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Entries in Plan B (9)

Wednesday
May012013

FDA Approves Over-the-Counter Plan B for Woman 15 and Older

Scott Olson/Getty Images(WASHINGTON) -- The Food and Drug Administration has approved Plan B One-Step, a brand of emergency contraceptive, to be available for women 15 and older without a prescription.

This comes almost a month after a federal judge ordered the FDA to make Plan B available to everyone over-the-counter, which will go into effect on May 5, unless the FDA appeals the ruling.

"The Department of Justice is considering next steps in the litigation," the FDA said in a statement. "In the meantime, the FDA took independent action to approve the pending application on Plan B One-Step for use without a prescription by women 15 years of age or older."

Judge Edward Korman ordered emergency contraceptive to be made available over the counter on April 5, citing "bad faith" that resulted in restricted access to the drug in the past. Prior to that, it was available to everyone 17 and older without a prescription.

When Korman, who presides over the District Court of Eastern New York, wrote his ruling, Teva Pharmaceutical Industries, which makes Plan B One-Step, had an application pending with the FDA to get the prescription-free age lowered from 17 to 15, according to the FDA statement.

"While there are still practical questions to resolve, this is an important step forward to expand access to emergency contraception and for preventing unintended pregnancy," said President of Planned Parenthood Federation of America's President Cecile Richards.

The morning-after pill is intended to be used when other contraception fails, such as when a condom breaks. Containing the synthetic hormone levonorgestrel, the pill works by preventing a fertilized egg from attaching itself to the uterine wall. But it must be taken within 72 hours of unprotected sex. It cannot terminate an existing pregnancy.

Although Wednesday's FDA approval means women seeking Plan B will need to have identification to prove they are of age to purchase it, the drug will no longer be available only when the pharmacy is open, according to an FDA statement. Instead, it will be available in the family planning and female health aisles.

In December 2011, Health and Human Services Secretary Kathleen Sebelius sparked controversy when she overruled the FDA after it recommended that emergency contraception be sold over the counter. The FDA spent 10 months reviewing scientific data before making its decision, but Sebelius said there wasn't enough data to declare the product safe.

"Indeed, it is hardly clear that the secretary had the power to issue the order, and if she did have that authority, her decision was arbitrary, capricious and unreasonable," Korman wrote in his ruling.

Although the FDA has not yet made an announcement regarding Korman's order, some women's health organizations are concerned.

"The FDA is under a federal court order that makes it crystal clear that emergency contraception must be made available over the counter, without restriction to women of all ages by next Monday," Nancy Northup, president and CEO of the Center for Reproductive Rights, said in a press release.

She said requiring proof of age is a "significant barrier that all too many women of all ages will still find" even with the prescription-free age lowered to 15.

"These are daunting and sometimes insurmountable hoops women are forced to jump through in time-sensitive circumstances," she said. "And we will continue our battle in court to remove these arbitrary restrictions on emergency contraception for all women."

Copyright 2013 ABC News Radio

Monday
Nov262012

Doctors to Advise Teens on Emergency Contraception

Joe Raedle/Getty Images(NEW YORK) – Does your teen know about Plan B? If not, he or she may soon get acquainted with it. All pediatricians are now encouraged to advise adolescents about the use of emergency contraception, according to Monday’s policy statement released online by the American Academy of Pediatrics.

The statement says that pediatricians should inform teenaged patients about the use, availability, and effects of all forms of emergency contraception as a day-to-day practice. In addition, both male and female patients should be encouraged to get tested or treated for sexually transmitted diseases, and talk about regular contraception methods as a follow up to the use of emergency contraception.

Co-author and Professor of Adolescent Medicine at Seattle Children’s Hospital Cora Breuner highlights the fact that these are not the same as abortion drugs or methods.

“These are progestin only medications that prevent fertilization. They do not prevent implantation, so these are not considered abortive drugs,” she says.

Breuner also states that the primary focus of the statement is to prevent unwanted teen pregnancies.  The United States continues to have a higher teen birth rate compared to developed countries. Breuner and her colleagues discovered that teenagers have been found to use emergency contraception more often if they are notified about it in advance.

“I think this will provide an impetus to have a conversation with your practitioner as a parent or a patient about what you plan to do about your own family planning and reproductive health before there has to be a discussion about "I had unprotected sex" or "I had non-consensual sex,” she says.

