materials Indian manufacturers use.
- He listed three market challenges for domestic generic manufacturers: (1) unfair foreign subsidies and regulatory differences; (2) lack of long‑term government purchasing commitments that would create stable demand; and (3) lack of recognition of generics as strategic assets that qualify for industrial supports available in other sectors.
- Cashman proposed four policy responses: incentivize multiyear federal purchase agreements; implement Buy‑American preference for antibiotics bought with federal funds when a U.S. manufacturer exists; create a strategic antibiotic manufacturing fund (grants, low‑interest loans and tax incentives); and enforce trade rules against predatory pricing (including use of a Section 232 investigation).

On timing and capacity, Cashman said US Antibiotics operates multiple production lines and could expand production materially within about 18–24 months by adding shifts and restarting idle lines; building a new campus, by contrast, would take years and far larger investment.

Committee exchanges highlighted procurement rules and small‑business set‑asides. Cashman stated he could not bid for a particular Strategic National Stockpile purchase that targeted small businesses because of US Antibiotics’ ownership structure; he asked the committee to weigh procurement policy changes that would favor resilience in addition to price.

Ending: Cashman urged Congress to adopt policies that reward supply reliability alongside cost. He concluded his opening statement: “We have the infrastructure and we have the expertise, but we need this Congress to act.”","Patrick Cashman, president of US Antibiotics, told a House subcommittee that his Bristol, Tennessee plant is the only U.S. end‑to‑end manufacturer of amoxicillin and asked Congress for predictable purchasing, buy‑American rules and a strategic manufacturing fund to prevent future shortages.",{"_33":112,"_35":36,"_37":38,"_39":113,"_41":114,"_43":115,"_45":116,"_47":117,"_49":118,"_51":119,"_53":120,"_55":56,"_57":58,"_59":121,"_61":62,"_63":64,"_65":122,"_67":68,"_69":70,"_71":72,"_73":72,"_74":72},6641556,"House subcommittee hears bipartisan concerns over U.S. dependence on foreign drug supply chains",11415,1469000,12884000,"/Search/View?dp=1&key=3805113-7696aac7cd902efad140ad99dcbeee74&start=1469&end=12884","https://assets.pipeline.soar.com/3805113-7696aac7cd902efad140ad99dcbeee74/thumbnail_1469000.jpg","/articles/6641556/House-subcommittee-hears-bipartisan-concerns-over-US-dependence-on-foreign-drug-supply-chains","https://secure.pipeline.soar.com/6641556-be5fb422292f3de001408eb28876e812/orig.mp4?Expires=1775128273&Signature=kyiUzBLtYsIxGRxaIhSnJXrSrYDGjoho6jZfBMQzUz1ZWxGBEgu4YERCAqI~FAyW4o~bHkqcOtEM-sTbyR5ezJ~LuZkIk5U8XsEiYF5LQ6v1BWWC8kYGRI9CFHMqPFcoY1HBcyQqRLkHPKx6RLzygk2sT5OvZiCoq0vlRy3b6TCvknxGMUuf0RyI~5GCwecpdu-DgptRJ-keHPFt95K8bKMT1HTnNixPTb~mn2dmFOI8vL3xfhbTW4dDKmcL4S-qs94Am-P7G3M3Fz8hFHuMU6bUEN-rKtqvcdDwMMmGkycJsDzEMiF5esFhkSbditIposkJ9t2Ml7Lmu01mlD-Mtg__&Key-Pair-Id=KUT5TJCACFTXG","A House Energy and Commerce Subcommittee on Health hearing on June 25 examined vulnerabilities in the U.S. drug supply chain and possible fixes, with lawmakers and industry witnesses warning that reliance on foreign manufacturers — particularly upstream suppliers in China and India — threatens public health and national security.

The session opened with Chairman Buddy Carter saying, “The United States should never be dependent on the Chinese Communist Party for the antibiotics and essential medicines,” and continued with testimony from domestic manufacturers, trade groups and standard-setting bodies about concentrated production of active pharmaceutical ingredients (APIs) and key starting materials (KSMs), dwindling U.S. capacity, and the practical steps needed to restore resilience.

Why it matters: witnesses described a supply chain that is “longer, more fragmented, and more opaque” and identified a set of interlocking problems — low prices for many generics, concentrated upstream production of KSMs, slow permitting and long build times for new plants, and insufficient inspection capacity — that together increase the risk of shortages and unsafe products reaching patients.

Direct evidence and proposals presented included:
- Patrick Cashman, president of US Antibiotics, described his Bristol, Tennessee plant as the last end‑to‑end U.S. producer of amoxicillin and urged ‘‘long‑term purchasing agreements’’ and a government antibiotic manufacturing fund to provide predictable demand and finance investment. He said U.S. Antibiotics now has about a 5% market share and that adding shifts and lines could materially increase output within roughly 18–24 months.
- The United States Pharmacopeia (USP) reported mapping that shows high geographic concentration of KSMs and APIs; USP recommended creating a resiliency benchmark for purchasers, expanding supply‑chain visibility and investing in advanced manufacturing technologies.
- The Association for Accessible Medicines urged a suite of incentives — guaranteed purchase contracts, tax credits, simplified regulatory pathways and funding for domestic API capacity — to make U.S. manufacturing economically viable.
- The National Association of Boards of Pharmacy described early results from Pulse, a state‑facing implementation tool under the Drug Supply Chain Security Act (DSCSA) that has already helped detect illegitimate products in the field.

Members on both sides pressed witnesses on practical steps: how quickly domestic capacity can expand, whether FDA inspection capacity is sufficient to ensure quality as production reshoring accelerates, and how federal purchasing and stockpiles should be used to sustain domestic suppliers. Representative Diana DeGette and Ranking Member Frank Pallone raised concerns about proposed FDA staffing cuts and the impact on inspections and approvals, while other members emphasized tax and permitting reforms to speed construction and retrofitting of manufacturing lines.

The hearing included repeated references to existing authorities and tools — the Strategic National Stockpile (SNS), the Pandemic and All‑Hazards Preparedness Act (PAHPA), the Defense Production Act, and the Drug Supply Chain Security Act — as levers to shape demand and support domestic capacity. Witnesses and some members urged long‑term contracts, buy‑American procurement when U.S. capacity exists, and strategic stockpiles that include finished drugs and critical upstream ingredients.

Looking ahead: witnesses stressed that rebuilding domestic capacity will take time and coordinated policy: some reopening or scale‑up can be accomplished in 18–24 months with predictable contracts, while building new API facilities typically takes several years and hundreds of millions in capital. Committee members told witnesses they will press for follow‑up work and written materials; members may pursue legislative fixes on procurement, tax incentives, PBM and reimbursement reforms, and regulatory streamlining.

The hearing produced policy recommendations rather than votes; members said they would submit additional questions for the record and consider legislation to implement purchasing and incentive proposals.","A House Energy and Commerce subcommittee hearing spotlighted risks in the U.S. pharmaceutical supply chain, with witnesses and members urging long-term federal purchasing, inspection capacity and targeted incentives to rebuild domestic production of APIs, key starting materials and finished medicines.","actionData","errors"]

Article not found

USP: mapping shows upstream concentration of APIs/KSMs; calls for benchmarks and advanced manufacturing support

State boards and NABP pilot Pulse to detect counterfeit meds as DSCSA deadlines approach

Witnesses warn FDA staffing cuts and slowed inspections would worsen drug shortages and safety risks

Last U.S. amoxicillin maker urges long‑term federal contracts to secure supply

House subcommittee hears bipartisan concerns over U.S. dependence on foreign drug supply chains