ellaOne (ulipristal acetate) another step closer
The New York Times
June 17, 2010
By GARDINER HARRIS
Panel Recommends Approval of After-Sex Pill to Prevent Pregnancy
GAITHERSBURG, Md. — A federal advisory panel voted unanimously Thursday that federal drug regulators should approve a medicine that could help prevent pregnancy if taken as late as five days after unprotected sex.
The pill, called ella, sprang from government labs and appears to be more effective than Plan B, a morning-after pill now available over the counter to women 18 and older that gradually loses efficacy after intercourse and can be taken at latest three days after sex. ella, by contrast, works just as well on the fifth day as the first after sex.
Ella blocks the effects of progesterone, a female hormone that spurs ovulation. It is a chemical relative to RU-486, the abortion pill, and some mystery remains over exactly how it works. That mystery spurred a fierce debate outside the committee over whether it should be considered an abortion drug, a debate that prompted the posting of several uniformed police officers around the meeting room.
The F.D.A. usually follows the advice of its advisory panels but not always.
The dispute is whether the drug works by delaying ovulation (as the pill’s manufacturer claims) or by preventing a fertilized egg from implanting itself in the uterus (as anti-abortion advocates say).
Dr. Jeffrey Bray, a pharmacologist at the Food and Drug Administration, said that ella may do both. And Dr. Scott Emerson, a committee member and professor of biostatistics at the University of Washington, said any drug that can prevent pregnancy if taken five days after unprotected sex must do more than simply delay ovulation.
Animal studies showed that ella had little effect on established pregnancies, suggesting it acts differently than RU-486. Dr. David Archer, a professor of obstetrics and gynecology at Eastern Virginia Medical School who spoke on behalf of ella’s maker, said ella was not an abortion pill. “I just don’t think there is any element here that would allow me to say that this has an abortifacient activity,” Dr. Archer said.
ella is manufactured by HRA Pharma, a tiny French drug maker. If approved, the medicine would be available by prescription only. Born in the United States, ella was approved for sale in Europe last fall. During the meeting, anti-abortion and abortion rights advocates traded salvos. Wendy Wright, president of Concerned Women for America, a conservative group, called ella an unsafe abortion pill that men might slip to unsuspecting women.
“With ella, women will be enticed to buy a poorly tested abortion pill in the guise of a morning-after pill,” she said. Ms. Wright was followed to the microphone by Amy Allina, program director of the National Women’s Health Network, who said abortion questions were distractions intended to prevent “medically safe contraceptive options from becoming available.”
The committee spent the day in a cold discussion of the sobering realities that follow moments of passion, a discussion punctuated by the clacking of knitting needles from Dr. Paula Hilliard, a committee member and professor of gynecologic specialties at the Stanford University School of Medicine. It was a conversation mostly among women. Dr. Erin Gainer, HRA Pharma’s chief executive, is a young woman, and nine of the committee’s 11 members are women. Women’s health advocates say that the need for better contraceptive options is clear.
James Trussell, director of the Office of Population Research at Princeton University, who spoke on behalf of the company, said that more than one million women who do not want to get pregnant are estimated to have unprotected sex every night in the United States, and more than 25,000 become pregnant every year after being sexually assaulted. Half of all pregnancies in the United States are unintended even though contraceptives are almost universally accepted by women.
Even though ella is somewhat more effective and can be taken later than Plan B, the new drug would, if approved, probably do little to solve this epidemic of unplanned pregnancies. Plan B has been available without a prescription since 2006 for women 18 and older, but abortion and unintended-pregnancy rates have remained largely unchanged.
Women who have unprotected sex have about one chance in 20 of becoming pregnant. Those who take Plan B within three days cut that risk to about one chance in 40, and if ella is approved, that risk would be cut further to about one chance in 50. ella is less effective in obese women, studies show.
Dr. Valerie Montgomery Rice, a committee member and dean of Meharry Medical College in Nashville, pressed the company and F.D.A. to make the drug available over the counter, as is Plan B. “Why would we not move to O.T.C. status?” she asked. Dr. Gainer said the medicine was too new to consider such a step.
ella was originally developed by the National Institute of Child Health and Human Development. The institute, now named after Eunice Kennedy Shriver, is part of the National Institutes of Health. It decided in 2002 during the avowedly anti-abortion Bush administration to finance a crucial study to assess the drug’s efficacy as an emergency contraceptive.
