Generic drugmakers are getting their ducks in a row on user fees. At the end of the month, generics firms sit down with FDA to start hammering out a potential user-fee agreement. So, aiming to pick up the pace of copycat drug approvals and speed plant inspections, the companies are meeting in advance to plan their approach to negotiations, the Wall Street Journal reports.
The Generic Pharmaceutical Association meets this week hoping to hammer out a user-fee plan. There's urgency in the air: some of the biggest brand-name drugs in history are coming off patent later this year and in 2012. "We must be able to move when those drugs come off patent," Mylan President Heather Bresch told the newspaper.
Branded drugmakers currently pay user fees to FDA under a program designed to move experimental drugs along. Generics makers don't pay, and the backlog of applications has been growing. Once opponents of user fees for their products, generics firms are reconsidering, and as the WSJ points out, many like the idea of combining inspections and approvals under the user fee banner. We'll see what sort of proposal they craft.
- read the WSJ piece