Tuesday, August 8, 2006

The maker of the Plan B “morning-after pill” says that within two weeks, it will submit an amended petition to sell the emergency contraception without a prescription.

The announcement from Barr Pharmaceuticals Inc., comes after a “very productive” meeting yesterday with U.S. Food and Drug Administration officials, who promised a “quick” response.

Last week, the FDA surprised many by seeking a prompt meeting with Barr to discuss over-the-counter sales of the pill to women 18 years and older.

Barr previously had been asking the federal agency to permit nonprescription sales of Plan B to women 16 years and older in what became a three-year-long tug of war involving abortion politics.

Carol Cox, Barr spokeswoman, declined to state publicly yesterday the minimum age that the company will be requesting for those purchasing Plan B without a prescription.

But of the older age requirement sought by the FDA, Ms. Cox said, “These are all issues we can work through.”

Attempts to get a response from the FDA were not successful.

Wendy Wright, president of Concerned Women for America, said she was shocked to learn that new regulations for sales of Plan B without the need for a doctor’s prescription seem to be moving ahead so quickly.

“This is a silly proposal … because the person who buys the drug may not be the one who takes it,” she said.

She said it doesn’t make sense that a high dose of a drug is being approved for sale without a prescription, when there are tight medical restrictions on prescription sales of a lower-dose version of the same drug, known as the birth-control pill.

Plan B is a combination of two pills that can prevent pregnancy if taken within 72 hours of sexual intercourse.

It has been available for use as an emergency contraceptive by prescription since the FDA approved it in July 1999. In 2003, new applications to sell the drug over-the-counter were filed and Barr acquired the drug in October of that year.

In December 2003, an FDA advisory panel voted 23-4 to recommend that Plan B be sold over-the-counter to those of all ages.

The next spring, the FDA rejected that recommendation, expressing concern about young teens using the drug. In July 2004, Barr reapplied, asking that girls 16 and older be allowed to use it without a prescription.

Conservative parents and birth-control advocates have long disagreed over the desirability of Plan B, but the debate became more heated in April 2005, when two Democratic senators — Hillary Rodham Clinton of New York and Patty Murray of Washington — said they would block Lester Crawford’s nomination as FDA commissioner until the agency issued a decision on Plan B.

The senators lifted their hold on Mr. Crawford, who was later confirmed, after Secretary of Health and Human Services Michael O. Leavitt promised an FDA decision on Plan B would be made by Sept. 1, 2005.

But in August 2005, the FDA delayed action indefinitely, saying it needed to write rules on enforcing proposed age restrictions. Mr. Crawford resigned a month later.

In March, Mrs. Clinton and Mrs. Murray blocked the confirmation of Dr. Andrew von Eschenbach to replace Mr. Crawford as FDA commissioner, pending a decision on Plan B.

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