“Unacceptable”: Prominent U.S. Senators Demand FDA Provide Names of Troubled Foreign Drugmakers Skirting Import Bans
by Debbie Cenziper and Megan Rose, ProPublica, and Katherine Dailey, Medill Investigative Lab
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Two prominent U.S. senators are demanding the Food and Drug Administration provide an immediate accounting of the foreign generic drugmakers allowed to skirt bans meant to keep dangerous medication out of the United States.
The top members of the Senate Special Committee on Aging cited a recent ProPublica investigation that exposed how the FDA quietly awarded special passes to troubled manufacturers so they could continue shipping medication to Americans even after the agency barred their factories because of serious quality concerns.
“These exemptions undermine the goals of U.S. policy, threaten the safety of drugs, and place Americans’ health at risk,” the senators wrote in a bipartisan letter to FDA Commissioner Marty Makary.
Committee Chair Rick Scott, R-Fla., and ranking member Kirsten Gillibrand, D-N.Y., described “urgent concerns” about the FDA’s oversight of foreign drugmakers and whether medication coming into the United States was safe.
ProPublica found the agency granted exemptions from import bans to more than 20 foreign factories since 2013, including © ProPublica
