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Clinton, Senators Seek Report, Hearing on `Morning-After' Pill

By Kerry Dooley Young

Sept. 2 (Bloomberg) -- U.S. Senator Hillary Clinton and 12 colleagues asked Congress's investigative arm to release a report on why regulators have delayed deciding on over-the-counter sales of the ``morning-after'' emergency contraceptive.

The legislators today also said in an e-mailed statement that they want a Senate hearing about how the Food and Drug Administration has delayed making a decision on ending the prescription requirement for Barr Pharmaceuticals Inc.'s Plan B. The senators, all Democrats except for one independent, asked the Government Accountability Office to conclude an investigation that they requested June 15, 2004.

``Yours is the only independent investigation under way on this important matter of women's health, and it has the potential to shed much-needed light on the FDA's actions,'' said the letter, signed also by Patty Murray of Washington. ``We hope you will finish your work in the near future to allow policy makers and the public gain a full understanding of the FDA's process.''

Barr has been trying for two years to win FDA approval of over-the-counter sales of Plan B, which the FDA says is intended to prevent pregnancies and won't end them. Supporters of Barr's applications, such as the American Medical Association, say over-the-counter sales of Plan B will prevent pregnancies. Opponents have said they think the pill causes abortions.

Revised Application

The FDA rejected Barr's original application last year. Barr then revised it to address concerns about teenagers using Plan B, leaving the prescription requirement in place for people 15 and younger. The FDA has delayed since January making a decision on this application, and on Aug. 26, said it would need to send the revised application out for a two-month public comment period.

Other signers of the letter to the GAO were Democrats Barbara Boxer of California, Maria Cantwell of Washington, Jon Corzine of New Jersey, Christopher Dodd of Connecticut, Mark Dayton of Minnesota, Tom Harkin of Iowa, Daniel Inouye of Hawaii, Edward Kennedy of Massachusetts, Charles Schumer of New York, and Debbie Stabenow of Michigan, and independent James Jeffords of Vermont.

Barr shares rose 37 cents, or less than a percent, to $45.76 as of 12:55 p.m. in New York Stock Exchange composite trading.

To contact the reporter on this story: Kerry Dooley Young in Washington kdooley@bloomberg.net

Last Updated: September 2, 2005 13:22 EDT

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