Sunday, January 27, 2013

Generic Drug User Fee Act (GDUFA) - What will be the implications for the consumer & for the generic API manufacturers based outside NA & EU

20 August, 2011
Posted in Linkedin Answers by Murali Apparaju

For those who remember SOCMA & EFCG making a fervent pitch in 2006 for a level playing field for domestic (read: NA/ EU) and foreign (read India, China) API manufacturers, this is an announcement of their first success & how.....

Two days ago, GPhA, EFCG & SOCMA reached an agreement with US FDA on the proposed final form of the Generic Drug User Fee Act (GDUFA).

While at the conceptual level this act is for higher patient safety through a tighter regulation of Ingredient manufacturer, this also appears to be an apparent back-door strategy to wall-out "old-technology" (read: "No QbD/ PAT" also read: "Cheap") Indian & Chinese API manufacturers in favor of the more-regulated, domestic, safe & costlier? local manufacturers.
(the NY times brief in the above link is titled "A deal to get Cheaper & Safer drugs" - wonder how exactly was this deduced?!)

What do you think GDUFA will eventually achieve/ cause & do you think consumer is the real beneficiary?

Hoping to see some comments here.

Murali Apparaju