Our nation is at a defining moment, as we transition to a new administration and Congress and continue to respond to the COVID-19 pandemic. From a health care delivery perspective, the logistics expertise of our industry has never been more relied upon, and scrutinized, than it is today. As the calendar turns to 2021, eradicating COVID-19 will depend on a supply chain that is moving forward — safely, securely and efficiently. Collaborative relationships, among health care stakeholders and between the public and private sectors, also will continue to be critical to ensuring much-needed treatments and medical supplies reach the right place at the right time.

Chip Davis

As the past year has shown, the 35 members of the Healthcare Distribution Alliance — who serve as a critical connection point between approximately 1,400 front-end manufacturers and more than 180,000 frontline providers — have risen to this challenge.

Designated as critical infrastructure by the federal government in March 2020, HDA distributors quickly mobilized, working around the clock to respond to this crisis. Likewise, the Alliance supported our members by actively coordinating on a daily basis with federal and state officials, including the Federal Emergency Management Agency, the Food and Drug Administration, the Drug Enforcement Administration (DEA) and the National Governors Association, to help remove regulatory roadblocks. Our efforts with key stakeholders were guided by our Policy Principles for Public Health Emergencies.

Quite frankly, while the demands of this public health crisis may have forced the supply chain to bend, it did not break. A report released last fall by the HDA Research Foundation and Deloitte Consulting LLP highlights this resiliency, affirming that in the first 90 days of the pandemic, the U.S. pharmaceutical supply chain quickly adapted and adjusted to protect the steady supply of critical medicines to hospitals, pharmacies and patients while also protecting the health and safety of their dedicated frontline ­employees.

The industry not only anticipated changes in demand, but responded to evolving patient needs and mitigated disruptions. By working with trading partners and all levels of government, distributors delivered medicines to the front lines while continuing to meet Americans’ daily health care needs.

As the HDA Foundation report concludes, responding to supply challenges requires adaptation. Most importantly, coordination and collaboration across the supply chain and with government is essential.

In 2021, HDA and our members are bringing forward the early lessons learned from the pandemic to current response efforts, particularly as the focus turns to the distribution of approved vaccines and ­treatments.

In policy principles released last year, HDA called on the federal government to leverage distributors’ broad infrastructure and expertise to ensure rapid and secure distribution of vaccines and therapeutics to points of administration. Additionally, we called for clear communication and transparency from the federal government as decisions are made related to prioritization, to reduce any confusion among health care supply chain stakeholders, state and local governments, and importantly, the public.

Several HDA members will play a key role in turning vaccines into vaccinations. From serving as a centralized distributor of approved vaccines and supply kits in phase one to network administrators in the CDC’s Federal Pharmacy Partnership Strategy for COVID-19, distributors stand ready to help move vaccines to sites of administration under the allocation and prioritization guidelines established by the government and public health experts.

Unprecedented demand for a COVID-19 vaccine will require extensive planning and coordination across the supply chain and at all levels of government. HDA members, ranging from large companies with national footprints to smaller, regional organizations, cover the entire country, and have long-standing relationships with federal agencies and state public health departments. HDA has encouraged the government to involve all its distributor members in contingency planning, so no time is lost if, and when, additional supply chain resources are required.

HDA also is pleased that distributors have been recognized as vital partners by the U.S. government to distribute novel FDA-approved treatments as well as to support the Strategic National Stockpile.

If further logistics capabilities are needed to make sure every American has access to COVID-19 treatments and vaccines, HDA members are ready to answer the call.

2021 priority issues

The health care policy issues that were front and center before the pandemic remain on our agenda. With the increased focus on how products move through the health care supply chain, HDA will be stepping up our efforts to make sure the role and value of the distribution industry is understood by policy makers at the federal and state levels.

Health care affordability: As an industry that already generates between $33 billion and $53 billion in savings to the U.S. health care ecosystem annually, HDA and our distributor members are committed to the affordable, accessible and secure delivery of health care to all Americans.

As the new administration assesses health care affordability-related executive actions — ranging from prescription drug importation, which would undermine the safety of the supply chain along with industry product traceability efforts, to the most recently introduced rules regarding prescription drug rebates and the “most favored nation model” — we urge careful consideration of these policies, so they do not negatively impact Americans’ access to millions of medicines.

Our industry stands ready to serve as a resource as we collaboratively explore workable solutions that will reduce health care costs yet ensure quality of care.

Supply chain resiliency: Patients depend on the uninterrupted delivery of their medicines, from the most common to the most complex. Part of the reason why this is possible is because of a robust and diversified global supply chain. But as we saw through the early surges of the pandemic, unforeseen disruptions may occur due to sourcing of active pharmaceutical ingredients and finished-dose medicines. While HDA supports increasing U.S. production capabilities for essential medicines and PPE, any effort should be well planned and gradual to avoid destabilizing the supply chain.

Prescription drug abuse: HDA and its members are committed to doing our part to address the prescription drug abuse epidemic in the U.S. Specifically, HDA is encouraged that the DEA has issued a proposed rule to provide guidance regarding the monitoring and reporting of “suspicious orders” of controlled substances, as is required by law, and we are participating in the rule-making process to support enhanced communication and coordination in response to this crisis.

As has been made clear through the early COVID-19 response, patients rely on certain controlled substances to ensure continuity of care. So, while we remain focused on ending this crisis, HDA will remain vigilant toward legislative solutions that might affect the access and affordability of these life-saving medicines.

Pharmaceutical traceability: Implementation of the Drug Supply Chain Security Act (DSCSA) is an example of how the distribution industry’s collaborative spirit and expertise has enhanced the safety and efficiency of the supply chain. Given HDA and our members’ leadership on this issue for nearly two decades, the alliance remains engaged in this work from a technical, regulatory and governance standpoint.

Industry stakeholders continue to make progress toward overall compliance, although some priorities have shifted amid the COVID-19 response. While HDA is pleased the FDA extended enforcement discretion related to the saleable returns and dispenser-related milestones until 2023, we recognize implementation work must continue full speed ahead.

Through the work of an HDA-led task force, a production-ready network was established for the November 2020 saleable returns milestone. Stakeholders will use this additional enforcement discretion time to continue to conduct vital testing.

As we move closer to interoperable product serialization in 2023, and ultimately, an even safer and efficient supply chain for patients, we call upon our industry trading partners to continue to make the most of the additional time provided, learn about specific DSCSA data-sharing requirements, including the EPCIS standard and, above all, work collaboratively to achieve compliance.

A strong voice for the future

While the uncertainties of today have transformed our daily lives, distributors’ commitment to delivering an estimated 93% of the country’s prescription medicines and health care products where they are most needed is stronger than ever. As HDA evolves in lockstep with the industry we represent, you can expect to hear our members’ unique perspective loud and clear — in the next year and beyond — as we work collaboratively to fulfill this critical mission.

Chip Davis is the president and chief executive officer at the Healthcare Distribution Alliance.