Registration fees for foreign firms?
This article was originally published in The Tan Sheet
Executive Summary
Sen. Chuck Grassley, R-Iowa, urges HHS and FDA to consider the feasibility of registration fees for foreign pharmaceutical drug manufacturers as a way to "augment the FDA's inspection resources and to limit the number of facilities that may register with the FDA without any intention of shipping products to the United States." In a March 11 letter, Grassley, who is ranking member on the Senate Finance Committee, also notes many foreign plants register with FDA as a means to "bolster their own standing and with no intention" of exporting products to the U.S. and this "bogs down the system." He says collecting fees from the estimated 3,000 foreign facilities currently registered with FDA would raise more than $5.1 million for inspections and would limit the number of foreign companies that register. "This amounts to about a 40 percent increase for FDA's current foreign inspection budget of roughly $12.7 million," he says. The senator asks for a written response "as soon as possible" as well as a briefing from HHS/FDA...