Mylan’s President Recommends the FDA Should Update User Fees for Generic Drug Companies & Beef Up Inspection Efforts
Posted Feb 16 2011 8:57pm
She does make some very good points here with bringing in additional revenue to allow the FDA to inspect more over seas manufacturing facilities. She also states that branded companies as well as generic drug companies both need need more attention with inspections. Currently in the US factories are on a 2 year cycle and she stated the same should be done overseas. BD
Bresch wants the agency to start inspecting drug facilities located overseas — for branded companies as well as generic makers — on the same two-year cycle is uses to review most plants in the U.S.
About half the drugs in America, both branded and generic, are imported, and many are coming in from foreign plants that may never have been inspected, Bresch says. “You’re giving those drugs to your children,” she says. “Don’t you want to know that they were made in safe conditions?”
Bresch is taking her campaign to the GPA’s meeting, which begins today, where members on various strategy committees are trying to hammer out a position on user fees in time for upcoming negotiations with the FDA. Her plan isn’t the only one in play, but several association members said the group is coalescing around her general ideas.