Transcript Emergency Contraception 101

Emergency
Contraception 101
September 7, 2005
Emergency Contraception:
What is It?
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Also known as Plan B or the Morning After
Pill
2 high doses of estrogen/progestin pills –
basically stronger oral contraceptives – taken
12 hours apart
EC prevents the fertilization of an egg, the
implantation of a fertilized egg, or causes the
uterus to expel an implanted egg.
Is it an Abortion?
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IT CAN BE
EC can cause abortions, even if providers
claim they do not.
Providers often define a pregnancy as
implantation, not fertilization. Under this
definition, when EC prevents a fertilized egg
from implanting, it is not technically an
abortion.
However, life begins at fertilization.
Other Considerations
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The potential health effects of long-term use
or misuse of EC
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EC is a high concentration of birth control, thus
frequent use could result in the same side-effects
experienced with birth control
Playing with hormones can be tricky ground.
History of Emergency
Contraception: Federal
Confrontations
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1997 – The Women’s Capital Corporation was formed to
market Plan B to the U.S. and Canada
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July 1999 – Plan B gained FDA approval as a
prescription drug.
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April 2003 – WCC pushed the FDA to make Plan B an
over-the-counter drug.
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December, 2003—Barr Laboratories, the manufacturer
of Plan B (EC), submitted an application to the FDA to
legalize over-the-counter sale of EC to girls and women
of all ages
History of Emergency
Contraception: Federal
Confrontations
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Feb. 2004 – Barr Pharmaceuticals, Inc. buys out Women’s Capital
Corporation to become the current developer.
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May 2004 – FDA rejects the request to make Plan B over-thecounter because not enough data supported the idea that young
women could safely use the drug without the supervision of a doctor.
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Barr Laboratories revised its request to include an age limit,
suggesting that EC be made available without a prescription to
women 16 and older. The FDA was set to rule on the measure in
January, 2005, but failed to.
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August 31, 2005—Susan Wood resigns from her position as chief of
women's health at the Food and Drug Administration.
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“The question we have
been asked to address is
whether Plan B should be
available without a
prescription on a pharmacy
shelf, similar to the way
other over-the-counter
medicines like some cough
syrups and allergy pills are
sold, for women age 16 and
older, and remain
prescription-only for those
under the age of 16.” FDA
Commissioner Lester M.
Crawford, August 26, 2005
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“This was a personal decision for me and it was
about what I could do inside the agency and the fact
that I couldn't stand quietly as head of women's
health while this decision, which is contrary to
women's health, was made.” Susan Wood
Statewide Controversy
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August 4, 2005—Governor George Pataki of New
York vetoed a bill that would provide over-thecounter EC, on grounds that it did not do enough to
protect minors. The bill provided no limit on the
number of pills that could be dispensed at one time.
July, 2005—Governor Mitt Romney of
Massachusetts vetoed similar legislation.
Colorado Governor Bill Owen vetoed a bill that
would have required information about emergency
contraception to be present in all health care
facilities. He reasoned that religious hospitals and
care providers who are morally opposed to EC
should not be forced to provide such information.
Legal Status of EC
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Plan B and Preven, 2 similar drugs, are
available by prescription only
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FDA’s evaluation center has said that Plan B is
safe to sell over the counter to women over 17,
but the FDA has not yet approved this measure.
They are opening the decision up to the public so
that all interested parties can weigh in on the
decision.
Emergency Contraception:
What it is Not
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EC is NOT RU-486, or the Abortion Pill
RU-486 is taken 5-7 weeks into pregnancy
3 clinician visits are required: Day 1, Day 3,
and Day 14 for check-up
RU-486 alters the placenta so that the fetus
starves to death. A chemical called
Prostaglandins then induces contractions that
expel the fetus.
History of RU-486
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1981 – Developed in France by Roussel-Uclaf, a French branch
of the German company, Hoechst AG, formerly known as IG
Farben.
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Sept. 1988 – Approved for distribution and use in France.
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Oct. 1988 – Roussel-Uclaf stopped distribution because of prolife protesters in the U.S., France, and West Germany.
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(a few days later) Oct. 1988 – The French Health Minister
ordered RU-486 back on the market calling it “the moral property
of women.”
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1991 – Approved for distribution in Great Britain.
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1992 – Approved for distribution in Sweden.
US History with RU-486
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The Bush (Sr.) administration placed RU-486 on an FDA list of items
banned for importation to the U.S.
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The Clinton administration requested that the FDA reexamine the ban.
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May 1994 – Roussel-Uclaf gave the Population Council, a research
institution, the rights to test the drug in the U.S. Since no U.S. company
wanted to be connected to RU-486, the Population Council had to use a
Chinese manufacturer. To market the drug in the U.S., the Population
Council created a new company, called Danco.
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Sept. 2000 – RU-486 gains FDA approval. Doctors may prescribe the
drug if:
1. Doctors can tell how far along the pregnancy is.
2. The doctor must be near a hospital.
3. The doctor must be able to perform a surgical
abortion if the pill doesn’t work.
Legal Status of RU-486
(Mifeprex)
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It is legal, but definitely prescription only
FDA issued a public health advisory on July
22, 2005 stating that 4 known deaths have
occurred from use of the drug
Advisory also outlined the only approved
regimen for taking the drug
EC On-Campus: The Student
Health Center
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Examination including:
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Medical history form
Informed consent form
Pregnancy test if more
than 28 days since last
period
Possibly a pelvic exam
Check for vital signs
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Prescriptions
Recommend a follow
up gynecological exam
EC On-Campus: VOX’s EC Van
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National campaign to make EC more accessible
Consultations/prescriptions ($27) from a registered nurse on
board
“All you need is an ID, check or cash, and the EC will be sent
to you within 5 business days”
“The van” stops by once a semester—be ready!
Bibliography
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“Plan B Emergency Contraception: Still Waiting for the FDA”
by Aaron Coles
http://www.plannedparenthood.org/pp2/portal/files/portal/webzine/eyeonextremism/eoe-050503ec-otc.xml
“Dismay over delay spurred FDA officer”
by Alison Neumer Lara http://www.chicagotribune.com/features/printedition/chi0509070010sep07,1,1821274.story?ctrack=1&cset=true
"The Best Kept (ugly little) Secret in America“
by David C. Reardon, Ph.D. http://www.afterabortion.org/PAR/V6/n4/birthcontrol.htm
“Presidential Hopefuls Veto Emergency Contraception Despite FDA Support”
http://www.democracynow.org/article.pl?sid=05/08/04/1357251
“Pataki vetoes morning-after pill legislation” http://www.msnbc.msn.com/id/8831350/
“Time for Plan B”
by Grace Hood http://www.boulderweekly.com/newsspin.html
Baptists for Life: http://www.bfl.org
Life Dynamics.com: http://www.lifedynamics.com
Planned Parenthood of Amarillo and the Texas Panhandle: www.ppatp.org
Student Health Center: http://www.wm.edu/health/emergency_contraception.php
FDA: http://www.fda.gov, http://www.fda.gov/bbs/topics/news/2005/NEW01223.html,
http://www.fda.gov/cder/drug/infopage/mifepristone/,
http://www.fda.gov/fdac/features/1997/babytabl.html
http://www.freepregnancyhelp.com/ecp.html
Clemson University: http://www.clemson.edu/research/orcSite/orcIRB_DefsP.htm
NARAL:
http://www.naral.org/yourstate/whodecides/states/virginia/didyouknow.cfm?RenderForPrint=1
VOX: http://www.wm.edu/so/vfpp
Cavalier Daily: http://www.cavalierdaily.com/CVArticle.asp?ID=19828&pid=1153