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CENTER FOR AMERICAN MEDICINE Resiliency

CENTER FOR AMERICAN MEDICINE ResiliencyCENTER FOR AMERICAN MEDICINE ResiliencyCENTER FOR AMERICAN MEDICINE Resiliency

CENTER FOR AMERICAN MEDICINE Resiliency

CENTER FOR AMERICAN MEDICINE ResiliencyCENTER FOR AMERICAN MEDICINE ResiliencyCENTER FOR AMERICAN MEDICINE Resiliency

RESTORE AMERICA'S MEDICINE RESILIENCY- NATIONAL SECURITY

OUR MISSION:

Just as our nation values food security and energy resilience, achieving affordable medicine resiliency is a vital pursuit for America.


Health is a cornerstone of American life. It fuels our thriving society, boosts our economy through improved public health outcomes and increased productivity, and reinforces military preparedness and national security. It impacts all sectors, from Wall Street to Main Street and from commerce to defense. Affordable medicine stands as a fundamental pillar of America's infrastructure. It drives superior health outcomes, reduces the weight of healthcare costs for businesses and families alike, and promotes stronger economic participation through enhanced spending power.


It is essential for Americans to comprehend the intricate interconnections, vulnerabilities, and dependencies within the global supply chain, particularly those linked to China. Our mission is to deepen this understanding and protect America's national security by de-risking the affordable medicine supply chain through domestic and trusted allied manufacturing.


By mitigating overdependence on China by the U.S. and trusted allies, we can restore diversification in the active pharmaceutical ingredients (APIs,), Key Starting Material (KSMs) and crucial chemicals for affordable medicines, safeguarding the health, freedom, and prosperity of America - both now and for future generations.



The Stakes Are High:

Access to affordable medicine is vital for our nation's security, prosperity, resilience, and global leadership. Yet, the extensive global reliance on China for indispensable components of affordable generics injects deep uncertainties and vulnerabilities in our nation's and the globe's supply chain.


Here are the facts: 

 

  • Affordable generics are used over 90% of the time to fill U.S. prescriptions, accounting for only 18% of total pharmaceutical expenses and 3% of the total healthcare spending.


  • China supplies over 70% of the global active pharmaceutical ingredients (APIs), Key Starting Materials (KSMs,), intermediates and chemicals used for affordable medicines. 


  • Pharmaceuticals are the 5th largest import to the U.S. - China, India, & Mexico account for 50% of all U.S. imports by weight in 2020.


  • India, however, relies on China for 70% of the APIs and KSMs and is even more dependent on China for intermediates and processed chemicals, revealing a complex chain of dependencies. This pattern of dependency extends to other U.S. trading partners, including the UK, EU, Canada, and Mexico, for API and chemicals for affordable medicine.


  • 80% of chemicals used to make drugs sold in Europe now originate from China and India accordingly to the EFCG. 


  • China is the primary source of valuable inputs to U.S. chemistry manufacturing processes, and for which few or no alternatives exist as stated by the American Chemical Council.


 

Urgent Action Is Required:

Our nation must immediately mobilize resources and attention towards domestic and allied manufacturing of affordable medicines and their components. No-one country can do this alone. This initiative lies at the heart of our nation's fabric.


It will bolster our public health, regain certain domestic manufacturing, spur economic growth, fortify our industrial and military sectors, and propel socioeconomic advancement.  Simply put, it will protect America's health, national security, and future prosperity.  


Similar to efforts in the CHIPS Act for semiconductors and Inflation Reduction Act (IRA) for clean energy, America must advance medicine resiliency. 


It's time to:

 

  •  Regain U.S. production of APIs, KSMs, and advanced chemicals for crucial affordable medicine; and 


  •  Collaborate with strategic allies to manufacture APIs, intermediates, KSMs and other required chemicals. 


By swiftly investing in and incentivizing domestic and trusted allied affordable medicine API, KSMs, and chemical manufacturing, we can effectively strengthen the global leadership of the U.S.  


The stakes have never been higher. 















Support Medicine Security:

Join us in the urgent mission to drive America's medicine resiliency. Your decisive actions as community and business leaders are crucial in securing a healthier future for your organization, community, family, and those you serve. 


Together, let's make a lasting impact and forge a brighter future for our children.

Find out more

FAR REACHING IMPACTS of overdependency on One foreign nation

NATIONAL SECURITY

ECONOMIC SECURITY

ECONOMIC SECURITY

 The excessive dependence on China for APIs, KSMs and other chemicals, necessary for affordable medicine production worldwide, is an immediate national security threat.


