The NewStandard ceased publishing on April 27, 2007.

Decision Expected Soon on ‘Morning After Pillâ€TM Availability

by Kari Lydersen

The FDA announced Friday it was not quite ready to decide on selling emergency contraception over-the-counter. Rights groups call on the agency to set aside politics to protect women’s reproductive freedom.

Jan. 25, 2005 – She might live 100 miles from the nearest town. She might not be able to take any time off from work. She might be young and afraid to let her parents or anyone else know she is sexually active. It might be Friday night and clinics are all closed for the weekend. Or she might not have health insurance or the $50 or more it would take to see a doctor without it.

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These are among the many reasons a woman could have trouble getting emergency contraception -- also known as EC, or the "morning after pill" -- since it is currently available without a doctor’s prescription in only six states.

The sooner after intercourse an emergency contraceptive is taken, the greater the efficacy in preventing conception, which is why advocates of increased access stress the importance of limiting barriers to obtaining the drug. Women should be able to obtain the drug as soon as possible, they say, without having to schedule appointments with doctors.

The US Food and Drug Administration (FDA) is expected to decide any day now whether to allow a popular contraceptive to be sold over-the-counter, enabling women to pick it up immediately after intercourse or even keep it on-hand in case of emergency.

"[The way it is now] you’re setting more and more obstacles up for young women," said Beth Pellettieri, 21, a participant in the group Advocates for Youth and their "My Voice Counts Emergency Contraceptive Campaign."

Research has shown women with access to the emergency contraception are not more likely to engage in unprotected sex or contract sexually transmitted infections.

"Having to go through making an appointment, then your doctor, whatever nurses are in the room, maybe your parents, getting transportation to the pharmacy," Pellettieri said. "One of my best friends ended up having sex on a Friday night and the condom broke so she and her boyfriend stressed out the entire weekend because the doctors were closed."

In May, the FDA angered reproductive rights advocates by denying a request by Barr Pharmaceuticals Inc. to sell its emergency contraception pill, "Plan B," over-the-counter and requesting more information from the company. Plan B is one of two emergency contraception pills approved for sale in the US with a prescription. Made with the hormone progestin*, Plan B prevents pregnancy up to 89 percent of the time if taken within 72 hours of unprotected intercourse.

In spite of recommendations to the contrary from the agency’s own advisory committee, the FDA said it was not convinced Plan B could be safely used over-the-counter by young teenagers.

But the Reproductive Health Technologies Project, a privately funded women’s advocacy organization, says Plan B could prevent up to half of the three million unintended pregnancies that happen in the country each year, as well as many of the abortions.

In December 2003, two FDA expert advisory committees voted overwhelmingly that Plan B is safe to use without a prescription. "Most committee members urged FDA and Barr not to restrict Plan B use to behind the counter where a woman must ask a pharmacist for the product, and many members said the product should not even be in the line of sight of a pharmacist to protect the privacy of the customer," says a statement from the FDA expert advisory council which voted 22-5 to allow the pill to be sold to women of all ages over-the-counter.

Critics of the FDA’s May decision accused the agency of caving in to pressure from conservatives who oppose making Plan B more readily accessible. At the time, the Washington Post reported that at least 49 Republican members of Congress, joined by conservative women’s groups, objected to selling the drug over-the-counter, citing concerns that it will lead to increased sexual promiscuity among teenagers and that the medical impact of the drug on adolescents is not well known.

Barr resubmitted a proposal asking to sell the emergency contraceptive to women over sixteen years old without a prescription, and to younger women with a doctor’s note. The upcoming decision could allow across the board sale over-the-counter, or "dual status" sale to women over sixteen without a prescription, or no change in current policy.

Advocates of increased access to emergency contraception say it is extremely easy and safe to use; it involves taking two pills twelve hours apart. They say that the "dual status" plan would mark a step in the right direction, but still not enough.

"That will still limit access for all young women, even if they are over sixteen, because they’ll have to card women or know how old they are," said Kayley Harrington, 22, also a member of Advocates for Youth and coordinator of the International Youth Leadership Council. "Someone might not have an ID, or they might not want to show it because that breaches confidentiality."

Plan B does not cause an abortion, contrary to what conservative critics say. It does not affect a woman if she is already pregnant, but if she is not, the hormones prevent an egg from being released, joining with a sperm or lodging in the uterus.

On January 7, nine women were arrested by Department of Homeland Security officers and charged with disorderly conduct after they blocked the entry to the FDA building demanding the agency allow over-the-counter sales. Bill Barker of Advocates for Youth said the online petition young members circulated gained 962 signatures in a week, and youth who visited the web site sent hundreds of emails and letters to congressional representatives and FDA officials.

"First," said Barker. "You have something that’s safe to use, and they’re just not allowing you to have it. And then there’s the age issue, where it’s like sixteen is this magical line you cross where suddenly it’s okay to get it."

A decision from the FDA was expected by the end of last week, but on Friday the agency informed Barr Pharmaceuticals of a delay in the ruling and said it was "committed to completing its review of the application in the near future."

The National Organization of Women and other groups are calling on the public to contact the FDA and voice their concerns.

"Plan B is safe, effective, easy to use and could prevent unwanted pregnancies," said NOW president Kim Gandy in a press statement. "The women who would benefit the most from the availability of emergency contraception are young women, low-income women, women without health insurance and rural, isolated women -- and any woman who is unable to reach a sympathetic physician to obtain a prescription."

Contrary to what some conservative critics say, research has also shown women with access to the pill are not more likely to engage in unprotected sex or contract sexually transmitted infections.

A study published in the Journal of the American Medical Association (JAMA) January 5 found that women who had easier access to EC were about twice as likely to use it as those who had to get a prescription, but access to the drug did not change their other behaviors.

"While use of EC was greater in the advance provision group, the ease of access did not appear to affect other sexual behaviors," reports a JAMA article on the findings. "There were no differences in rates of unprotected sex, frequency of condom use, patterns of oral contraceptive use, number of sexual partners, rates of pregnancy, or rates of [sexually transmitted infections]."

The American Academy of Pediatrics, the American Public Health Association and the American College of Obstetricians and Gynecologists are among the major US medical and health groups that support making the pill available without a prescription.

Given the political climate, Harrington said it is hard not to read political motives into the agency’s reluctance to approve the measure."There’s so much science out there that shows it’s safe and effective, the fact that it was denied the first time really makes you wonder why," she said. "There are so many other issues right now where reproductive health rights are being threatened. You can’t help but see it as another part of that."

CORRECTION: The original version of this article said that Plan B is made with progesterone, but it is in fact made of progestin.

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The NewStandard ceased publishing on April 27, 2007.

Kari Lydersen is a contributing journalist.

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