Copyright 2012 ABC News Radio

Wednesday
May092012

IUDs Work Best for Emergency Contraceptive, Study Finds

Spike Mafford/Photodisc/Thinkstock(PRINCETON, N.J.) -- Intrauterine devices, or IUDs, have been shown to be the best and most reliable emergency contraceptive for women, according to a new study published in the journal Human Reproduction.

An IUD is a T-shaped plastic or copper device that is placed in a woman's uterus to prevent pregnancy.  They can be left in the womb between five and 10 years, depending on the brand, but they can also be used as a means of emergency contraceptive.  They should be inserted within five days of unprotected sex to properly protect, experts said.

The research showed that IUDs had a failure rate of less than one per 1,000, which was more effective than the morning-after pill, which had a failure rate of 1 to 2 percent.  The morning-after pill, or Plan B One-Step, is a pill that should be taken within 72 hours of unprotected sex to avoid pregnancy.

"Emergency insertion of a copper IUD is extremely effective," said James Trussell, professor of public and international affairs at Princeton University and lead author of the study.  "We would hope [the findings] would encourage clinicians to talk with women about emergency insertion of a copper IUD during regular visits for later use, should the need arise."

The study analyzed data from 42 studies conducted in six different countries (China, Egypt, Italy, The Netherlands, U.S.A. and the U.K.) between 1979 and 2011.  They found that women became pregnant at a rate of 0.09 percent if they used an IUD, as opposed to the 1 to 2 percent pregnancy rate on the morning-after pill.

The research also found that using an IUD for emergency contraception worked just as effectively in women with higher body mass index, while the morning-after pill became less effective at preventing pregnancy in women with higher BMI.

"IUDs are certainly a highly effective form of emergency contraception," said Dr. Ranit Mishori, an assistant professor in the department of family medicine at Georgetown University.  "The study appears to confirm it, [but] I think not many women are aware that it is an effective option."

While the device is indeed better at preventing pregnancy, experts say that it is not necessarily the best option for everyone.

"Here are the problems: the IUD has to be inserted and most of the time, ordered," said Dr. Jacques Moritz, director of gynecology at St. Luke's-Roosevelt Hospital in New York.  "They are way overpriced in this country.  You can't just walk in my office and get an $800 IUD.  We have to get it authorized and ordered."

On the other hand, any woman over the age of 17 can buy Plan B One-Step at a pharmacy without a prescription.  Females under the age of 17 must have a prescription to obtain the product.

Copyright 2012 ABC News Radio

Wednesday
Jan252012

Poor Teens Lack Access to Emergency Contraception: Study

Joe Raedle/Getty Images(BOSTON) -- Low-income communities have the highest teen pregnancy rates in the U.S., yet emergency contraception may be hardest for girls in those areas to get their hands on, according to a new study.

While pharmacies in underserved communities are just as likely to stock the morning-after pill as pharmacies in more affluent ones, researchers from Boston Medical Center found that pharmacists in poorer areas were more often misinformed about the law and mistakenly were denying 17-year-old girls access to Plan B.

Plan B, or levonorgestrel, prevents a fertilized egg from attaching to the wall of the uterus, if taken within 72 hours of unprotected sex.  The drug is sometimes confused with the so-called abortion pill, RU-486, but unlike RU-486, Plan B cannot be used to terminate a pregnancy.

In 2006, Plan B became available for purchase by adults in the U.S. without a prescription. Three years later, in 2009, the FDA lowered the age at which Plan B could be dispensed without a prescription to allow 17 year olds access to the drug without a prescription.

According to the study, pharmacists and pharmacy staff may not be adequately apprised of the change in the law.

"We were very surprised by the results" of the study, said Dr. Tracey Wilkinson, its senior author and a pediatrician at Boston Medical Center. "There is a lot of misinformation about emergency contraception."

Wilkinson also suggested that the box labels on the contraception -- as well as the advertising -- may not be clear, and may be contributing to the problem.

In the study, published in the Journal of the American Medical Association, graduate assistants posed as 17-year-old adolescents and called more than 900 pharmacies in diverse neighborhoods throughout the U.S. to see whether pharmacists would dispense the morning-after pill to the "teen" customers.

Eighty percent of pharmacies said they had Plan B in stock, and the availability of the pill was consistent across the diverse communities, researchers said.  But 19 percent of all the pharmacists told the "teenagers" that they could not obtain the pill under any circumstance, and they said the misinformation occurred more often -- 23.7 percent versus 14.6 percent -- in low-income neighborhoods.

