In the year since it was approved for over-the-counter sales, the morning-after pill has become a huge commercial success for its manufacturer, but its popularity and solid safety record have not deterred critics from seeking to overturn the milestone ruling.
The anti-pregnancy pill, marketed by Barr Pharmaceuticals Inc. as Plan B, was the focus of bitter debate for three years. After repeated delays, the US Food and Drug Administration (FDA) declared on August 24, 2006, that customers 18-years and older should be able to buy it in pharmacies without a prescription.
Barr began distributing the over-the-counter version last November, and all national pharmacy chains now stock it. The company projects that sales of Plan B will total about $80 million for 2007.
"Overall, we've been very pleased with the acceptance," said Barr spokeswoman Carol Cox. "The product may not be for everyone - but if you find yourself in a position to need it, it should be available."
Controversy over FDA ruling
Despite the booming sales, and evidence that the pill is safe if properly used, critics remain active.
A coalition of conservative groups, including the Family Research Council and Concerned Women for America, has filed a lawsuit in federal court seeking to reverse the FDA ruling. The groups contend that the FDA acted unwisely under political pressure and lacked authority to approve the same drug for both over-the-counter and prescription-only distribution based on the user's age.
Barr says Plan B, a high dose of a drug found in many regular birth-control pills, can lower the risk of pregnancy by up to 89 percent if taken within 72 hours of unprotected sex.
During three years of FDA deliberations over Plan B, many claims were made about it. Supporters said it would reduce the number of unintended pregnancies and abortions; opponents said it would fuel teenage promiscuity because girls under 18 could obtain it from an older person -male or female - buying it over-the-counter on their behalf.
Thus far, there have been several studies casting doubt on all these claims - although activists of varying views say there is a shortage of authoritative research. Cecile Richards, president of the Planned Parenthood Federation of America, believes Plan B will contribute to a measurable drop in unintended pregnancies once accurate information about it spreads widely among American women. – (Sapa)
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