...[Oversight and Investigation] subcommittee member Rep. Michael Burgess (R-TX) emphasized their view that FDA should be compelled to do a pre-inspection prior to approving a new active pharmaceutical ingredient supplier abroad. This is currently not mandated in law, but represents a long-standing FDA policy. FDA has admitted it did not inspect the Chinese producer of Heparin ingredients linked to its contamination... ***this full article is not available Read more

Note: When you click "more" you will be directed from Rep. Burgess' website to the publication's site ...U.S. Rep. Michael Burgess agrees. The Texas Republican sits on a health committee that oversees the FDA. "That is the government agency that should be looking into this," Burgess said. "They are responsible, not just for devices themselves, but the products that go into making the device."...more ***be sure to watch the video Read more

Note: When you click "more" you will be directed from Rep. Burgess' website to the publication's site. ..."You do have to wonder, is this an unscrupulous merchant with his thumb on the scale? Or is it someone who is intent on doing us harm?" asked Rep. Michael Burgess (R-Texas). Burgess said companies sometimes hesitate to point out troubles in their supply chain for fear of putting themselves at a competitive disadvantage. "The FDA needs to make a requirement that they be forthcoming, lest we g... Read more