Ensuring Safe, Effective Drugs Are Available to Patients
HDA and our pharmaceutical distributor members regularly work with policymakers, regulators and other supply chain stakeholders to tackle complex drug supply issues and help ensure the availability of safe and effective medicines.
Why Do Shortages Occur?
Product shortages, whether pharmaceuticals, healthcare products or medical supplies, are caused by many factors, including market-wide supply constraints, product-specific manufacturing issues, and reimbursement and market access limitations.
Other times, as was the case during the initial COVID-19 response, shortages occur due to a sharp rise in demand exceeding available supply. Disruptions in product availability and strain on existing supply chains have underlined the need for solutions to ensure adequate supply for patients.
Learn more about supply-driven and demand-driven shortages.
Distributors Help Manage and Mitigate Shortages
HDA pharmaceutical distributor members work at both ends of the supply chain — between more than 1,200 manufacturers and nearly 330,000 provider customers — to minimize disruptions for patients. Distributors regularly monitor for spikes in demand or dips in availability for products and proactively communicate with manufacturers, industry partners and regulators. When shortages do occur, distributors actively work to mitigate the impact on providers and patients.
HDA Policy Platform on Drug Shortages
There are several areas where supply chain stakeholders and the government can work together to address drug shortages:
- Strengthening partnerships between the public and private sectors;
- Identifying strategic federal investments in domestic manufacturing capabilities; and,
- Taking steps to stabilize the generics market.
HDA, with the guidance and expertise of its members, developed a set of guiding principles to inform how distributors approach policies and leading practices related to drug shortages. Read the guiding principles.
The industry is eager to partner with legislators, regulators and our supply chain partners on solutions to this complicated challenge. Read our policy agenda.
Resources
The resources below address the industry’s approach to enhancing access to lifesaving medicines and products.
- HDA Policy Agenda on Drug Shortages
- HDA Guiding Principles for Drug Shortages
- Fact Sheet: Responding to Drug Shortages
- Fact Sheet: Understanding Supply-Driven Drug Shortages
- Fact Sheet: Understanding Demand-Driven Drug Shortages
- Fact Sheet: What Are Drug Shortages and How Do They Differ?
- Drug and Medical Product Availability: Distributors Promote a Resilient Supply Chain (Fact Sheet)
- Understanding Drug Shortages
- Mitigating and Managing Drug Shortages
- HDA Comments on CMS Buffer Stock Proposal
- HDA Feedback on the Senate Finance Committee's Draft Drug Shortage Prevention and Mitigation Program
- HDA Response to the FTC/HHS RFI on Drug Shortages
- HDA Comments to FDA on QMM Program
- HDA Response to the Senate Finance Committee’s Draft Drug Shortage Prevention and Mitigation Program
- HDA Response to the Senate Finance Committee’s White Paper on Drug Shortages
- HDA Statement for the Record: “Examining Chronic Drug Shortages in the United States” (House Ways & Means Committee, February, 20, 2024)
- HDA Comments to CMS on Hospital Buffer Stock Proposed Rule
- HDA Statement for the Record: "Legislative Proposals to Prevent and Respond to Generic Drug Shortages" Hearing (House Energy & Commerce Health Subcommittee, September 14, 2023)
- HDA RFI Submission – Drug Shortages
Our Advocacy Work on Behalf of Members
HDA reviews key priority issues and advocates on behalf of its pharmaceutical distributor members in areas like standards, public policies and business processes. HDA members have a powerful, unique voice and perspective and an opportunity to help educate lawmakers and inform public policy.
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