Generics makers step up for shortages response

Tools

The FDA is "not necessarily the best organization to provide notification on shortages," Ralph Neas told Reuters last week, amid a seeming riot of actions and announcements targeting the prevention of drug shortages [see related story]. The Generic Pharmaceutical Association's (GPhA) CEO said the agency lacks "the analytical background with respect to the private sector."  

GPhA is stepping up with the proposal of a multi-stakeholder initiative to "accelerate the recovery of critical drugs in short supply," according to a statement. The Accelerated Recovery Initiative (ARI) will rely on voluntary communication between a yet-unnamed independent third party and members of the generics supply chain: manufacturers, wholesalers, distributors, purchasers and the FDA.

As envisioned, an ARI SWAT team comprising members from FDA and generics makers will be deployed for quick response to shortages, working with the FDA drug shortage staff. ARI will supplement "the excellent work currently being done by the FDA to expedite regulatory reviews and work closely with manufacturers," according the GPhA statement.

An FDA deputy director said the agency will review the GPhA proposal carefully, according to the Reuters report.

- see the GPhA release
- here's the Reuters story

Related Articles:
Drugmakers respond to shortages order, HHS report

Manufacturing-savvy generic cos. set for business boost
Shortages highlight supply chain communications problem
Expert: FDA strategy document lacking in detail
Hamburg pushes science, enforcement in FDA strategy