THE ANIMAL DRUG USER FEE AMENDMENTS OF 2008 -- (Extensions of Remarks - August 01, 2008)
HON. EDWARD J. MARKEY
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.