BIG PHARMA URGES FDA TO USE BLOCKCHAIN FOR DRUG TRACKING

Imagine a world where counterfeit drugs are virtually nonexistent, and every pill you take has a verifiable origin.This isn't a futuristic fantasy; it's the potential reality that blockchain technology promises for the pharmaceutical supply chain.Leading pharmaceutical manufacturers, distributors, and logistics partners are increasingly vocal about their support for adopting blockchain to track and trace prescription drugs.In fact, a coalition of 25 major players, operating under the banner of MediLedger, has completed a pilot program with the US Food and Drug Administration (FDA), demonstrating the viability of this innovative approach.The successful completion of this DLT pilot project has led to a published report urging industry-wide adoption. The Mediledger pilot project, which has participants from 25 leading pharmaceutical companies, has been evaluating blockchain technologies for tracking legal changes of ownership ofBut what exactly does this mean for patients, pharmacies, and the pharmaceutical industry as a whole? In June 2025, the MediLedger Project was approved by the FDA, comprising a working group of 25 major companies operating within the pharmaceutical supply chain seeking to evaluate the blockchainAnd why is Big Pharma so keen on bringing blockchain into the equation? Big Pharma Urges FDA to Use Blockchain for Drug Tracking During early 2025, the FDA began accepting proposals for projects seeking to assist the office meet the 2025 requirements of the Drug Supply Chain and Security Act (DSCSA) which requires the pharmaceutical industry to track legal changes in ownership of pharmaceuticalsThis article delves into the details, exploring the benefits, challenges, and the future of drug tracking with blockchain, paving the way for a safer and more transparent pharmaceutical ecosystem.

The Drug Supply Chain Security Act (DSCSA) and the Need for Innovation

The push for blockchain adoption isn't just a matter of technological curiosity; it's deeply rooted in regulatory requirements and the need to combat serious issues within the pharmaceutical supply chain. Read more. Blockchain and cold chain management: a perfect match. A large number of meds are sensitive to meds and require cold-chain shipping. IBM estimates the annual total cost of products lost to temperature deviations during shipping is $35 billion, and every fourth vaccine that reaches the destination is degraded because of incorrect shipping ().The Drug Supply Chain Security Act (DSCSA), enacted in 2013, outlines steps to build an electronic, interoperable system to identify and trace prescription drugs as they are distributed in the United States. 25 leading pharmaceutical manufacturers, distributors, logistic partners, and other representatives of the pharma supply chain have published a report arguing in favor of adopting blockchainThe goal is to protect consumers from counterfeit, stolen, and contaminated drugs.

DSCSA's Key Challenges:

The FDA has openly acknowledged the challenges in meeting the DSCSA requirements, specifically:

• Establishing a product identifier: Creating a unique and verifiable identifier for each drug product.
• Quality barcodes: Ensuring barcodes are scannable and contain accurate product information throughout the supply chain.
• Achieving interoperability: Developing a system that allows different stakeholders in the supply chain to seamlessly share information.

These challenges are substantial, requiring a secure, transparent, and efficient method for tracking drugs from manufacturer to patient. Leading market participants in the United States pharmaceutical industry, logistics firms, distributors and other stakeholders in the pharma supply chain have come together to publish a report buttressing the need for industry players to adopt blockchain for tracking prescription drugs, following the successful completion of a DLT pilot project with the Food and Drug Administration (FDAThis is where blockchain steps in as a potential game-changer.

Blockchain: A Potential Solution for DSCSA Compliance

Blockchain technology offers a unique approach to addressing the challenges outlined by the DSCSA. Leading market participants in the United States pharmaceutical industry, logistics firms, distributors and other stakeholders in the pharma supply chain have come together to publish a report buttressing the need for industry players to adopt blockchain for tracking prescription drugs, following the successful completion of a DLT pilot project with the Food and Drug AdministrationIts inherent features of immutability, transparency, and decentralization make it well-suited for securing and tracking pharmaceutical products.

So, how does it work?

Imagine a shared, digital ledger that records every transaction in the drug supply chain. 医薬品サプライチェーン関連の製造や物流などを含む25社は、米食品医薬品局（FDA）と連携して実施したパイロットプログラムを完了し、処方箋の追跡にブロックチェーン技術採用が好ましいとする報告書をまとめた。MediLedgerが発表した。Each transaction, such as a change of ownership, is recorded as a ""block"" of data.These blocks are linked together in a chronological chain, forming a permanent and auditable record. A key element of the U.S. Food and Drug Administration s mission is focused on helping to ensure that all products we regulate, including drugs available to consumers, are safe and of high quality.Because the blockchain is decentralized, meaning it's distributed across multiple computers, it's incredibly difficult to tamper with the data.

