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FDA blockchain pilot program

Wes Turner
 

"FDA takes new steps to adopt more modern technologies for improving the security of the drug supply chain through innovations that improve tracking and tracing of medicines" 

- They're soliciting proposals through March 11
- FDA also works with "Identification of Medicinal Products (IDMP)" https://www.fda.gov/ForIndustry/DataStandards/ucm612442.htm

From the article:

"""
As part of these efforts, today, the agency is launching a new pilot project in which participants representing the drug supply chain (e.g., manufacturers, repackagers and other stakeholders) can pilot the use of innovative and emerging approaches for enhanced tracing and verification of prescription drugs in the U.S. to ensure suspect and illegitimate products do not enter the supply chain. Eligible entities may apply to participate in the program. The pilot will inform the development of the enhanced electronic, interoperable track-and-trace system for industry set to go into effect in 2023 as part of the Drug Supply Chain Security Act. This new program will pilot technologies that may become part of our enhanced expectations for reliable track-and-trace systems. The new system will be aimed at reducing diversion of drugs distributed domestically and will help keep counterfeit drugs from entering the supply chain, and ultimately, reaching patients.

“As part of our ongoing efforts to protect our nation’s drug supply, today, we’re giving industry an opportunity to test new technologies that can help spur greater accountability for participants in the supply chain and improve our ability to trace prescription drugs at every point in the distribution chain. Using new innovations, we believe we can improve the overall security of our closed system and improve our ability to prevent the introduction of illegitimate products, better detect the introduction of illegitimate products, and enable stakeholders and the FDA to respond more rapidly when such products are found,” said FDA Commissioner Scott Gottlieb, M.D. “We recognize that tracking and tracing products is critical to industry’s ability to detect and remove potentially dangerous drugs from the drug supply chain. This pilot is one of many steps we’re taking to foster innovative ways to improve the security of the drug supply. We’re also focused on making improvements across the other products we regulate, especially related to food and our ability to address foodborne outbreaks. We’re invested in exploring new ways to improve traceability, in some cases using the same technologies that can enhance drug supply chain security, like the use of blockchain. To advance these efforts, the FDA recently recruited Frank Yiannas, an expert on the use of traceability technologies in global food supply chains. He’ll be working closely with me on ways for the FDA to facilitate the expansion of such methods, such as blockchain technology, to further strengthen the U.S. food supply. Under his leadership, we’ll continue to leverage all tools available to ensure greater accountability. For the drug track-and-trace system, our goals are to fully secure electronic product tracing, which provides a step-by-step account of where a drug product has been located and who has handled it; establish a more robust product verification to ensure that a drug product is legitimate and unaltered; and to make sure that any party involved in handling drugs in the supply chain must have the ability to spot and quarantine and investigate any suspect drug. We’re committed to staying at the forefront of new and emerging technologies and how they might be used to create safer, smarter and more trusted supply chains to better protect consumer safety and ensure the integrity of the high quality of products they deserve.”

"""


Yiannis comes from Walmart; who bestowed an award to OriginTrail (an open source blockchain solution for supply chains)

Is there overlap in design goals for these projects?

It would be most efficient to have international open standards for this effort.
Is GS1 sufficient for cross-chain interoperability?
Might ILP (Interledger Protocol) be useful for this purpose?

Are there pilot program eligible entities working with Grid components at this point?

Who could recommend Grid for Supply Chain for these objectives and why?
As an open, Hyperledger, Linux Foundation project, what advantages does Hyperledger Grid offer supply chain solution seekers like FDA?

...
Wes Turner
 

DSCSA Pilot Program


On Tuesday, February 12, 2019, Wes Turner <wes.turner@...> wrote:
"FDA takes new steps to adopt more modern technologies for improving the security of the drug supply chain through innovations that improve tracking and tracing of medicines" 

- They're soliciting proposals through March 11
- FDA also works with "Identification of Medicinal Products (IDMP)" https://www.fda.gov/ForIndustry/DataStandards/ucm612442.htm

From the article:

"""
As part of these efforts, today, the agency is launching a new pilot project in which participants representing the drug supply chain (e.g., manufacturers, repackagers and other stakeholders) can pilot the use of innovative and emerging approaches for enhanced tracing and verification of prescription drugs in the U.S. to ensure suspect and illegitimate products do not enter the supply chain. Eligible entities may apply to participate in the program. The pilot will inform the development of the enhanced electronic, interoperable track-and-trace system for industry set to go into effect in 2023 as part of the Drug Supply Chain Security Act. This new program will pilot technologies that may become part of our enhanced expectations for reliable track-and-trace systems. The new system will be aimed at reducing diversion of drugs distributed domestically and will help keep counterfeit drugs from entering the supply chain, and ultimately, reaching patients.