The New York Times
June 17, 2010
By GARDINER HARRIS
Panel Recommends Approval of After-Sex Pill to Prevent Pregnancy
GAITHERSBURG, Md. — A federal advisory panel voted unanimously Thursday that federal drug regulators should approve a medicine that could help prevent pregnancy if taken as late as five days after unprotected sex.
The pill, called ella, sprang from government labs and appears to be more effective than Plan B, a morning-after pill now available over the counter to women 18 and older that gradually loses efficacy after intercourse and can be taken at latest three days after sex. ella, by contrast, works just as well on the fifth day as the first after sex.
Ella blocks the effects of progesterone, a female hormone that spurs ovulation. It is a chemical relative to RU-486, the abortion pill, and some mystery remains over exactly how it works. That mystery spurred a fierce debate outside the committee over whether it should be considered an abortion drug, a debate that prompted the posting of several uniformed police officers around the meeting room.
The F.D.A. usually follows the advice of its advisory panels but not always.
The dispute is whether the drug works by delaying ovulation (as the pill’s manufacturer claims) or by preventing a fertilized egg from implanting itself in the uterus (as anti-abortion advocates say).
Dr. Jeffrey Bray, a pharmacologist at the Food and Drug Administration, said that ella may do both. And Dr. Scott Emerson, a committee member and professor of biostatistics at the University of Washington, said any drug that can prevent pregnancy if taken five days after unprotected sex must do more than simply delay ovulation.
Animal studies showed that ella had little effect on established pregnancies, suggesting it acts differently than RU-486. Dr. David Archer, a professor of obstetrics and gynecology at Eastern Virginia Medical School who spoke on behalf of ella’s maker, said ella was not an abortion pill. “I just don’t think there is any element here that would allow me to say that this has an abortifacient activity,” Dr. Archer said.
ella is manufactured by HRA Pharma, a tiny French drug maker. If approved, the medicine would be available by prescription only. Born in the United States, ella was approved for sale in Europe last fall. During the meeting, anti-abortion and abortion rights advocates traded salvos. Wendy Wright, president of Concerned Women for America, a conservative group, called ella an unsafe abortion pill that men might slip to unsuspecting women.
“With ella, women will be enticed to buy a poorly tested abortion pill in the guise of a morning-after pill,” she said. Ms. Wright was followed to the microphone by Amy Allina, program director of the National Women’s Health Network, who said abortion questions were distractions intended to prevent “medically safe contraceptive options from becoming available.”
The committee spent the day in a cold discussion of the sobering realities that follow moments of passion, a discussion punctuated by the clacking of knitting needles from Dr. Paula Hilliard, a committee member and professor of gynecologic specialties at the Stanford University School of Medicine. It was a conversation mostly among women. Dr. Erin Gainer, HRA Pharma’s chief executive, is a young woman, and nine of the committee’s 11 members are women. Women’s health advocates say that the need for better contraceptive options is clear.
James Trussell, director of the Office of Population Research at Princeton University, who spoke on behalf of the company, said that more than one million women who do not want to get pregnant are estimated to have unprotected sex every night in the United States, and more than 25,000 become pregnant every year after being sexually assaulted. Half of all pregnancies in the United States are unintended even though contraceptives are almost universally accepted by women.
Even though ella is somewhat more effective and can be taken later than Plan B, the new drug would, if approved, probably do little to solve this epidemic of unplanned pregnancies. Plan B has been available without a prescription since 2006 for women 18 and older, but abortion and unintended-pregnancy rates have remained largely unchanged.
Women who have unprotected sex have about one chance in 20 of becoming pregnant. Those who take Plan B within three days cut that risk to about one chance in 40, and if ella is approved, that risk would be cut further to about one chance in 50. ella is less effective in obese women, studies show.
Dr. Valerie Montgomery Rice, a committee member and dean of Meharry Medical College in Nashville, pressed the company and F.D.A. to make the drug available over the counter, as is Plan B. “Why would we not move to O.T.C. status?” she asked. Dr. Gainer said the medicine was too new to consider such a step.
ella was originally developed by the National Institute of Child Health and Human Development. The institute, now named after Eunice Kennedy Shriver, is part of the National Institutes of Health. It decided in 2002 during the avowedly anti-abortion Bush administration to finance a crucial study to assess the drug’s efficacy as an emergency contraceptive.
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