The troubling history of China's threats to limit API exports and their previous instances of export bans on rare minerals, to both Japan and the U.S., highlights the urgen

 The excessive dependence on China for APIs, KSMs and other chemicals, necessary for affordable medicine production worldwide, is an immediate national security threat.


The troubling history of China's threats to limit API exports and their previous instances of export bans on rare minerals, to both Japan and the U.S., highlights the urgency for reducing this dependency.


We must protect against the potential weaponization of medicines, ensure the well-being of our troops and leaders, strengthen defense capabilities, fortify supply chain resilience, and enhance overall national preparedness. 



ECONOMIC SECURITY

ECONOMIC SECURITY

ECONOMIC SECURITY

 The importance of affordable medicine traverses far beyond the boundaries of mere cost savings.  

Affordable medicine contributes to the robust health of the U.S. economy by reducing the burden of healthcare costs for businesses and families alike, as well as facilitating greater spending power and economic participation. It empowers a he

 The importance of affordable medicine traverses far beyond the boundaries of mere cost savings.  

Affordable medicine contributes to the robust health of the U.S. economy by reducing the burden of healthcare costs for businesses and families alike, as well as facilitating greater spending power and economic participation. It empowers a healthier workforce, leading to increased productivity and less time lost to illness. In the context of military readiness, access to affordable medicine ensures that service members are healthy and ready for duty, contributing to a prepared and responsive defense force. In essence, affordable medicine is not merely a cost-saving strategy; it underpins the very fabric of our nation's prosperity, resilience, and global leadership.


By making investments, we can bolster our economy, foster job creation, and enhance the health of our workforce. 

PUBLIC HEALTH

ECONOMIC SECURITY

PUBLIC HEALTH

Affordable medications, which make up over 90% of dispensed drugs in the U.S., play an irreplaceable role in our healthcare system with mere 3% of overall U.S. healthcare spending.


Our deep dependencies on a single foreign nation for the vital components of these everyday medicines introduces tremendous risks. 


In the worst-case scenario, m

Affordable medications, which make up over 90% of dispensed drugs in the U.S., play an irreplaceable role in our healthcare system with mere 3% of overall U.S. healthcare spending.


Our deep dependencies on a single foreign nation for the vital components of these everyday medicines introduces tremendous risks. 


In the worst-case scenario, medication shortages would lead to decreased accessibility of everyday medicines, turning easily treatable conditions into life-threatening ones - with the most devastating impact falling on those already grappling with health inequities.

Product shortages would beget other shortages, leading to the U.S. healthcare system collapsing. 

MEDICINE INDEPENDENCE: A PRIORITY ISSUE FOR ALL

American Families

DOD: Military & Critical Personnel

American Families

American families rely on generics for better health and well-being.


  • 9 out of 10 U.S. prescriptions are filled with affordable generics.  


  • 1 in every 2 U.S. adults suffer from a chronic condition, and 27% of U.S. adults have multiple chronic conditions. 


What happens if we experience delays or lack access to affordable medicine? 


  •  Adults with heart disease, who have to wait longer than 30 days for their first dose of medication, are more likely to have a heart attack or stroke within the next year. 


  • Children with cancer, who have to wait longer than 30 days for their first dose of chemotherapy, are more likely to have their cancer progress or relapse.


  • Adults with chronic diseases, who have to wait longer than 30 days for their first dose of medication, are more likely to be hospitalized within the following year and have more healthcare expenditures.


  • A study found that high prescription drug costs can lead to a number of public health problems, such as increased rates of chronic disease and death.


  • According to the U.S. Department of Health and Human Services, more than 5 million Medicare beneficiaries had difficulty affording their medications in 2019; Black and Latino beneficiaries were more likely than white beneficiaries to face cost-related barriers.




 

Business Leaders

DOD: Military & Critical Personnel

American Families

Business leaders play a critical role in mitigating health and financial insecurity risks.


  • 49% of U.S. health coverage is provided by businesses.


  • For employer-sponsored family health care plan, health care premiums have risen by 87% since 2000.  


  •  Despite their vital role, generic medicines comprise less than 3% of total healthcare expenditures and represent only 3% of health insurance premiums. This percentage is significantly lower than administrative costs, taxes, and fees incurred by these entities. 


  • By using generics in corporate health programs: 

  • ExxonMobil estimates that it saves $500 million per year. 
  • Walmart estimates that it saves $500 million per year.
  • General Electric estimates that it saves $300 million per year. 
  • Bank of America estimates that it saves $200 million per year.


  • 1% increase in therapeutic drug treatment is estimated to yield $2.4B in avoidable medical costs annually.


  • Good health translates into a more resilient and adaptable workforce, thereby enriching communities and stimulating a vibrant economy. 





