FDA Approves Sale of Plan B Morning After Pill to Teenagers
by Steven Ertelt | Washington, DC | LifeNews.com | 4/30/13 5:53 PM
The FDA made it official today saying the morning after pill known as Plan B should be available without a prescription for teenagers starting at age 15.
“Plan B One-Step will not stop a pregnancy when a woman is already pregnant, and there is no medical evidence that the product will harm a developing fetus,” the FDA said in a statement.
Some pro-life groups have pointed to comments from the maker of the drug and studies to show that the morning after pill can act as an abortion agent in some cases, terminating the life of a unique human being hours after conception.
Previously, the Plan B morning after pill was only available over the counter to women above the age of 17. The Food and Drug Administration sought to make the drug available more widely but Health and Human Services Secretary Kathleen Sebelius overruled the decision.
Eventually a court sided against the Obama administration, prompting the FDA to move ahead.
“Research has shown that access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States,” FDA Commissioner Margaret Hamburg said. “The data reviewed by the agency demonstrated that women 15 years of age and older were able to understand how Plan B One-Step works, how to use it properly, and that it does not prevent the transmission of a sexually transmitted disease.”
The Planned Parenthood abortion business quickly hailed the decision, with its president Cecile Richards tweeting, “Good news!”
Judge Edward Korman, a federal judge based in New York City, heard arguments in a case filed by the pro-abortion Center for Reproductive Rights over whether the FDA should have ultimately allowed teens to buy the Plan B drug without a doctor’s order. The pro-abortion group says such drugs are being held to a different standard than other drugs and that decisions are not based on science, but on politics.
The Obama administration is considering whether to appeal the decision and has five more days to decide.
The lawsuit was filed prior to the decision by the Obama administration in December 2011 to not allow sale of the morning after pill to teens.
During the hearing, Korman was highly critical of the government’s handling of the issue when he ordered the FDA in 2009 to let 17-year-olds obtain the medication. At the time, he accused the government of letting “political considerations, delays and implausible justifications for decision-making” cloud the approval process.”’
In comments to LifeNews, the Family Research Council slammed the decision.
Anna Higgins, J.D., director of the Center for Human Dignity at the Family Research Council, expressed serious concerns regarding a federal judge’s order today that the “morning-after” pill be available to girls of all ages without a prescription.
“This ruling places the health of young girls at risk. Making Plan B available for girls under the age of 17 without a prescription flies in the face of medical information and sound judgment. I am very troubled that the court has not fully taken into account the concerns expressed by HHS Secretary Kathleen Sebelius and many public health advocates that there is not enough data on the health effects of Plan B on young girls,” she said.
“According to the new numbers released by the Centers for Disease Control, there were 19,700,000 new STIs reported in 2008 – the last year for which numbers are available. Based on the CDC’s estimates, that brings the total number of STIs in the U.S. to just over 110 million. Most of the new cases crop up in young men and women aged 15-25. Making Plan B available over-the-counter for any age will put many of these young girls at further risk because it circumvents necessary medical screening for sexually active girls,” she told LifeNews.
“There is a real danger that Plan B may be given to young girls, under coercion or without their consent. The involvement of parents and medical professionals act as a safeguard for these young girls. However, today’s ruling removes these commonsense protections,” concluded Higgins.
The FDA originally approved the morning after pill at the end of the Clinton administration in 1999 and, in 2006, it was approved for nonprescription use for women 18 and older. Previously, a federal court ordered the Food and Drug Administration to reconsider its decision preventing minors from purchasing the morning after pill without a prescription.
However, Sebelius said there was not enough information on how the drug affects teens to make the decision. She overturned a ruling by Food and Drug Administrator Margaret Hamburg to allow teens to purchase the morning after pill without a doctor’s involvement, even though the drug may cause an early abortion in some cases.
In a statement concerning her decision, Sebelius said, “The average age of the onset of menstruation for girls in the United States is 12.4 years. However, about ten percent of girls are physically capable of bearing children by 11.1 years of age. It is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age. If the application were approved, the product would be available, without prescription, for all girls of reproductive age.”
“Because I do not believe enough data were presented to support the application to make Plan B One-Step available over the counter for all girls of reproductive age, I have directed FDA to issue a complete response letter denying the supplemental new drug application (SNDA) by Teva Women’s Health, Inc,” Sebelius continued.
Jeanne Monahan, Director of Family Research Council’s Center for Human Dignity, told LifeNews after the decision: “A decision to make Plan B available for girls under the age of 17 without a prescription would not have been in the interest of young women’s health. Secretary Kathleen Sebelius was right to reject the FDA recommendation to make this potent drug available over the counter to young girls. In her own words, the research submitted to the FDA did not include data for all ages for which the drug would be used.”
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“Additionally, young people have approximately half of the sexually transmitted diseases (STDs) nationwide, according to the Center for Disease Control and Prevention (CDC). The availability of Plan B over-the-counter for all ages would have bypassed necessary routine medical care for sexually active girls. And a study released in 2010 revealed that adolescent use of Plan B was correlated with an increase in unplanned pregnancies and a high STD rate,” she said.
“There is also the issue of sexual abuse and exploitation. The average age of a girl who is sexually trafficked in the U.S. is 13 to 14. There is a real danger that Plan B could be given to young women, especially sexually abused minors, under coercion or without their consent. Interaction with medical professionals is a major screening and defense mechanism for victims of sexual abuse,” she continued. “Finally, Plan B can act in a way that can destroy life by preventing implantation. Women of all ages have the right to know how this drug may act in their bodies and on their newly developing babies.”
The morning after pill has done nothing to significantly curb the number of abortions.
Research from the pro-abortion Guttmacher Institute, a former Planned Parenthood research arm, shows “54 percent of women who have abortions had used a contraceptive method *usually condom or the pill) during the month they became pregnant.” These figures are similar to those of a report in Spain showing abortions doubling despite increased family planning promotion.
And, of the women who say they did not intend to become pregnant, the report said “most of these women have practiced contraception in the past.”
Meanwhile, a report from Planned Parenthood of Western Washington shows abortions are on the rise in Washington state even though it participated in Washington state’s Take Charge pilot program.
Take Charge is a Medicaid section 1115 Waiver program initiated in 2001 to provide free contraceptives to low-income women not already covered under Medicaid. It was originally funded for five years in 2001, then extended for three more years, and comes up for renewal in 2009. Yet the PPWW annual report indicates abortions rose 16 percent from 7,790 in 2006 to 9,059 in 2007.
The failure of birth control, the morning after pill, and contraception to lower the number of abortions is no surprise to Dr. Joseph Stanford, associate professor of family and preventive medicine at the University of Utah School of Medicine.
He says studies he and fellow researchers have done show a lower effectiveness rate than the 89 percent that Plan B maker Barr Laboratories claims.
“We did more a precise meta-analysis that shows it’s effective only 72 percent of the time, and even that number is optimistic,” he indicated.
He said studies from Europe, China and the United States show that the morning after pill does not reduce abortions.