U.S. Pharmacopeial Convention: Pharmaceutical Supply and Payment Chain Coalition Statement on the Biden-Harris Report Outlining Steps to Strengthen Critical Supply Chains

WASHINGTON, July 31 (TNSPol) (TNSCapv) -- The U.S. Pharmacopeial Convention issued the following joint agency statement with nine organizations:

The co-signers are Academy of Managed Care Pharmacy, American Pharmacists Association, American Society of Health-System Pharmacists, Association for Accessible Medicines, Consumer Healthcare Products Association, Food Industry Association, National Association of Chain Drug Stores, National Association of Specialty Pharmacy, Pharmaceutical Care Management Association.

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The Pharmaceutical Supply and Payment Chain Coalition issued the following statement in response to the Administration's 100-day review of the actions needed to address vulnerabilities in our nation's pharmaceutical supply chain and what measures need to be taken in order to strengthen the security of the domestic drug supply ("Building Resilient Supply Chains, Revitalizing American Manufacturing, and Fostering Broad-based Growth").

"Like this administration, we are committed to the health and safety of the drug supply chain, both global and domestic. Our representative organizations comprise America's pharmaceutical supply and payment chain, including prescription and over-the-counter brand and generic manufacturers; pharmacies and pharmacists across all practice settings, including health systems and hospitals, community, supermarkets, specialty, and managed care; wholesalers; pharmaceutical quality standard developers; employers and other health plan sponsors; health insurance providers; and pharmacy benefit managers.

"We commend the Biden-Harris administration for its thoughtful and thorough measures laid out in the report aimed at enhancing the security of the pharmaceutical supply chain. Our coalition stands ready to work with the Administration on the steps necessary to help ensure safe and reliable access to medicines."

In an April 19, 2021 statement and January 2021 letter to President Biden, the coalition urged the Administration to promote resiliency and diversity of the global pharmaceutical supply chain, specifically referring to its May 27, 2020 Guiding Principles to Promote Undisrupted Patient Access to Medications.

Click here to read: Guiding Principles to Promote Undisrupted Patient Access to Medications: https://www.pcmanet.org/americas-pharmaceutical-supply-and-payment-chain-collaborating-to-promote-undisrupted-patient-access-to-medications/

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January 14, 2021

To: President-Elect Joseph R. Biden, 1401 Constitution Avenue, NW, Washington, DC 20230

Dear President-Elect Biden:

On behalf of the Pharmaceutical Supply and Payment Chain Coalition (the Coalition), we write to congratulate you and offer our Coalition as a resource. Together, the Coalition and the companies and health care professionals we collectively represent help hundreds of millions of Americans get and stay well through high-quality, safe, and effective medicines. We look forward to working with your administration to respond to the COVID-19 pandemic by ensuring patients have access to much-needed medications, preventative treatments, and countermeasures, including vaccines.

The Coalition comprises 19 member organizations representing America's pharmaceutical supply and payment chain, including prescription and over-the-counter brand and generic manufacturers; pharmacies and pharmacists across all practice settings, including health systems and hospitals, community, supermarkets, specialty, and managed care; wholesalers; pharmaceutical quality standard developers; employers and other health plan sponsors; health insurance providers; and pharmacy benefit managers. Convened at the onset of the pandemic, the Coalition's primary concern remains the health and well-being of patients. We recognize that all of us in the pharmaceutical supply and payment chain have a responsibility to take action to help prevent and mitigate drug shortages and ensure patient access to care. Open dialogue, engagement, and effective collaboration across the public and private sectors are important for mitigating challenges and ensuring the supply chain continues to function well.

While there are many significant challenges facing our country, none are more immediate than the COVID-19 pandemic. As you lead the transition and determine priority issues, the Coalition welcomes the opportunity to serve as a resource to you on efforts to promote COVID-19 vaccine awareness and education and the safety and resiliency of the supply chain.

COVID-19 Vaccine Distribution, Awareness, and Education

The Coalition appreciates your prioritization of the COVID-19 response. In particular, we are encouraged to see a focus on mass immunization against the coronavirus (SARS-CoV-2), including planning for and ensuring equitable distribution of the vaccine that prioritizes the most critically vulnerable populations, health care personnel, essential workers, older Americans, and underserved communities, especially communities of color; investing in existing national, state, and local vaccine infrastructure; leveraging logistics expertise to ensure resiliency in supply chains for critical medical countermeasures; and prioritizing the dissemination of clear, consistent evidence-based information to support confidence in authorized COVID-19 vaccines.

