[Congressional Record (Bound Edition), Volume 150 (2004), Part 12]
[Extensions of Remarks]
[Pages 16189-16190]
[From the U.S. Government Publishing Office, www.gpo.gov]




   AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND 
               RELATED AGENCIES APPROPRIATIONS ACT, 2005

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                               speech of

                           HON. JOHN SULLIVAN

                              of oklahoma

                    in the house of representatives

                         Tuesday, July 13, 2004

       The House in Committee of the Whole House on the State of 
     the Union had under consideration the bill (H.R. 4766) making 
     appropriations for Agriculture, Rural Development, Food and 
     Drug Administration and Related Agencies for the fiscal year 
     ending September 30, 2005, and for other purposes:

  Mr. SULLIVAN. Mr. Chairman, I would like to comment for the record 
regarding yesterday's passage of the Maloney Amendment to H.R. 4766, 
the Agriculture, Rural Development, Food and Drug Administration, and 
Related Agencies Appropriations Act, 2005.
  The Maloney amendment, which was adopted yesterday by the House by 
voice vote, stated that no funds may be used to keep a contraception 
drug as prescription-only if it has been determined to be safe and 
effective without a doctor's supervision. Let the record state that 
there is not an oral contraceptive that has been determined to be safe 
and effective without a doctor's supervision. Current law already

[[Page 16190]]

requires FDA to make products available over the-counter only when they 
are found to be safe and effective.
  On May 7, 2004, the FDA rejected an over-the-counter application from 
Barr Pharmaceuticals for the morning after pill because and I quote: 
``. . . we have concluded that you have not provided adequate data to 
support a conclusion that Plan B can be used safely by young adolescent 
women for emergency contraception without the professional supervision 
of a practitioner licensed by law to administer the drug.'' The 
petitioners for over-the-counter status could not prove that the drug 
was safe and effective without a doctor's supervision. It is important 
to note that the Maloney amendment has no effect on current law and 
merely restates current FDA law and policy regarding prescription drugs 
and over-the-counter drugs.
  I am concerned that my colleagues on the Democratic side of the aisle 
are attempting to use this amendment to chastise the FDA for its 
refusal to allow morning-after birth control pills to be sold without a 
doctor's prescription. I understand that the FDA is being lobbied 
heavily by the business community and social liberal groups for 
acceptance of Plan B and other over-the-counter pills that would seek 
to terminate a pregnancy. I'm encouraged that the FDA is willing to 
place the concerns of public health above other considerations and I am 
hopeful that the FDA will continue to resist pressure from these 
outside interests.

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