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FDA Debating Morning-After Pill Status
Aired December 16, 2003 - 14:26 ET
THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
KYRA PHILLIPS, CNN ANCHOR: Now to Washington, where a new day may be dawning for the morning-after pill. The FDA is strongly considering allowing Plan B and other emergency contraception to be sold without a prescription. Gynecologists are urging the pills be as readily available as possible. But critics say medical advice is, well, critical.
CNN medical correspondent Holly Firfer now joining me with the details -- Holly.
HOLLY FIRFER, CNN MEDICAL CORRESPONDENT: Well, Kyra, an FDA board is listening to both sides of the debate over emergency contraception today. The issue is over how the drug is sold. Right now Plan B is available with the doctor's prescription in five states. But many in the medical community say people don't always need it Monday through Friday, 9:00 to 5:00, your doctor's hours, so they want to make it available at any time over the counter.
First, let's talk about what Plan B is. It's essentially two high-dose birth control pills that disrupt a woman's normal menstrual cycle. Taken within 72 hours after unprotected sex, it can affect the transport of sperm or eggs preventing fertilization. It can block the surge of hormones that cause fertilization and thicken the mucous in the uterus and changing the lining making it impossible for an egg to implant.
But it cannot prevent a pregnancy that has already happened. Once that fertilized egg is implanted in the uterine wall, Plan B is ineffective.
Today's debate is focusing on whether anyone should be able to get this at their local drugstore. This morning the company presented its reasons why they feel it should be available over the counter.
(BEGIN VIDEO CLIP)
CAROLE BEN-MAIMON, WOMEN'S CAPITAL CORP.: Over three million unintended pregnancies occur each year. With typical use, women using condoms, 15 percent of them will become pregnant each year. And 8 percent of women using oral contraceptives will become pregnant. There are approximately 800,000 unintended pregnancy in teenagers.
(END VIDEO CLIP)
FIRFER: In the public comment period, one group opposed the idea. (END VIDEO CLIP)
UNIDENTIFIED FEMALE: We're very disturbed by Plan B's promoters' emphasis on access but not on women's safety. There have been no studies done on the long-term effects of women after taking Plan B. There have been no studies on the effects of multiple use.
(END VIDEO CLIP)
FIRFER: Now, a study on Plan B show because the pill contains only progestin there is no risk of blood clots. There are no other major complications, but there are some side effects you should know about.
Those include nausea, abdominal pain, fatigue, headache and menstrual changes. And there are some women who should not use emergency contraception. Those women include pregnant women, women with undiagnosed vaginal bleeding or women with an allergy to the product.
And, Kyra, today the FDA advisory board will talk among themselves, make a decision to recommend whether or not to put this drug over the counter. Then the FDA will take that into advisement and make a decision sometimes in the near future.
PHILLIPS: What's the difference between this and RU-46?
FIRFER: Good question. They're completely different. RU-486 is to be used when a woman is already pregnant. When a fertilized egg embeds in the uterine lining, it's meant to terminate that pregnancy. This is to prevent the pregnancy from happening in the first place.
PHILLIPS: Holly Firfer, thank you.
TO ORDER A VIDEO OF THIS TRANSCRIPT, PLEASE CALL 800-CNN-NEWS OR USE OUR SECURE ONLINE ORDER FORM LOCATED AT www.fdch.com
Aired December 16, 2003 - 14:26 ET
THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
KYRA PHILLIPS, CNN ANCHOR: Now to Washington, where a new day may be dawning for the morning-after pill. The FDA is strongly considering allowing Plan B and other emergency contraception to be sold without a prescription. Gynecologists are urging the pills be as readily available as possible. But critics say medical advice is, well, critical.
CNN medical correspondent Holly Firfer now joining me with the details -- Holly.
HOLLY FIRFER, CNN MEDICAL CORRESPONDENT: Well, Kyra, an FDA board is listening to both sides of the debate over emergency contraception today. The issue is over how the drug is sold. Right now Plan B is available with the doctor's prescription in five states. But many in the medical community say people don't always need it Monday through Friday, 9:00 to 5:00, your doctor's hours, so they want to make it available at any time over the counter.
First, let's talk about what Plan B is. It's essentially two high-dose birth control pills that disrupt a woman's normal menstrual cycle. Taken within 72 hours after unprotected sex, it can affect the transport of sperm or eggs preventing fertilization. It can block the surge of hormones that cause fertilization and thicken the mucous in the uterus and changing the lining making it impossible for an egg to implant.
But it cannot prevent a pregnancy that has already happened. Once that fertilized egg is implanted in the uterine wall, Plan B is ineffective.
Today's debate is focusing on whether anyone should be able to get this at their local drugstore. This morning the company presented its reasons why they feel it should be available over the counter.
(BEGIN VIDEO CLIP)
CAROLE BEN-MAIMON, WOMEN'S CAPITAL CORP.: Over three million unintended pregnancies occur each year. With typical use, women using condoms, 15 percent of them will become pregnant each year. And 8 percent of women using oral contraceptives will become pregnant. There are approximately 800,000 unintended pregnancy in teenagers.
(END VIDEO CLIP)
FIRFER: In the public comment period, one group opposed the idea. (END VIDEO CLIP)
UNIDENTIFIED FEMALE: We're very disturbed by Plan B's promoters' emphasis on access but not on women's safety. There have been no studies done on the long-term effects of women after taking Plan B. There have been no studies on the effects of multiple use.
(END VIDEO CLIP)
FIRFER: Now, a study on Plan B show because the pill contains only progestin there is no risk of blood clots. There are no other major complications, but there are some side effects you should know about.
Those include nausea, abdominal pain, fatigue, headache and menstrual changes. And there are some women who should not use emergency contraception. Those women include pregnant women, women with undiagnosed vaginal bleeding or women with an allergy to the product.
And, Kyra, today the FDA advisory board will talk among themselves, make a decision to recommend whether or not to put this drug over the counter. Then the FDA will take that into advisement and make a decision sometimes in the near future.
PHILLIPS: What's the difference between this and RU-46?
FIRFER: Good question. They're completely different. RU-486 is to be used when a woman is already pregnant. When a fertilized egg embeds in the uterine lining, it's meant to terminate that pregnancy. This is to prevent the pregnancy from happening in the first place.
PHILLIPS: Holly Firfer, thank you.
TO ORDER A VIDEO OF THIS TRANSCRIPT, PLEASE CALL 800-CNN-NEWS OR USE OUR SECURE ONLINE ORDER FORM LOCATED AT www.fdch.com
