U.S. Department of health and human services Secretary Kathleen Sebelius blocked today the plan B morning-after pill by hits shelves pharmacy, combat the recommendations from the U.S. food and drug administration.
“Today’s action reflects my conclusion that the data as part of the actual use study made available to and the label understanding study are not sufficient to expose plan B one-step for all girls 16 and younger without talking to a health care professional support,” Sebelius wrote in a statement.
FDA Commission Dr. Margaret Hamburg wrote in a statement that she believes there is sufficient and peace of mind is data that shows B step in a plan safe and effective for over-the-counter use for all women in the childbearing years – an opinion by the Sebelius.
“Because I don’t, that enough data have been presented to support the application think on plan B one-step for all girls in child bearing age make available over the counter, I get a FDA complete response letter the supplemental new drug application for authorisation (which) from Teva women’s health, Inc., to deny exhibition have set”, Sebelius wrote.
Approval by the FDA would that emergency contraception pharmacy shelves next to condoms, spermicides and contraceptive sponges landed. Instead women 17 and older the hormone can buy continue to high-dose pill over-the-counter trading, but girls younger than 17 must have a prescription.
Movement sparked outrage among some doctors who invented science say policy.
“Recommended the original FDA Advisory Committee, approval of plan B, was almost unanimous in its recommendation and not reason find you draw a line in the age of 18 or 17, or all,” said Dr. Paula Hillard, Professor of obstetrics and Gynecology at Stanford University School of medicine. “Sebelius and Obama should ashamed.”
Hillard, said that there no evidence of harm to young people and no medical reason, the plan B for young people to access to more difficult should be.
“In fact, since the national disgrace of the United States with the highest rates of adolescent pregnancy in the developed world, there are many reasons to make plan B for young people, more accessible”, she said.
Plan b or levonorgestrel, is a progestin-only emergency contraceptive that can prevent a fertilized egg from attaching to the wall of the uterus within 72 hours of unprotected sex. The drug is not effective if the woman is already pregnant, and a fetus throws it damage.
Teva pharmaceutical industries Ltd., the maker of plan B one-step, plan B no prescription status request in February, citing label understanding and security studies that show that women of all ages can the drug you take this product safely and effectively.
“Science has confirmed safely and effectively the drug with appropriate use.” The shift from prescription without prescription but requires that we have enough evidence to show that those who can this medicine understand the label for this product and use the product according to “Sebelius wrote.” “I don’t think that Teva meets the application of this standard.” “The name understanding and actual use contain no data for all ages, this product would be used for studies.”
The morning-after pill is a source of controversy for years. Susan Wood, Director who joined the Jacobs Institute of women’s health in Washington, D.C., its position as the Assistant FDA Commissioner for women’s health in 2005 after access to the pill to the Scientific Advisory Board strongly disagree with the FDA decision in over-the-counter trading it approved delay.
In 2008, the FDA decided that B in the open market could buy traded women 18 and older plan. A year later the Agency extended the regulation on the 17 and older.
“There a good reason for this has never been an age limit,” wood told ABC News in February. “It is a very safe product, and it is good that the FDA is considering it.”
B need plan wood, a young daughter in his teens and “blanches at the thought” of their features, support remains strong.
“I understand the nervousness,” she said. “It raises the specter of why do she need it?” “But the bad thing already happened, and the first step is to make sure that she is not pregnant and then later dealing with the other issues.”
But other groups staunchly protest to equate over-the-counter sales of plan b and some religious conservatives plan B to a pill abortion.
Wendy Wright, President who has group of conservative politics, concerned women for America, pronounced against the over-the-counter derivatives use of plan B in the past. She said that it improperly highly dosed for a pill to OTC, bearing in mind that regular birth control pills prescription are given only.
Wright is not against the prescribed birth control pills, she said that plan B “medical supervision needs.” “She could be pregnant they cause same Act concerning it to an hours”
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