Recent news
August 2011
Deal reached to inspect drugs made overseas
August 16, 2011 -- The US Government and the generic drug industry have reached an agreement that will lead to routine inspections of overseas pharmaceutical plants. According to the New York Times, the deal is almost certain to pass Congress and could transform the enormous global medicine trade. More than 80 percent of the active ingredients for drugs sold in the United States are made abroad, often at pharmaceutical plans rarely visited by inspectors.
Under the agreement, which is expected to be completed within weeks, generic drug companies—which make 75 percent of the prescription medicines sold in the United States—would pay $299 million in annual fees to underwrite inspections of foreign manufacturing plants every two years. At its present pace, the US Food and Drug Administration (FDA) would need more than 13 years to inspect every foreign drug plant exporting to the United States. FDA Commissioner Margaret Hamburg said that she is pleased with the generic drug fee proposals. “If a program along the lines of what the parties are working on is enacted by Congress, it would represent a real breakthrough,” she said, adding, “FDA’s entire generic drug program would be placed on a much more stable footing.” See the links below for more information.
