FDA approved 45 new drugs in 2015 – a new recent record – 15 are cold chain products
It’s a great way to start the New Year: FDA’s Center for Drug Evaluation and Research (CDER) reports 45 “novel new drugs” were approved in 2015, up from 2014’s 41, and representing a new high not seen since the mid-1990s. The drug-approvals count is fraught with conflicting perspectives: some feel that FDA puts too many obstacles in front of approvals; and some are concerned that the more streamlined orphan-drug pathway is being abused. Nevertheless, FDA uses the occasion for some chest-thumping: nearly two-thirds of the approvals (29 of the 45) were first-in-the-world.
For those concerned with the safe storage and transportation of drugs, it’s worth noting that 15 of the 45 approvals are for cold chain products, usually requiring refrigerated (2-8°C) conditions. Pharmaceutical Commerce, in its annual Biopharma Cold Chain Sourcebook, notes that the dollar volume of cold chain products is growing at twice the rate of all pharma products. A 2015 approvals list from the Center for Biologics Evaluation and Research CBER) includes 12 new drugs (derived from blood products) and vaccines; of those, 11 require cold chain handling.
Source: Pharmaceutical Commerce