DOD: Military & Critical Personnel

DOD: Military & Critical Personnel

DOD: Military & Critical Personnel

In the context of military readiness, access to affordable medicine ensures that the American military and key personnel can remain healthy and ready for duty. 


  •  The Department of Defense (DOD) has expressed concerns about access to medicine in the U.S.-China Security Commission. 


  • In 2020, DOD issued a report, titled "China's Use of the Pharmaceutical Supply Chain to Lever its Economic and Political Power. "   DOD warned among other things that China could use its control of critical medicines to "threaten or coerce the United States and its allies".


  • 2020 Report also warned of the devasting consequences if China was to withhold exports of critical medicines during a crisis, such as a pandemic. As we know, this threat was made to the U.S. and E.U during the COVID-19 pandemic. 

 

Key recommendations from the DOD report:


  • Diversify the sources of APIs and finished pharmaceuticals, which includes developing new domestic production capacity, and investing in research and development of new medicines.
  • Develop a coordinated strategy to ensure the security of the pharmaceutical supply chain. The United States should develop a coordinated strategy to ensure the security of the pharmaceutical supply chain. This strategy should involve all levels of government, as well as the private sector.


  • Increase public awareness of the challenges posed by China's control of the pharmaceutical supply chain. 


  • The Department of Veterans Affairs (VA) is responsible for providing care to U.S. veterans. 


  • In 2016, the VA reversed its policy on the Trade Agreements Act, allowing the procurement of previously excluded drugs made in China (known as TAA non-compliant drug products).


  • This decision coincided with the strengthening of globalization and trade relations; yet it allows the VA to procure medicines made in China. 



About the Center for American Medicine RESILIENCY

Who We Are:

How We Work:

Who We Are:

  • The Center for American Medicine Resiliency is the leading nonpartisan, nonprofit organization fighting to advance America's medicine independence.


  • We aim to educate and shape policy, trade, and governance with a keen focus on advancing the nation's medicine independence with a focus on access to affordable medicine regarding national security, economic security, public health, and health equity.


  • As private and public business and community leaders, we have come together to help solve one of today's most pressing issues.

What We Do:

How We Work:

Who We Are:

  • Champion policies, laws, and trade negotiations that ensure constant access to affordable medicine to promote the nation's security, health, economy.


  • Insist America's pharmaceutical supply chain be transparent, accountable, specifically as it relates to national security and health interests. 


  • Educate the American public and thought leaders, sharing information of the complex, regulated supply chain of affordable medicines in interstate commerce and how certain trade initiatives and policies pose significant risks to enforcing regulations to ensure high quality, efficacy and purity of U.S. medicines.



How We Work:

How We Work:

How We Work:

  • We aim to educate policymakers, public interest advocates, and industry leaders, and work with them to find innovative and practical solutions to policy challenges associated with advancing medicine resiliency.
  • We endeavor to bring experts on both sides of the aisle together who have deep, cross-cutting knowledge and experience on global pharmaceutical, business, policy, health, and related issues. 


  •  Work with close allies of America to advance medication supply chain diversification and ultimately, our nation's medication resiliency. 


GOVERNMENT REPORTS & RECOMMENDATIONS

          

March 2023: The Office of Science and   Technology Policy (OSTP): Advancing American Biotechnology and   Biomanufacturing Strategy 


· Developing national strategy for expanding domestic   biomanufacturing capacity using biomass to 

  produces APIs; and

· Strengthen domestic biomanufacturing workforce. 

· Expanding access to data for the bioeconomy. 

· Developing a national strategy for expanding domestic   biomanufacturing capacity. 

· Improving biotechnology regulation clarity and efficiency. 

· Strengthening and innovating   biosafety and biosecurity for the bioeconomy. 

 

November 2022, The U.S.-China Commission 2023 Report:  Renewing American Competitiveness.


· Create an Economic and   Security Preparedness and Resilience Office within the executive branch to    

   oversee, coordinate, and set priorities for cross-agency efforts to ensure resilient   U.S. supply chains and 

   robust domestic capabilities.

· Enact legislation requiring suppliers to the U.S. government in "critical" sectors to confidentially

  disclose all tiers of their contractors for the purpose of identifying U.S. supply chain 

  dependencies on China.

· In enacting legislation subsidizing reshoring or existing   production in the United States, Congress 

  should evaluate whether the   subsidies may lead to additional dependence on supply chains running 

  through or relying on China to serve that production. Congress should also consider providing tax 

  credits or grants to companies that reshoring or nearshore their supply chains.

