The Drug Supply Chain Security Act (DSCSA) of 2013 specified that FDA should both hold public hearings to gather industry commentary on how the program is to be implemented, and to organize pilot projects to demonstrate the feasibility of industry solutions to meet the regulatory requirements. In theory, a pilot would have occurred before companies start installing equipment and IT systems, but today, most of the marking and coding equipment for packages is already up and running. Interconnected IT systems, however, are still a vision rather than a reality. So, there’s certainly value yet to be obtained from FDA’s call for participants in one or more pilots of a multi-party data-sharing system.
In an about-to-be published notice, FDA is inviting companies to propose pilot projects; the notice specifies a 30-day period from when it is officially published in the Federal Register (which probably means an early March deadline for submissions). Participation is voluntary and, as the notice reads, “The participant will be responsible for the funding and resources necessary to conduct the pilot project, and for determining each partner’s role and responsibility in its pilot project.” Presumably, IT vendors and consultants, eager to demonstrate their capabilities, will pull in some of their pharma clients to set up pilots. Wholesalers, led by the Healthcare Distribution Alliance, have been very active in developing workable solutions to meet their requirements (which implies other capabilities both up and down the supply chain.) Also, the DSCSA language is explicit on setting up processes that enable small supply-chain entities (e.g., some independent pharmacies) to be able to demo’d as well. All that being said, getting a good cross section of the pharma supply chain will be a challenge.
In a lengthy press release issued on Feb. 7, FDA Commissioner Scott Gottlieb emphasized DSCSA’s rationale for protecting against the introduction of counterfeit products: “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,” he stated. While counterfeit prevention is the ostensible purpose of DSCSA as the law was written, industry managers are banking on other business values to be obtained, starting with better inventory control in the supply chain. Elsewhere, the news release references preventing diversion of drug shipments (which is another potentially valuable objective); and also FDA’s interest in adopting blockchain technology to food and pharma traceability.
The European Union, in accordance with its Falsifled Medicines Directive (roughly comparable in intent to the US’ DSCSA) has a go-live date of February 9 for product marketers to upload serialization data of their products to a pan-Euopean hub, which in turn is connected to national for EU member states. On Feb. 5, the European Medicines Verification Organization (EMVO) announced that Malta has become the 28th EU member with a national data system in place. EMVO’s website also posts a count of 1,790 marketing authorization holders have registered in the EU system, but this is less than the full number of companies marketing products in the region.