AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND RELATED AGENCIES APPROPRIATIONS ACT, 2005 -- (House of Representatives - July 13, 2004)
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Mr. SMITH of New Jersey. I thank the gentleman for yielding me this time.
First, I want to thank my friend for clarifying that the pending amendment is simply a restatement of current law. I appreciate the fact that he has made that very clear.
I want to make a point so that we are also clear about the FDA's decision concerning Plan B. Dr. Stephen Galson, the acting director for FDA's Center For Drug Evaluation and Research, stated in a letter that based on science and safety concerns, Plan B will not be sold over-the-counter and this is his quote: "Based on the review of the data, we have concluded that you (Barr Research Inc) have not provided adequate data to support a conclusion that Plan B can be used safely for young adolescent women."
He also goes on to point out that "only 29 of the 585 subjects enrolled in the study were 14 to 16 years of age, and none were under the age of 14." So based on science and safety concerns, the recommendation was made that Plan B should not be approved for over-the-counter sales.
So this restatement of current law does not add nor detract from things as they are.