The past month or so has been an active one for followers of the never-ending track-and-trace debate in the industry. Following an FDA workshop in mid-February, the topic was front-and-center at March’s HDMA Distribution Conference (as it has been for several years). A few days later, a meeting was organized by the Pew Prescription Project, an activity within the Pew Charitable Trusts public-policy organization. There was a session at the Parenteral Drug Assn.’s annual Cold Chain Conference, where folks are usually talking about temperature sensors and air-cargo routes. In the next few months, there are going to be meetings held by various public and private organizations on in-transit security of pharma shipments; anti-counterfeiting technologies for pharmaceutical packaging; and retail supply-chain management (see listings on p. 31). Across the pond, the European Parliament has moved a set of rules for pharmaceutical distribution forward; this will put additional emphasis on tracking pharma products as well.
Despite all this deliberating, there has been no starter gun being fired to give the US industry an action plan and a deadline. As has been the case since 2008, developments are moving ahead faster outside the US than inside it (see p. 8). In Washington, track-and-trace is becoming a part of national security, both of human health and of intellectual property.
Meanwhile, we’re also tracking the uptake of the Apple iPad and similar tablet devices (see p. 24 for some valuable advice on this point). There are reports of thousands of these devices being purchased by pharma companies, primarily for their sales/marketing staffs and medical science liaisons. I’m not critical of that—hey, I’m as excited about the next guy about these capabilities. I would wager, though, if the dollar figures of investment in these devices were matched against current industry investment in track-and-trace, iPad, and the content development, training and resources attached to it, would win. As the very insightful Ernst & Young Progressions report outlines (p. 8), there are hundreds of social media and related projects going on in the industry today, and that’s just the beginning.
The common element to both of these is data, and from that, intelligence. Intelligence about product movement, about prescriber patterns, about patient outcomes. So, I ask, why is intelligence about rep-physician or manufacturer-customer interactions more valuable than about product movement through the supply chain? Why is it so easy to justify the next new thing in personal computing devices, and so hard to justify safer, more efficient and more profitable supply chains?
The implication is that over time, the bio/pharma industry will become better at selling product than it is at making and distributing it. One worrisome sign has been the jump in product recalls in 2010, up anywhere from 33 to 100%, depending on who’s doing the counting. Another is the increase in drug shortages seen in the past several years—bad enough that hospital pharmacists, for one, have been holding seminars on the topic. The point I would stress, though, is that investing in better supply chain operations is an investment in better marketing—these are tightly interconnected functions in well-run manufacturers. So, how about a snazzy new iPad, and some hot apps, for the supply chain managers?
Understanding the FDA's Exemption for DSCSA Compliance
November 12th 2024In the quest for achieving full traceability, the exemption applies to certain trading partners under the Act, and postpones enforcement of final compliance requirements while acknowledging progress and ongoing challenges.