Half of 2017 FDA drug approvals are cold-chain products
The appearance of deep-frozen products will complicate distribution practices
There were 57 new drug approvals (including one vaccine) issued by FDA in 2017—more than double the total in 2016, and representing a high not seen since the mid-2000s.* Pharmaceutical Commerce has gone through the official labels (package inserts) for these drugs, finding that just under half—28 of the 57, or 49%—are temperature-sensitive products, with 23 requiring refrigeration (2-8°C) storage and transportation. An additional five products require below-zero or cryogenic temperatures.
Those cryo products represent their own challenges for logistics providers, who, generally, try to have standardized practices for the temperature ranges they operate under. One product—Grifols’ Fibrin Sealant—requires storage at -18°C (0°F); another (Biomarin’s Brineura) requires a -35 to -15°C regime. There are three cellular/gene therapies approved, and all three have different temperature specifications: Spark Therapeutics’ Luxturna (-65°); Novartis’ Kymriah (-120°C, which is liquid nitrogen vapor); Kite Pharma’s Yescarta (-150°C, which is closer to liquid nitrogen). This situation speaks to a custom, bespoke service for each drug. These aren't the very first products commercialized requiring cryogenic service (many bio samples in clinical trials require deep freezing in transit, as well as some tissue products which are technically medical devices). And it is worth emphasizing that the other 23 cold-chain products need to be kept unfrozen for them to retain efficacy.
Most of the non-cold-chain products are using the USP guidance on storage: 20-25°C, with excursions of varying lengths between 15-30°C. But some specify a 2-25°C range, and one is simply “up to 30°C,” but not frozen.
In its annual Biopharma Cold Chain Sourcebook, Pharmaceutical Commerce estimates the global volume of 2017 cold chain products at $283 billion, out of a total market of $1.17 trillion, and growing at approximately twice the rate of the overall pharma market.
*We missed the approval of Spark Therapeutics’ Luxturna in an earlier report; this brings the 2017 total to 57.
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.
