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Tue May 22, 2012
Rep. Dingell supports bill to speed up FDA reviews
Congress is trying to speed up the review process for new medicines and devices while still keeping them safe. A bill before the House would increase the amount of money and authority given to the Food and Drug Administration to do that.
Congressman John Dingell represents Michigan's 15th District and supports the bill. He says one way the new bill will protect the drug supply is by increasing the FDA's authority over imported medicine.
"[The User Fee bill] enables [the] Food and Drug [Administration] to address the problems that we had (i.e. unsafe pharmaceuticals and unsafe commodities and components for the manufacture of pharmaceuticals in this country," Dingell said. "So Food and Drug can control them now."
Drug and medical device manufacturers typically pay user fees that fund the reviews by the Food and Drug Administration. The new bill will expand those fees to more companies, including international ones.
"This is the best way of leveling the playing field between American manufacturers and foreign manufacturers" said Dingell, "and also seeing to it that everybody -- consumers, manufacturers and all get the services that they're entitled to from [the] Food and Drug [Administration]."
Patient safety advocates are against parts of the bill. They say even tougher reviews should be applied to medical devices.
-Nishant Sekaran, Michigan Radio Newsroom