U.S. inspections of overseas pharmaceutical plants would increase and regulators would gain new recall power under proposals unveiled by Democrats in the U.S. House of Representatives on Monday.
Representatives Henry Waxman, Frank Pallone, John Dingell and Bart Stupak said they released the measures to open discussion on ways to help the Food and Drug Administration better police the increasingly global marketplace for prescription drugs.
The draft legislation is a response in part to tainted heparin from China blamed for dozens of deaths in 2008.
“Americans have been alarmed in recent years over some very concerning issues related to the quality and safety of certain drug products. We know we need to address this. The only question now is how,” Dingell said in a statement.
The draft legislation would require “parity” between inspections of foreign and domestic drug manufacturing plants. Now, overseas production sites are inspected much less often than U.S.-based facilities.
It also would require that manufacturers “ensure the safety of their supply chain” and would give the FDA power to mandate recalls of unsafe medicines.
The Democratic lawmakers said their proposal “reflects the reasoned priorities and recommendations of” the FDA.
Waxman, chairman of the House Energy and Commerce Committee, said he would work with the FDA “and all stakeholders to move this legislation forward as soon as possible.” But time for action in the current Congress is running short ahead of the November elections.
With no initial Republican supporters, the measure’s fate is unclear if Republicans take control of the House next year.
Concerns about the quality of medicines heightened in 2008 when dozens of deaths were blamed on contaminated ingredients from China used in Baxter International Inc’s blood-thinner heparin.
(Reporting by Lisa Richwine; Editing by Gary Hill)
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