Could a nonprofit help with FDA's drug shortage list? It's complicated

A group of hospitals recently indicated they were going to come together and start manufacturing increasingly expensive off-patent drugs or those on FDA’s shortage list and offering them at cheaper prices. However, drugmakers can be slow to update aging infrastructure, creating shortages because of certain lapses.

A group of hospitals recently indicated they were going to come together and start manufacturing increasingly expensive off-patent drugs or those on FDA’s shortage list and offering them at cheaper prices. However, drugmakers can be slow to update aging infrastructure, creating shortages because of certain lapses. Gil Roth, founder and president of the Pharma & Biopharma Outsourcing Association, says: "If they're trying to become an ANDA [abbreviated new drug application]-holder (so that they'd be the license-holder for generics in shortage), they'd either have to pay to acquire such ANDAs or file them themselves." He notes that "filing their own would incur GDUFA [Generic Drug User Fee Act] filing costs for each one, and then they'd have the ANDA Holder Fee, starting the fiscal year after approval. They'd also have to build the infrastructure or hire consultants to ID and contract with API [active pharmaceutical ingredient] suppliers, source excipients, and either build their own Finished Dosage Form site or contract with a CDMO [contract development and manufacturing organization]." For some of the more complicated drugs to manufacture, like sterile injectables, it can be difficult to cut corners and manufacture more cheaply.