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Will FDA deliver a turkey on Nov. 27?
There are people watching minute by minute for FDA to issue the Congressionally mandated guidelines for providing traceability information between pharma manufacturers and their trading partners; the Nov. 27 date was set at one year following the passage of the Drug Quality and Security Act, part of which is the Drug Supply Chain Security Act (DSCSA). DSCSA sets a national standard for exchanging “traceability” information that would track pharma shipments, at the lot level, through the drug supply chain; on Jan. 1, the first stage in this, exchanging certain transaction information with immediate trading partners, is due to take effect. (Retailers have until mid-2015 to have this documentation on hand.)
Thus, the tight deadlines and the scramble to get systems in place. Meanwhile, TraceLink (Woburn, MA), one of a handful of companies developing traceability tools for life sciences, has announced that over 50,000 manufacturers, distributors, repackagers and others have already signed on to its “Life Sciences Cloud,” a cloud-based interface for exchanging DSCSA information (as well as potentially other types of trading information). A couple weeks previously, it announced a “one-week compliance solution”—getting a client up and running in its cloud in five days or less.
"With more than 50,000 members today and tens of thousands more being added in the coming weeks, TraceLink has become the de facto national track-and-trace network for Life Sciences,” asserts Brian Dalaiden, VP marketing at the firm. “Today, the industry is focused on lot-level data exchange for initial DSCSA regulations. As the industry accelerates its preparation for serialization deadlines for 2017 and beyond, TraceLink is perfectly positioned to become the core serialization data-exchange network using the same connections."
Having a TraceLink account is probably a good thing, but there still needs to be IT resources dedicated to what information is posted and how it is accessed; TraceLink has its methods for setting this up, but so do other traceability IT vendors.
One of the inherent advantages of how TraceLink is set up is that once an organization is onboard, it has the pathway to link to any other organization; no need to have separate accounts for each and every trading partner—just agreed-on rules for engagement. Potentially, then, TraceLink could become not just the network, but even the repository of traceability information for the industry. Organizations that have worked on full-bore traceability have found that it takes massive data-storage resources, but that’s the beauty of the cloud, where data storage and processing are dialed up as needed, at relatively low costs. Several European nations, notably Turkey, have set up national data repositories; Germany has indicated it will do the same as Europe aligns with its own drug-authentication scheme.
Does this put all the eggs in the basket of one not-too-large company? Possibly; but the dramatic changes in business practices wrought by the Web have been dealing with issues like this for quite a while. Ebay, the online store, has 149 million "active buyers," according to the company; Facebook has 1.35 billion users--roughly one out of five human beings on the planet. In the healthcare arena, there are dominant data collectors/transactors such as IMS Health (for prescription sales data); Relay Health (for pharmacy price adjudication) or Surescripts (for e-prescribing). Ech has competitors in its space, but a majority of clients use their services, alone or with other providers.