While this study focused on pharmacies, Wilkinson said there is a lot of confusion about Plan B within the medical community at large, not just the pharmacies. Given the controversy surrounding the drug, and the changes in the rules and guidelines surrounding access, it's, "not really surprising that it permeates everywhere,'' she said.

Whatever the reason for the misinformation, whether it's a problem with staff education in the pharmacies, high turnover, the relative rarity of teens asking for the drug, she said, "at the end of the day, it puts adolescents in poor neighborhoods at a disadvantage," she said.

Copyright 2012 ABC News Radio

Thursday
Dec082011

Obama Defends Plan B Decision, Says He Was Not Involved

Joe Raedle/Getty Images(WASHINGTON) -- President Obama said Thursday that he did not intervene in the decision by his Secretary of Health and Human Services Kathleen Sebelius to block the Plan B morning-after pill from being sold over the counter to young teens, and offered his support for the decision, “as the father of two daughters.”

“I did not get involved in the process,” the president told reporters at the White House. “This was a decision that was made by Kathleen Sebelius, the Secretary of HHS.”

Sebelius stepped in Wednesday to prevent the Food and Drug Administration from approving a request from the manufacturer to remove the requirement that girls under the age of 17 need a prescription for the drug.

On Thursday, Obama offered his support for Sebelius’ decision. “I think it is important for us to make sure that, you know, we apply some common sense to various rules when it comes to over-the-counter medicine,” he said. “When it comes to 12-year-olds or 13-year-olds, the question is, 'Can we have confidence that they would potentially use Plan B properly?'"

The president said that Sebelius made the decision because she was not confident that 10 or 11-year-olds should be able to buy the drug, “alongside bubblegum or batteries,” especially when the drug could have adverse effects if used improperly.

“I think most parents would probably feel the same way,” Obama said.

Copyright 2011 ABC News Radio

Wednesday
Dec072011

Plan B: 'Morning After Pill' Blocked from Hitting Drug Store Shelves

Joe Raedle/Getty Images(WASHINGTON) -- U.S. Department of Health and Human Services Secretary Kathleen Sebelius has blocked the Plan B "morning after" birth control pill from hitting drug store shelves, countering recommendations from the U.S. Food and Drug Administration.

"Today's action reflects my conclusion that the data provided as part of the actual use study and the label comprehension study are not sufficient to support making Plan B One-Step available to all girls 16 and younger, without talking to a health care professional," Sebelius wrote in a statement.

FDA Commission Dr. Margaret Hamburg said in a statement that she believes there is adequate and well-supported data that shows Plan B One-Step is safe and effective for nonprescription use for all females of childbearing years -- an opinion vetoed by Sebelius.

"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 wrote.

The move would have landed the emergency contraceptive on drugstore shelves alongside condoms, spermicides and contraceptive sponges. Instead, women 17 and older can continue to buy the high-dose hormone pill over the counter, but girls younger than 17 still need a prescription.

Teva Pharmaceutical Industries Ltd., the maker of Plan B One-Step, requested the switch in February.

Plan B, or levonorgestrel, is a progestin-only emergency contraceptive that can prevent a fertilized egg from attaching to the wall of the uterus if taken within 72 hours of unprotected sex. The drug is not effective if the woman is already pregnant, and it reportedly does not pose harm to a fetus.

In 2008 the FDA ruled that women 18 and older could buy Plan B over the counter. A year later, the agency expanded the regulation to include those 17 and older.

Copyright 2011 ABC News Radio

Wednesday
Dec072011

FDA to Decide Whether to Lift Age Limit on 'Morning After Pill'

Joe Raedle/Getty ImagesUPDATE: U.S. Department of Health and Human Services Secretary Kathleen Sebelius has blocked the Plan B morning-after birth control pill from hitting drug store shelves, countering recommendations from the U.S. Food and Drug Administration.

(WASHINGTON) -- The Food and Drug Administration is set to weigh in on Wednesday whether the age limit on who can purchase an emergency contraceptive pill should be scrapped, making the drug available to everyone over the counter.

Plan B, also known as the "morning after pill," is currently available at the pharmacy counter without a prescription to women 17 and older.  Those who are younger can still get the pill, but they need to have it prescribed to them by their doctors.

