Of 58 new-drug announcements from FDA in 2012, 22 (38%) are cold chain products

In what it heralds as a new recent high, FDA approved 39 new molecular entities in 2012 (a total not matched since the mid-1990s)—encouraging news for an industry approaching the end of a “patent cliff” period where numerous blockbuster drugs have gone off-patent. But when those NME announcements are combined with new-indication announcements also made by FDA, and with the annual group of flu and other vaccines are added in, a surprising result appears: 38% of the new announcements are for cold chain drugs which need to be kept refrigerated at 2-8°C during storage and transportation.

Industry sources such as the 2012 HDMA Factbook (a compilation of both manufacturer and drug-wholesaler statistics) report that currently, 10% of stockkeeping units (SKUs) at wholesalers require refrigeration. Meanwhile, Pharmaceutical Commerce’s own Biopharma Cold Chain Sourcebook has been predicting that cold chain products will be increasing in proportion in coming years—and now, 2012’s result is a confirmation of that.

From a logistics perspective, however, a 38% cold-chain component does not translate into that proportion of all shipments requiring temperature control. Most cold chain products are specialty pharmaceuticals—and some are orphan drugs for rare diseases. On the other hand, seven of the 2012 announcements were for flu vaccine—a massive slug of product now passing through the pharma supply chain as this year’s flu season becomes an epidemic.

Looking through the label information of the various announcements, one can see an increased standardization of the label—but also some variations bound to create complexities for supply chain managers. Most controlled-room-temperature products now say the drug can be stored at 20-25°C, with excursions between 15 and 30°C. But some say the storage temperature is simply “25°C.” And while most cold-chain products are listed for 2-8°C storage, there was at least one this year (Thrombogenetics’ Jetrea [ocriplasmin]) that requires -4°C (frozen) storage. It’s also noteworthy how many of the newest oncology products are now tablets (almost always room temperature storage), which has implications not just for how they are shipped and stored, but also how they are dispensed to patients.