“As part of our ongoing efforts to protect our nation’s drug supply, today, we’re giving industry an opportunity to test new technologies that can help spur greater accountability for participants in the supply chain and improve our ability to trace prescription drugs at every point in the distribution chain. Using new innovations, we believe we can improve the overall security of our closed system and improve our ability to prevent the introduction of illegitimate products, better detect the introduction of illegitimate products, and enable stakeholders and the FDA to respond more rapidly when such products are found,” said FDA Commissioner Scott Gottlieb, M.D. “We recognize that tracking and tracing products is critical to industry’s ability to detect and remove potentially dangerous drugs from the drug supply chain. This pilot is one of many steps we’re taking to foster innovative ways to improve the security of the drug supply. We’re also focused on making improvements across the other products we regulate, especially related to food and our ability to address foodborne outbreaks. We’re invested in exploring new ways to improve traceability, in some cases using the same technologies that can enhance drug supply chain security, like the use of blockchain. To advance these efforts, the FDA recently recruited Frank Yiannas, an expert on the use of traceability technologies in global food supply chains. He’ll be working closely with me on ways for the FDA to facilitate the expansion of such methods, such as blockchain technology, to further strengthen the U.S. food supply. Under his leadership, we’ll continue to leverage all tools available to ensure greater accountability. For the drug track-and-trace system, our goals are to fully secure electronic product tracing, which provides a step-by-step account of where a drug product has been located and who has handled it; establish a more robust product verification to ensure that a drug product is legitimate and unaltered; and to make sure that any party involved in handling drugs in the supply chain must have the ability to spot and quarantine and investigate any suspect drug. We’re committed to staying at the forefront of new and emerging technologies and how they might be used to create safer, smarter and more trusted supply chains to better protect consumer safety and ensure the integrity of the high quality of products they deserve.”

"""


Yiannis comes from Walmart; who bestowed an award to OriginTrail (an open source blockchain solution for supply chains)

Is there overlap in design goals for these projects?

It would be most efficient to have international open standards for this effort.
Is GS1 sufficient for cross-chain interoperability?
Might ILP (Interledger Protocol) be useful for this purpose?

Are there pilot program eligible entities working with Grid components at this point?

Who could recommend Grid for Supply Chain for these objectives and why?
As an open, Hyperledger, Linux Foundation project, what advantages does Hyperledger Grid offer supply chain solution seekers like FDA?

...
clive boulton
 
Edited

Earlier I designed and directed development of a popular track and trace system used by many small-to-midsize medical device manufacturers (well over 1000). GS1 provided little value because tier-2 / tier-3 systems are generally siloed and not interconnected with tier 1. Larger medical device manufactures and tier-1 phama who have multiple plants and outsource specialist processes to tier-2/3 are more likely to use GS1 standards more for interoperable barcodes. However they struggle with privacy and confidentiality because the majority of supply chain enterprise applications software is still built around the notion of centralized data silos. i.e. there is no 'Slack' for supply chain - tier-2 or tier-3 collaboration that I'm aware of. Thus in order to get adoption of blockchain based systems in tier-1. The problem to be solved lies in designing for sharing granular data without sharing business secrets in tier-2/3. This is more paramount where HIPAA takes precedence over FDA processes such as the requirement to keep patient complaint records and sharing this quality data with FDA to support product recalls. Thus gaining adoption of blockchain in supply chain in my option requires attention to solving privacy controls with verification of security and confidentiality i.e. solve selective sharing of data elements with different regulations (FDA / HIPAA) to allow one-up / one-down data sharing (it is easy to lose control as Facebook discovered with its Cambridge Analytica incident). The NSA's Apache Accumulo project has rigorous data sharing controls, provision these on blockchain and I expect adoption will follow.
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