[Congressional Record Volume 154, Number 130 (Friday, August 1, 2008)]
[Extensions of Remarks]
[Page E1683]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




              THE ANIMAL DRUG USER FEE AMENDMENTS OF 2008

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                               speech of

                         HON. EDWARD J. MARKEY

                            of massachusetts

                    in the house of representatives

                        Wednesday, July 30, 2008

  Mr. MARKEY. Mr. Speaker, I rise in strong support of inclusion in 
this legislation of a technical fix to an important provision in the 
Federal Drug Administration Amendments, FDAAA, that I authored with 
Congressman Waxman.
  When the FDAAA was signed into law last September, it included a 
drafting error that had the effect of exempting medical devices from 
the requirement in the FDAAA that adverse events occurring during 
clinical trials must be reported to the registry and results data bank 
created by the bill.
  There is bipartisan agreement that this exemption resulted from a 
clerical error, not a deliberate change of policy. The data bank 
created by the bill is intended to provide patients with comprehensive 
information about clinical trials that are being conducted so they can 
consider enrolling in a trial and also learn about the benefits and 
problems associated with the drugs and medical devices that are being 
tested.
  The drafting error has the effect of only requiring drug companies to 
report medical problems that surface during clinical trials, exempting 
device companies.
  Everyone agrees that it was not the intent of Congress to exempt 
devices from reporting adverse events in their clinical trials. Both 
drug companies and device manufacturers were required to report to the 
database according to the agreement reached by Members on both sides of 
the aisle.
  I am pleased that this legislation fixes this clerical error.

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