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Foreign drugs get little scrutiny by FDA

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  • Teresa Binstock
    Nov 1, 6:28 AM EDT Foreign drugs get little scrutiny by FDA By ANDREW BRIDGES Associated Press Writer http://hosted.ap.org/dynamic/stories/F/FDA_FOREIGN_DRUGS
    Message 1 of 1 , Nov 1, 2007
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      Nov 1, 6:28 AM EDT

      Foreign drugs get little scrutiny by FDA

      By ANDREW BRIDGES
      Associated Press Writer
      http://hosted.ap.org/dynamic/stories/F/FDA_FOREIGN_DRUGS
      ?SITE=CODER&SECTION=US&TEMPLATE=DEFAULT&CTIME=2007-11-01-06-28-37;


      WASHINGTON (AP) -- The Food and Drug Administration isn't paying enough
      attention to inspecting the growing amount of drugs produced by foreign
      manufacturers, say lawmakers who want the agency to update its approach.

      The head of the FDA is being called before a congressional committee
      Thursday to explain his agency's lopsided approach to inspecting drugs,
      both domestically and overseas.

      Members of the House Energy and Commerce subcommittee on oversight and
      investigations say the FDA's overwhelming emphasis on domestic inspections
      places the public at risk, as more and more drugs come from overseas.

      While nearly all U.S. drug makers are inspected at least once every two
      years, foreign manufacturers can go eight or more years between
      inspections, according to congressional investigators. While the domestic
      inspections are mandated by a law drawn up long before imports seized a
      sizable chunk of the drug market, there is no such requirement that the
      FDA conduct foreign inspections with any regularity.

      Prescription drugs and drug ingredients pour into the United States from
      an estimated 3,000 foreign companies, though the real number is unknown
      and could be as high as 6,700, congressional inspectors said in a memo to
      members of the subcommittee ahead of Thursday's hearing. Among those
      invited to testify: FDA commissioner Dr. Andrew von Eschenbach. The agency
      declined an interview request ahead of the hearing.

      The FDA plans to inspect just 300 foreign drug firms this year, announcing
      in advance its intent to do so each time. Of those inspections, most are
      of plants that make drugs awaiting FDA approval. Just 15 are of the type
      of periodic assessment meant to ensure a company's products remain safe in
      the years following FDA approval, though some pre-approval inspections
      also include some post-approval surveillance.

      In contrast, the FDA comes close to inspecting the roughly 3,300 domestic
      drug manufacturers once every two years as required.

      An estimated 80 percent of the active pharmaceutical ingredients used to
      make drugs sold in the U.S. are imported. Among finished drugs, an
      estimated 40 percent are made abroad.

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