FDA: Morning-after pill to move over-the-counter


The government is moving the morning-after pill over the counter but only those 15 and older can buy it — an attempt to find middle ground just days before a court-imposed deadline to lift all age restrictions on the emergency contraceptive.

Today, Plan B One-Step is sold behind pharmacy counters, and buyers must prove they’re 17 or older to buy it without a prescription. Tuesday’s decision by the Food and Drug Administration lowers the age limit and will allow the pill to sit on drugstore shelves next to spermicides or other women’s health products and condoms — but anyone who wants to buy it must prove their age at the cash register.

Some contraceptive advocates called the move promising.

“This decision is a step in the right direction for increased access to a product that is a safe and effective method of preventing unintended pregnancies,” said Sen. Patty Murray, D-Wash. “It’s also a decision that moves us closer to these critical availability decisions being based on science, not politics.”

But earlier this month, U.S. District Judge Edward Korman of New York blasted the Obama administration for imposing the age-17 limit, saying it had let election-year politics trump science and was making it hard for women of any age to obtain the emergency contraception in time. He ordered an end to the age restrictions by Monday.

The women’s group that sued over the age limits said Tuesday’s action is not enough, and it will continue the court fight.

Lowering the age limit “may reduce delays for some young women but it does nothing to address the significant barriers that far too many women of all ages will still find if they arrive at the drugstore without identification,” said Nancy Northup, president of the Center for Reproductive Rights.

The FDA said the Plan B One-Step will be packaged with a product code that prompts the cashier to verify a customer’s age. Anyone who can’t provide such proof as a driver’s license, birth certificate or passport wouldn’t be allowed to complete the purchase.

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

Half the nation’s pregnancies every year are unintended, and doctors’ groups say more access to morning-after pills could cut those numbers. The pills contain higher doses of regular contraceptives, and if taken within 72 hours of unprotected sex, can cut the chances of pregnancy by up to 89 percent.

The FDA had been poised to lift all age limits and let Plan B sell over-the-counter in late 2011, when Health and Human Services Secretary Kathleen Sebelius, in an unprecedented move, overruled her own scientists. Sebelius said some girls as young as 11 are physically capable of bearing children, but shouldn’t be able to buy the pregnancy-preventing pill on their own.

President Barack Obama supported Sebelius’ move and a spokesman said earlier this month that the president’s position hadn’t changed.

The FDA said Tuesday’s decision was independent of the court case. Instead, after the Obama administration’s 2011 action, Plan B maker Teva Women’s Health had filed a new application with the age-15 compromise.


The Family Research Council opposes making Plan B available OTC for the following reasons related to women’s health and matters of law:

Birth control pills, which are essentially a lower dose regimen of Plan B, require a prescription. They are not available OTC. They require an appointment with a licensed clinician to determine contraindications, obtain a prescription, and provide for medical oversight throughout the usage period. The OTC status would increase access to Plan B to larger populations of women, including women who have not been screened for contraindications.

Lack of scientific studies examining risks. There is a clear lack of scientific studies on the long-term-effects of Plan B with respect to high dosage and repeated use in both women and adolescents. While the patient package directions on Plan B state it is not to be used more than twice a month, the directions and promotions of Plan B state it is also to be used in emergencies. These emergencies include unprotected sex and the failure of other birth control devices–factors that may arise more than twice a month.

STD rates have skyrocketed in countries where Plan B has been deregulated. Since becoming available in the United Kingdom in 2001, Plan B usage among teenage girls has more than doubled. STDs with sharp increases include chlamydia and gonorrhea, with the highest increases in 16 to 19 year olds. Because STD’s such as chlamydia can cause infertility in women, the impact that increased access to and usage of Plan B has on STD rates could have a direct causal relationship to increased future infertility rates of U.S. women.

Contrary to predictions, abortions have not decreased with Plan B deregulation. In Scotland, where Plan B has been available for over 15 years, abortion rates showed an increase between 1990 and 1999. In Glasgow, where Plan B prescriptions increased 300 percent from 1992 to 1999, abortions did not decrease. In the United Kingdom, where deregulation to “pharmacy” status took place in 2001, abortions have not decreased. Planned Parenthood clinics in the United States have experienced a simultaneous sharp increase in Plan B prescriptions and abortions performed in centers they operate.

Masking of sexual abuse. The potential for Plan B to be given to women, especially sexually abused women and minors, without their consent or knowledge is a clear and present danger. Interaction with medical professionals is a major detection and prevention mechanism for victims of sexual abuse. The elimination of routine examination of sexually active girls and women could cover up both sexual abuse and exploitation.

Link of Plan B to ectopic pregnancy. Statements from the World Health Organization and leading medical officials taken together provide a warning that increased risk of ectopic pregnancy exists with Plan B usage.6 Additionally, common physical side-effects a woman experiences following Plan B usage often mimic ectopic pregnancy symptoms, including cramping and severe pain. Consequently, there is valid concern for Plan B usage to actually mask ectopic pregnancy, an acute, life-threatening condition.




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