· Direct the U.S. Food and Drug   Administration in cooperation with other federal agencies to identify

  and pharmaceutical products that utilize active pharmaceutical ingredients (APIs) and other

  Ingredients and inputs that are sourced directly or indirectly from the People's Republic of China and 

  develop alternative sourcing arrangements through available tools and resources, including Defense 

  Production Act authorities.

 

February 2022: The National Security Strategy for Pharmaceuticals  issued by the Biden Administration.


· Increasing the stockpile of critical drugs by 50% by 2025. 

· Enhancing intelligence threat sharing between the U.S. government and the pharmaceutical industry. 

· Promoting public-private collaboration to develop new technologies for securing the   pharmaceutical 

   supply chain. 

· Improving border control for counterfeit drugs by increasing inspections and using new technologies. 

· Supporting modern technology, such as blockchain, to track the movement of pharmaceuticals. 

 

June 2021: The Biden Administration: Building Resilient Supply Chains, Revitalizing American Manufacturing, and Fostering Broad-Based Growth


For resilience: 

· Fostering domestic manufacturing for critical medicines by identifying those currently manufactured 

  overseas and incentivizing their production in the U.S. 

· Funding R&D for technologies to secure the supply chain through improved tracking, tracing, and 

  counterfeit detection, and technology standards. 

· Collaborating with global allies to share supply chain vulnerability information, coordinate response 

  strategies, and establish WHO global standards. 


For affordability: 

· Boosting market competition by facilitating the entry of more generic and biosimilar medicines and 

  promoting transparency.

· Reforming the U.S. patent system for greater transparency, efficiency, and shorter patent protection 

  duration for new medicines. 

· Investing in R&D for new, affordable medicines and providing incentives for companies developing 

  these. 

 

November of 2020: The U.S.-China Security Commission Recommendations: Section 4: Pharmaceutical Supply Chain.


· Diversify the sources of APIs and finish pharmaceuticals.

· Develop a coordinated strategy to ensure the security of the pharmaceutical supply chain.

· Increase public awareness of the challenges posed by China's control of the pharmaceutical supply 

  chain.

· Work with allies to address the challenges posed by China's control of the pharmaceutical supply chain.

· Invest in research and development of new medicines.

 

June 2020: The Department of Defenses:

China's Use of the Pharmaceutical Supply Chain to Lever its Economic and Political Power" 


· Diversify the sources of APIs and finish pharmaceuticals.

· Develop a coordinated strategy to ensure the security of the pharmaceutical supply   chain.

· Increase public awareness of the challenges posed by China's control of the pharmaceutical supply 

  chain.

· Work with its allies to address these supply chain challenges. 


Also:

· Strengthen the U.S. regulatory system for APIs and finished pharmaceuticals.

· Invest in research and development of new technologies to produce APIs and finished pharmaceuticals.

· Develop a plan to respond to a disruption in the pharmaceutical supply chain.

 

November 2019: The US-China   Security & Economic Commission to Congress 


Informed Congress of several key findings: 

· China is   the world’s largest producer of active pharmaceutical ingredients (APIs), and   that US

   is heavily dependent on drugs that are either sourced from China or include APIs sourced from China, 

   especially true for generic drugs used to fill most US prescriptions.

· The Chinese   government has designated biotechnology as a priority industry as a part of its 13th Five-

  Year Plan and the Made in China 2025 initiative.

· China’s   pharmaceutical industry is not effectively regulated by the Chinese   government. 

· The U.S.   FDA struggles to guarantee the safety of drugs imported from China because of the small 

  number of FDA inspectors in country, the large number of producers, the limited cooperation from 

  Beijing, and the fraudulent tactics of many   Chinese manufacturers.

· Assess US Pharmaceutical capacity and reliance by holding Congressional hearings to   evaluate the 

  productive capacity of the U.S. pharmaceutical industry, assess   U.S. dependence on Chinese-made 

  pharmaceuticals and APIs and analyze the   FDA's capacity to assure the safety of imports from China.

· Enact legislation requiring federal health systems to purchase pharmaceuticals from U.S. production 

  facilities or those FDA-certified facilities that meet U.S.   health and

· The FDA should investigate and confirm to Congress whether Chinese pharmaceutical   industry 

   regulations for safety match U.S. standards. If not, the FDA should   propose a plan for safeguarding 

  Americans from unsafe or contaminated drugs   manufactured in China.

· Enact legislation be considered to require generic drug manufacturers supplying to the U.S. Department 

   of Defense and Veterans Affairs to disclose potential   drug shortages or supply disruptions due to 

  dependencies on China.