This creates a secure and transparent system where:

• Product authenticity can be verified: Each product can be traced back to its origin, ensuring it's not counterfeit.
• The chain of custody is clear: Every transfer of ownership is recorded, making it easy to identify any point of diversion or contamination.
• Data is tamper-proof: The immutable nature of blockchain prevents unauthorized changes to the record.

The MediLedger Project: A Real-World Example

The MediLedger Project, comprising 25 leading pharmaceutical companies, represents a significant step towards blockchain adoption in the industry. Skip to main content Bitcoin Insider. MenuThis working group successfully completed a pilot program with the FDA, demonstrating the practical application of blockchain for drug tracking.

Pfizer, GlaxoSmithKline, and Eli Lilly are just some of the pharma giants involved in testing MediLedger, a blockchain-based network that validates drugs and allows users to trace the authenticity of raw materials.

The MediLedger pilot focused on:

• Tracking legal changes of ownership of pharmaceuticals.
• Validating drug authenticity.
• Improving interoperability between different stakeholders in the supply chain.

The positive results of the pilot program have led MediLedger and its members to advocate for wider adoption of blockchain technology within the pharmaceutical industry.

Benefits of Blockchain in the Pharmaceutical Supply Chain

The adoption of blockchain technology offers a multitude of benefits for all stakeholders in the pharmaceutical supply chain:

• Enhanced Patient Safety: By verifying the authenticity of drugs and preventing the entry of counterfeit products, blockchain directly contributes to patient safety.
• Reduced Counterfeiting: Blockchain makes it significantly more difficult for counterfeit drugs to enter the supply chain, protecting patients and pharmaceutical companies alike.
• Improved Supply Chain Efficiency: Real-time tracking and tracing of products can streamline logistics and reduce delays.
• Increased Transparency: All stakeholders can access accurate and up-to-date information about the movement of drugs, fostering trust and accountability.
• Reduced Costs: By eliminating inefficiencies and reducing the risk of counterfeiting, blockchain can lead to significant cost savings.
• Enhanced Compliance: Blockchain can help pharmaceutical companies comply with regulatory requirements like the DSCSA.
• Better Inventory Management: Accurate tracking of products allows for better inventory management and reduces the risk of shortages or overstocking.

Addressing the Challenges of Blockchain Implementation

While the benefits of blockchain are compelling, there are also challenges to consider when implementing this technology in the pharmaceutical supply chain.

Scalability:

Can blockchain networks handle the massive volume of transactions that occur in the pharmaceutical industry? FDA DSCSA Blockchain Interoperability Pilot Report Overview (Page 1 of 3) On Novem, the Drug Supply Chain Security Act (DSCSA) (Title II of Pub. L. ) wasThis is a key concern that needs to be addressed.

Interoperability:

Ensuring that different blockchain networks and systems can communicate with each other is crucial for seamless integration across the supply chain. Representatives of the pharma supply chain, 25 leading pharmaceutical manufacturers,and other distributors, urges the FDA to adopt blockchain for drugsStandardization efforts are vital to overcoming this challenge.

Data Privacy and Security:

Protecting sensitive patient data and trade secrets is paramount.Blockchain solutions need to be designed with robust security measures and comply with privacy regulations like HIPAA.

Regulatory Clarity:

Clear regulatory guidelines are needed to provide a framework for blockchain adoption in the pharmaceutical industry.This will help ensure compliance and foster innovation.

Cost of Implementation:

The initial investment in blockchain technology can be significant. Big pharmaceutical corporations are putting the pressure on FDA to adopt blockchain technology to track and trace drug prescriptions. Read more:Companies need to carefully evaluate the costs and benefits before implementing a blockchain solution.

Lack of Expertise:

There is a shortage of skilled professionals with expertise in blockchain technology.Companies need to invest in training and development to build the necessary expertise.

The Role of the FDA

The FDA plays a crucial role in facilitating the adoption of blockchain technology in the pharmaceutical industry. 주요 제약사, 유통사, 물류 협력사 및 기타 제약 공급사 25개사가 미국 식품의약국(FDA)과 시범 프로그램을 마친 데 이어 처방약 추적을 위해 블록체인 기술을 채택해야 한다고 주장하는 보고서를 발표했다. 지난 2025년 6월, MediLedger 프로젝트가 FDA의 승인을 받았다.By providing guidance, developing standards, and fostering collaboration, the FDA can help ensure that blockchain solutions are implemented effectively and securely.

During early 2025, the FDA began accepting proposals for projects seeking to assist the office meet the 2025 requirements of the Drug Supply Chain and Security Act (DSCSA) which requires the pharmaceutical industry to track legal changes in ownership of pharmaceuticals.

