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Comment Period Ends; No Action Yet on Plan B

The Food and Drug Administration’s (FDA) 60-day comment period on the emergency contraceptive Plan B ended on Tuesday, but the FDA has not taken further action. Estimates place the number of comments received around 10,000, and FDA spokesperson Julie Zawisza said the agency will “read them all and decide how to proceed,” reports the Washington Post.

Senator Hillary Rodham Clinton (D-NY) said of the delays over Plan B, “They know that a decision based on science would be an approval, but they have political allies that don’t want to see that happen,” the Post reports. Clinton and Senator Patty Murray (D-WA) also presented a petition with nearly 10,000 signatures supporting immediate approval. “The FDA should make their decision based on science and efficacy, not on public pressure,” Murray said, reports the Associated Press. One positive to come out of the repeated delay has been increased awareness of emergency contraception, according to Princeton University economist James Trussell, who told the Philadelphia Inquirer, “It has generated a ton of publicity, and that almost surely has a consequence of increasing awareness – and awareness is still the biggest barrier to use.”

Emergency contraception is exceedingly safe and effective if taken within 5 days but it is most effective (95 percent) if taken within 24 hours after any unprotected sexual intercourse, when a condom breaks, or after a sexual assault. EC has the potential to cut in half the 3 million unintended pregnancies in the United States each year and prevent thousands of abortions a year.

Sources:

Associated Press 11/1/05; Philadelphia Inquirer 11/1/05; Washington Post 11/2/05

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