If you live in the US, it’s seriali“z”ation. Regardless of how you spell it, track-and-trace is coming. The Drug Supply Chain Security Act train, while delayed a bit, is still thundering down the track (pun intended). You know who hates serialisation? Smaller CMOs. Implementing serialization is expensive and without a massive number of customers over which to spread the cost, some smaller CMOs could be in a world of hurt. According to Tracelink, as many as 400 CMOs will not be ready for upcoming US and EU track-and-trace regulations. And if you can’t afford to be compliant, then perhaps the next step is to consolidate. Looks like this trend is far from over. So, buckle-up sippy cup, get your CMO strategy in line, and enjoy the roller coaster ride.
A recent NY Times op-ed piece and a corresponding Letter to the Editor talk about how importing generic drugs might lower healthcare costs in the US and stop what the op-ed writer perceives as price gouging. The op-ed position: just do it. The letter to the editor position: not so fast. Relationship status: it’s complicated. There are obvious concerns about drug safety and the US is making strides in protecting the drug supply with its track and trace efforts. That said, the letter to the editor proposed an interesting idea: “…speedily approve any sound generic drug application from a nonprofit entity for a drug whose price has risen sharply.” That’s one idea, but why just from nonprofits? Come on, people. More ideas required! Have an opinion on this? Participate in this week’s FastPoll™ below.