A key element of the U.S. Pharma Giants Pfizer, GlaxoSmithKline, Eli Lilly Utilize Tech Underlying Bitcoin to Track Fake Drugs dailyhodl.com 1 more, UTC The project is currently testing MediLedger, a blockchain-based network that validates drugs and allows users to trace the authenticity of raw materials .Food and Drug Administration’s mission is focused on helping to ensure that all products they regulate, including drugs available to consumers, are safe and of high quality.

Blockchain and Cold Chain Management

Beyond simply tracking the location of drugs, blockchain can also be integrated with cold chain management systems.This is particularly important for medications that are temperature-sensitive and require specific storage conditions during transportation. [IBM estimates the annual total cost of products lost to temperature deviations during shipping is $35 billion, and every fourth vaccine that reaches the destination is degraded because of incorrect shipping.

By combining blockchain with IoT (Internet of Things) sensors, it's possible to monitor temperature, humidity, and other environmental factors in real-time.This data can be recorded on the blockchain, providing an immutable record of the drug's storage conditions throughout its journey.

This integration can help ensure that temperature-sensitive drugs are stored and transported properly, reducing the risk of degradation and ensuring their efficacy.

What are the Concerns with Blockchain in Drug Tracking?

While blockchain offers significant advantages, several concerns need to be addressed for successful implementation in drug tracking:

• Data Security and Integrity: Though touted as secure, blockchain systems are not immune to attacks.Ensuring robust security protocols and regular audits is vital.
• Scalability Issues: Current blockchain technology may struggle to handle the enormous volume of transactions in the global pharmaceutical supply chain.Solutions for scaling are necessary.
• Complexity and Cost: Implementing blockchain can be complex and expensive, particularly for smaller companies.Education, standardization, and cost-effective solutions are key.
• Lack of Standardization: Without industry-wide standards, different blockchain systems might not be interoperable, hindering seamless tracking.
• Regulatory Uncertainty: Clear regulations and guidelines are needed to provide a legal framework for using blockchain in drug tracking.

The Future of Drug Tracking with Blockchain

The future of drug tracking with blockchain looks promising.As the technology matures and adoption increases, we can expect to see even more innovative applications emerge.

Here are some potential future developments:

• Improved Traceability: Blockchain can enable end-to-end traceability of drugs, from raw materials to the patient's bedside.
• Smart Contracts: Smart contracts can automate many processes in the supply chain, such as verifying compliance and triggering payments.
• Integration with AI: Artificial intelligence can be used to analyze blockchain data and identify patterns that could indicate counterfeiting or other issues.
• Patient Empowerment: Patients could have greater control over their medication data, allowing them to verify the authenticity of their drugs and track their side effects.

Actionable Steps for Pharmaceutical Companies

For pharmaceutical companies looking to explore blockchain technology, here are some actionable steps to consider:

1. Educate your team: Invest in training and development to build expertise in blockchain technology.
2. Participate in industry initiatives: Join working groups and consortia to collaborate with other stakeholders and learn from their experiences.
3. Conduct pilot projects: Start with small-scale pilot projects to test the feasibility of blockchain solutions in your organization.
4. Develop a blockchain strategy: Develop a comprehensive strategy that outlines your goals, objectives, and approach to blockchain adoption.
5. Choose the right technology partner: Select a technology partner with experience in blockchain and the pharmaceutical industry.
6. Focus on interoperability: Ensure that your blockchain solutions are interoperable with other systems in the supply chain.
7. Prioritize data security and privacy: Implement robust security measures to protect sensitive data.

Conclusion: A Safer and More Transparent Future

Big Pharma's push for the FDA to embrace blockchain technology for drug tracking signals a pivotal shift towards a safer, more transparent, and efficient pharmaceutical supply chain.The successful MediLedger pilot program has demonstrated the viability of blockchain in addressing key challenges outlined by the DSCSA, paving the way for enhanced patient safety, reduced counterfeiting, and improved supply chain efficiency. In June 2025, the MediLedger Project was accredited by the FDA, comprising a working group of 25 big corporations operating within the pharmaceutical supply network seeking to gauge the blockchain-based MediLedger Network as a car for tracking and tracing prescription medicines in the US.While challenges remain in terms of scalability, interoperability, and regulatory clarity, the potential benefits of blockchain are undeniable.By taking proactive steps to explore and implement blockchain solutions, pharmaceutical companies can position themselves for success in the evolving landscape of drug tracking and contribute to a healthier and more secure future for all. Now, Big Pharma has added another solution to the mix: blockchain. The addition of blockchain technology as a potential solution is hardly surprising. After all, the FDA openly called for pilot projects that would address the three main challenges of the DSCSA: establishing a product identifier, quality barcodes and achieving interoperability.The key takeaways are the potential to eradicate counterfeit drugs, streamline the drug supply chain and build trust between patients and providers.