On October 22, 2020, the Coalition released Guiding Principles for Safe and Efficacious COVID- 19 Vaccine Development, Distribution, Allocation, and Mass Immunization, which include that distribution must be guided by a well-coordinated national strategy aligned with existing state and local strategies for the distribution of routine vaccines. The Coalition's members are committed to supporting the national strategy, whether by amplifying public health messaging; directing patients to vaccination sites and for second doses of the vaccine(s); supporting systems for monitoring vaccine allocation, adverse events, patient follow-up, and post event surveillance; or directly facilitating vaccine development, distribution, and administration. We appreciated the funding for vaccine distribution efforts included in the Consolidated Appropriations Act of 2021 enacted last year. We further encourage your administration to work closely with Congress to evaluate and respond to ongoing needs for supplemental funding for the Centers for Disease Control and Prevention (CDC), states, and other jurisdictions to cover operations related to the cost of planning, preparing for, distributing, facilitating administration of, and promoting awareness and education about COVID-19 vaccines.

Surveys by the Reagan-Udall Foundation for the U.S. Food and Drug Administration (FDA) found that health care professionals, including grocer and neighborhood pharmacists, are the most trusted messengers to respond to concerns about the safety and efficacy of the COVID-19 vaccine. The Coalition encourages continued collaboration between private sector stakeholders, FDA, CDC, and state and other jurisdictions' public health leaders to amplify vaccine awareness and support mass immunization.

Supply Chain Resiliency and Adaptability throughout the Pandemic

This global pandemic has raised the possibility of shortages, as medicines normally used by only a few people may suddenly be needed by many; patients seek early refills or expanded supplies to shelter-in-place; or manufacturing centers are temporarily sidelined to preempt virus spread. All stakeholders in the pharmaceutical supply and payment chain have an important role in balancing patient access and continuity of care now and avoiding drug shortages and supply disruptions in the future. Throughout the COVID-19 pandemic, the supply chain has demonstrated resilience, adaptability, and responsiveness to evolving conditions--with a singular focus on maintaining reliable patient access to medicines.

The companies, organizations, and health care professionals we represent continuously assess their supply chains for shortages and potential disruptions; collaborate with federal, state, and local public health agencies to share critical information; and partner on efforts to sustain access to care with as little disruption as possible. As a result, and despite challenges, the supply chain continues to be strong, secure, and resilient, and Americans continue to have access to a safe, quality, and reliable supply of medicines. Deloitte found that during the first 90 days of the COVID- 19 pandemic, supply chain stakeholders leveraged their strong relationships and prior emergency response experience to anticipate changes in demand, respond to evolving patient needs, and mitigate disruptions, including handling surges, to maintain reliable access to medicines.

We ask that your administration maintain stability within the supply chain, as much as possible, during the pandemic, including by avoiding measures that could trigger protectionist responses and instead by deepening relationships with international trading partners to promote resiliency and diversity of the global pharmaceutical supply chain. We also support manufacturing in the United States and exploring incentives to maintain, utilize, and attract investment in domestic manufacturing.

On May 27, 2020, the Coalition released America's Pharmaceutical Supply and Payment Chain Collaborating to Promote Undisrupted Patient Access to Medications, which includes principles to help ensure a well-functioning supply chain and patient access to care. The Coalition has significant expertise mitigating drug access concerns, and we offer ourselves as a resource to the transition team to work collaboratively to identify and address supply chain challenges during the COVID-19 pandemic and beyond.

There are many components to safe and efficacious COVID-19 vaccine development, distribution, allocation, and mass immunization that depend on the expertise of, and collaboration with, the private sector. From the advancement of vaccine candidates to the leveraging of logistics expertise for distribution, from the grocers and neighborhood pharmacies serving as point-of-care sites across the country to the systems for monitoring adverse events and reminding of second doses, public-private collaboration continues to be critical to our nation's response to the pandemic.

The Coalition looks forward to having the opportunity to work with you or your senior advisors in the best interest of the individuals and families that we collectively serve.

Should you need a single point of contact to the organizations representing most of the pharmaceutical supply and payment chain, we encourage you to contact the Coalition, and we can share contact information or facilitate introductions or a discussion. We can be reached through Jocelyn Wiles, senior director of Federal Affairs for the Pharmaceutical Care Management Association, at (202) 756-5739 or [email protected].

Sincerely,

Academy of Managed Care Pharmacy

America's Health Insurance Plans

American Pharmacists Association

American Society of Health-System Pharmacists

Biotechnology Innovation Organization

Blue Cross Blue Shield Association

US Chamber of Commerce

Consumer Healthcare Products Association

FMI - the Food Industry Association

Healthcare Distribution Alliance

National Association of Specialty Pharmacy

National Community Pharmacists Association

National Grocers Association

Pharmaceutical Care Management Association

Pharmaceutical Research and Manufacturers of America

US Pharmacopeia