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Yesterday, the United States Food and Drug Administration (FDA) announced plans to test new technologies, including blockchain, to facilitate traceability of pharmaceuticals. In 2013, the United States pbaded the Drug Supply Chain Security Act (DSCSA) to control the estimated $ 200 billion endemic market for counterfeit drugs worldwide. To meet this need, the pharmaceutical supply chain must become fully interoperable. This involves sharing information between manufacturers, repackers, wholesaler distributors, distributors and their suppliers.
The announcement also states that the FDA is piloting food traceability projects. At the end of last year, the FDA hired Frank Yiannas as Deputy Commissioner, Food Policy & Response. He has been leading food safety at Walmart for a decade and is a key partner in the IBM Food Trust blockchain initiative.
FDA is requesting applications to participate in pilot projects.
The problem of counterfeit drugs
DSCSA legislation will be phased in over 10 years, this year's focus being on returned drugs. Medications that are returned are often resold instead of being destroyed. It is necessary to check that returned items are not counterfeit before being resold. The proportion of drugs is low, between 2 and 3%, but amounts to nearly 7 billion dollars a year.
There are many initiatives to meet the requirements of the DSCSA. For example, SAP recently launched its blockchain pharmaceutical traceability solution, a co-innovation with Amerisource Bergen, Boehringer Ingelheim, GlaxoSmithKline, Merck and others.
The San Francisco-based startup, Chronicled, is managing the MediLedger project, which provides a complementary solution to the blockchain. He works with two of the largest wholesalers, Amerisource Bergen and McKesson, as well as the ten largest pharmaceutical companies Genentech, Pfizer and Gilead.
But not everyone is convinced that the industry is moving in the right direction. Especially for full implementation by 2023. "I do not think we can meet the deadline set by the DSCSA for 2023, even with a solution without blockchain," Ledger Insights said last year, industry consultant Jeffrey Stollman. He believes that the challenge is governance. "You need rules and there is currently no organizational structure to create these rules."
The FDA does not mention governance, but says the pilot project is "intended to help identify and evaluate the most efficient processes and / or systems for operationalizing supply chain security requirements." And she wants to share the lessons learned with the sector.
FDA statement
FDA Commissioner Scott Gottlieb made the following statement:
"As part of our ongoing efforts to protect our country's drug supply, we are now giving the industry the opportunity to test new technologies that can further empower chain participants." supply and improve our ability to track prescription drugs at any time. in the distribution chain. "
"By using new innovations, we believe that we can improve the overall security of our closed system and our ability to prevent the introduction of illegitimate products, to better detect the introduction of illegitimate products and to allow the parties stakeholders and the FDA to respond more quickly when such products are found. "
"We recognize that product tracking is critical to the industry's ability to detect and remove potentially dangerous drugs from the drug supply chain. This pilot project is one of many steps we are taking to promote innovative ways to improve the security of drug supply. "
"We are also focused on making improvements to the other products we regulate, including food and our ability to cope with foodborne outbreaks. We are invested in exploring new ways to improve traceability, using in some cases the same technologies that can enhance the safety of the drug supply chain, such as the use of the blockchain. "
"To advance these efforts, the FDA recently recruited Frank Yiannas, an expert in the use of traceability technologies in global food supply chains. He will work closely with me to find ways for the FDA to facilitate the development of such methods, such as blockchain technology, to further strengthen the US food supply. Under his leadership, we will continue to leverage all available tools to ensure greater accountability. "
"In terms of the drug tracking and tracing system, our goals are to fully secure electronic product tracing, which provides a detailed account of the location of a drug product and the people behind it." Have handled it. establish a more robust product verification to ensure that a drug product is legitimate and unaltered; and to ensure that any party involved in the handling of drugs in the supply chain must have the ability to locate, quarantine and investigate any suspicious drug. "
"We are committed to staying at the forefront of new and emerging technologies and how they could be used to create safer, smarter and more reliable supply chains to better protect consumer safety and ensure the integrity of the high quality products they deserve.
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