    





    

Get More Information

Center for American Medicine Resiliency -- Making a Differ

Board of Directors

  •   Rear Admiral Ali S. Khan, M.D. Former Assistant Surgeon General - Dean of the College of Public Health and Retired Assistant Surgeon General at the Univ. of NE Medical School
    (Former Director of the Office of Public Health Preparedness and Response at the Center for      Disease Control and Prevention).  ali s. khan" | Search | LinkedIn


  • Admiral Scott Giberson, President & CEO AMI Healthcare; Former Assistant U.S. Surgeon General, acting Deputy Surgeon General, and Two Star Admiral with the U.S. Public Health Service. Scott Giberson, RPh, MPH, D.Sc | LinkedIn


  • Randy Edeker, Chairman of the Board, Hy-Vee. Randy Edeker (nationalrestaurantshow.com); Hy-Vee’s Randy Edeker tabbed as new FMI Chairman   (supermarketnews.com) 


  • Christine Mundkur, Board Director for Cardinal Health; Former President and CEO of Sandoz Pharmaceuticals. Christine Mundkur | LinkedIn


  • Mira Ricardel is a national security expert and former federal political appointee and is a partner Chertoff Group.  https://www.chertoffgroup.com/mira-ricardel-principal-strategic-advisory-services/


  • Rick Gates, Senior Vice President and Chief Pharmacy Officer of Walgreens Boots Alliance. Rick Gates |  Walgreens Boots or Alliance Rick Gates | Walgreens Boots Alliance


  • Adam Kaplan, M.D., Co-Founder, President, CSO of Mira Pharmaceuticals and Adjunct Professor at John Hopkins School of Medicine. https://www.linkedin.com/in/adam-kaplin-4b0a53a/


  • Joceyln Konrad, Chief of Stores, Family Dollar. https://www.linkedin.com/in/jocelyn-konrad/


  • Steve Anderson, President & CEO of National Ass'n of Chain Drug  Stores. NACDS PRESIDENT | NACDS


  • Camilla Sullivan, V.P. of Brand for Fannie Mae.  Camilla Sullivan | LinkedIn


  • Mike Duteau, President of Noble Healthcare Services, KPH Healthcare Services, Inc. Mike  Duteau | LinkedIn


  • Sean Connaughton, President & CEO of Virginia Hospital and Healthcare Association  Sean Connaughton | LinkedIn 


  • Joe Renner, Chairman of the Board of Zydus Pharmaceuticals .AAM Lifetime Achievement      Award - Joe Renner | Association for Accessible Medicines (accessiblemeds.org)


  •  Kathleen Jaeger, President & CEO, Center for American Medicine Resiliency. linkedin.com/in/kathleen-jaeger-11413a44 


Center’s Advisory Board: 

  • Peter Cressy RADM (Ret.) About George Washington Leadership Institute (gwleadershipinstitute.org)


Drug Shortages

U.S.  FDA's 2020 report on drug shortages outlines the root causes of drug shortages:



  • Lack of Incentives to Produce Less Profitable Drugs: Intense price competition, uncertain revenue streams, and high investment requirements make it less attractive for manufacturers to produce older generic drugs. Current contracting practices contribute to these dynamics.


  • The Market Doesn't Recognize or Reward Quality Management: There's minimal market recognition for mature quality management systems. Drug purchasers lack the information needed to assess the quality of a manufacturing facility, and there is no incentive for manufacturers to invest in quality and redundancy.


  • Logistical and Regulatory Challenges Impede Market Recovery: Increasing supply chain complexity and the need for approvals from multiple national regulatory bodies make it difficult for the market to recover following a disruption. 


FDA 2020 report provides the following recommendations.

:

  • Increase Transparency in Contracting Practices: More systematic study of current contracting practices can promote reliable access to affordable drugs.


  • Create a Rating System for Quality Management Systems: A rating system can incentivize manufacturers to invest in quality management systems and provide purchasers with necessary information about the quality of their products.


  • Promote Sustainable Private Sector Contracts: Contracts should provide financial incentives and rewards for quality manufacturing to ensure a reliable supply of important generic drugs.


Resources on U.S. drug shortages


  • FDA 2022 Shortage Report https://www.fda.gov/media/131130/download


  • FDA CDER’s drug shortage list https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm; 
  • FDA CBER’s drug shortage list https://www.fda.gov/vaccines-blood-biologics/safety-availabilitybiologics/cber-regulated-products-current-shortages


  • Resilient Drug Supply: Critical Acute Drugs: University of Minnesota//www.cidrap.umn.edu/resilient-drug-supply/resilient-drug-supply-critical-acute-drugs


  • Medicine For EU Fact Sheet Shortages https://ww.medicinesforeurope.com/wp-content/uploads/2023/03/factsheet-medicines-shortages-v3-low.pdf




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