The FDA and generic drug makers have reached a deal that would raise nearly $300 million in annual fees to inspect foreign API makers and bring monitoring in line with domestic inspection rates. According to the New York Times, the agreement awaits some final specifics and is “almost certain to pass Congress” as part of the PDUFA 5 reauthorization, due up next year.
Under the outlines of the deal, as reported by the Times and Pittsburgh Tribune-Review, generic drug makers would pay $299 million annually so that the FDA can conduct inspections of foreign drug plants at the same rate – every two years—that it does domestic ones.
“If a program along the lines of what the parties are working on is enacted by Congress, it would represent a real breakthrough,” FDA Commissioner Margaret Hamburg told the Times. “FDA’s entire generic drug program would be placed on a much more stable footing.”
To those around the industry, the deal seems an important solution to a (sadly) familiar equation: that even as its demands of the FDA grow, Congress is unlikely to fund the agency sufficiently to meet its increasingly global inspection lode. In fact, lawmakers have been threatening to cut funding, and in the current political climate, the agency may find itself turning to industry for help maintaining current operations (as its user-fee program does now for approvals.)
Heather Bresch, President of generic drug maker Mylan, is credited with getting the deal this far, and has been an outspoken advocate in the industry for the fees and the parity they’re designed to bring. She told the Tribune-Review that “the rigor is just not there (at foreign manufacturing plants) as it is here in the United States.”
“As a mother of four children, I want to know the drugs I’m giving them are safe,” Bresch told the Times. “And as an American businesswoman, I want to keep jobs here, and that means making sure foreign drug plants have to meet the same standards as domestic ones.”
–Kate Petersen, PostScript blogger