Teva Pharmaceutical Industries Ltd., the makers of Plan B, issued the request in February to place its drug on store shelves.

"Label comprehension and safety data show that all women are able to safely and effectively take this product," Denise Bradley, senior director of corporate communications at Teva Pharmaceuticals, told ABC News at the time. "It is not typical for any women's health product to have age restrictions."

Plan B, or levonorgestrel, is a progestin-only emergency contraceptive that can prevent a fertilized egg from attaching to the wall of the uterus if taken within 72 hours of unprotected sex. The drug is not effective if the woman is already pregnant, and it reportedly does not pose harm to a fetus.

Copyright 2011 ABC News Radio

Tuesday
Jul192011

Health Law Could Require Coverage of ‘Full Range’ of Birth Control

Stockbyte/Thinkstock(WASHINGTON) -- A report released Tuesday and requested by the government recommends that the “full range” of birth control methods, including the “morning after pill” known as Plan B as well as oral contraceptives, should be offered to “all women with reproductive capacity” at no cost under the Affordable Care Act.

The Department of Health and Human Services requested the study to determine which preventative services are vital to women’s health and well-being and should be added to the co-pay free list.

HHS Secretary Kathleen Sebelius will make a decision by Aug. 1 on whether or not to include the recommendations.  They would go into effect one year after Sebelius makes her decision.

“This report is historic,” Sebelius said in a statement Tuesday. “Before today, guidelines regarding women’s health and preventive care did not exist.”

Planned Parenthood lauded the report in a statement.

“Millions of women, especially young women, struggle every day to afford prescription birth control,” said Cecile Richards, president of Planned Parenthood Federation of America.  “Today’s recommendation brings us a step closer to ensuring that all newly insured women under the health care reform law will have access to prescription birth control without out-of-pocket expenses.  This would be a tremendous stride forward for women’s health in this country.”

But social conservative groups said it would lead to government-sponsored abortion.

The Family Research Council, a Christian advocacy group, said including Plan B in the Affordable Care Act’s insurance coverage “essentially would mandate coverage for abortion.”

The Guttmacher Institute, a research group that advocates for abortion rights,  estimated that unintended pregnancies cost taxpayers about $11 billion per year because two-thirds of them are funded by public insurance such as Medicaid.

Other services recommended by the committee include STD and HIV counseling, gestational diabetes screening for pregnant women, counseling and equipment to promote breast feeding, screening and counseling to help prevent domestic violence, yearly preventative care visits, and human papillomavirus testing for women older than 30 to help prevent cervical cancer.

The study particularly focused on women because reproductive and gender-specific conditions lead to women using more preventative care than men on average. Therefore, women face higher out-of-pocket costs, the report noted.

Copyright 2011 ABC News Radio

Monday
Feb282011

Drug Maker Wants to Lift Age Restrictions on Morning After Pill

Photo Courtesy - Joe Raedle/Getty Images(WASHINGTON) -- Teva Pharmaceutical Industries Ltd., the maker of Plan B One-Step, has requested that the U.S. Food and Drug Administration switch this "morning after" pill to full nonprescription status for women of all ages.

Currently, women 17 and older can buy the high-dose birth control pill over-the-counter, without a prescription.  Those younger than 17 need a prescription to obtain the high-dose hormone pill.

"Our 2003 Plan B application and our current application for Plan B One-Step is seeking over-the-counter status for the product based on data that demonstrate the product meets the scientific criteria that the FDA has established for over the counter products," said Denise Bradley, senior director of corporate communications at Teva Pharmaceuticals.  "Label comprehension and safety data show that all women are able to safely and effectively take this product.  It is not typical for any women's health product to have age restrictions."

Plan B, or levonorgestrel, is a progestin-only emergency contraceptive that can prevent a fertilized egg from attaching to the wall of uterus if taken within 72 hours of unprotected sex.  The drug is not effective if the woman is already pregnant, and it does not pose harm to a fetus.

According to Jeff Ventura, a spokesman for the FDA, a prescription drug may be eligible for over-the-counter status if it is determined that dispensing the drug by prescription is not necessary for the protection of the public health, and the drug is safe and effective for use in self-medication as directed in proposed labeling.

"The application will go through the normal FDA review process," said Ventura in a statement.  "It will be evaluated against the same scientific and regulatory criteria as all other over-the-counter switch applications."

Copyright 2011 ABC News Radio







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