Plan B Available for New York Women of All Ages

Do you think that New York should follow the example set by California, Alaska, Vermont, Massachusetts, and Hawaii (five states with Republican governors)-- and the example set by New Hampshire, Washington, New Mexico, and Maine-- that women of any age should be able to buy Plan B "morning-after" medications without a doctor's prescription?

There are "more than 800,000 teen pregnancies a year in the U.S.", according to an Associated Press report August 25th (see below)-- extrapolating that means over 20,000 annually here in New York alone.

"In 2000, the availability of emergency contraception prevented more than 100,000 pregnancies, about half of which would have ended in abortion, according to Guttmacher Institute estimates; there are roughly 3.1 million unplanned pregnancies in the United States each year," according to the same article.
["Access to Plan B May Have Limited Effect" by Andrew Bridges (AP 8/25/06): wtop.com/?nid=106&sid=586862]

Sign on to this petition if you agree that New York should do the same thing as those nine states listed above and allow women of all ages to get Plan B without a doctor's prescription, as the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists have recommended (see below).

Joel Tyner
County Legislator
Clinton/Rhinebeck
324 Browns Pond Road
Staatsburg, NY 12580
[email protected]
[see pro-choice petition @ JoelTyner.org]

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Statement of The American College of Obstetricians and Gynecologists
On the FDA's Approval of OTC Status for Plan B [8/24/06]
http://www.acog.org/from_home/publications/press_releases/nr08-24-06.cfm

[The American College of Obstetricians and Gynecologists is the
national medical organization representing over 51,000 members who
provide health care for women.]

Washington, DC -- In light of the US Food and Drug Administration's (FDA) decision to approve over-the-counter (OTC) status for Plan B emergency contraception (EC) for women age 18 and older, The American College of Obstetricians and Gynecologists (ACOG) today emphasized the need for unimpeded access to EC for all women of reproductive age. Timely access to emergency contraception is pivotal in reducing the number of unintended pregnancies and abortions in the US.

By restricting its OTC availability to women age 18 and older, the FDA has missed an unparalleled opportunity to prevent teenage pregnancies. Each year there are more than 800,000 teen pregnancies in the US, with many ending in abortion. Pregnancy itself is not without risk, especially for a young woman. There is no scientific or medical reason to impose an age restriction and to withhold EC from this population. EC is safe for over-the-counter use by women of all ages.

A common goal is for every pregnancy to be planned for the optimal health of the woman and her baby. However, contraceptive failures occur, accidents happen, and teenage women in particular may not always have control over their own sexuality. Pregnancy should not be viewed punitively, as a "price" that they have to pay. Emergency contraception offers a safe and effective alternative that should be readily available.

Moreover, women need to know about EC and how they can get it. ACOG will continue efforts to promote its Ask me. program aimed at informing women of all ages about emergency contraception and increasing awareness of EC so that it's no longer the best-kept secret in medicine. ACOG reaffirms its priority of preventing unintended pregnancy and reducing the number of abortions in this
country.

While the FDA's approval of EC over the counter for women age 18 and older may be perceived as a substantial victory for women across the country, that is not necessarily the case. Access problems will still exist in states where regulations do not permit pharmacies to dispense EC directly to women without a prescription and where individual pharmacists refuse to fill prescriptions. ACOG commends the handful of states who have put women first by allowing them access to EC without a prescription (AK, CA, HI, ME, MA, NH, NM, VT, and WA) and encourages other states to take up similar bills when legislatures reconvene.

Emergency contraception, also called the morning-after pill, is a higher dosage of the same hormones found in ordinary birth control pills. It is highly effective in reducing a woman's chance of pregnancy after a contraceptive failure or unprotected sex. This can include rape. If taken within 72 hours of unprotected sex, EC prevents up to 89\% of pregnancies; it is most effective if taken within 24 hours.

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"Plan B Decision by FDA a Victory for Common Sense" [Guttmacher Institute]
http://www.guttmacher.org/media/index.html#news1

On August 24, after almost three years of delay, the U.S. Food and Drug Administration (FDA) agreed to allow women aged 18 and older to buy Plan B emergency contraceptive pills at a pharmacy without a prescription.

"This is a historic event in the struggle for women's reproductive health and rights, and a long-overdue victory for science over ideology," says Sharon L. Camp, president and CEO of the Guttmacher Institute. "For the first time we're trusting women to make good reproductive health care decisions by letting them buy their own hormonal birth control, without a prescription."

Over-the-counter sales of Plan B promise to help women prevent accidental pregnancies by offering quicker, easier access to the time-sensitive pills. Research from the Guttmacher Institute suggests that in 2000, use of emergency contraceptives prevented more than 100,000 unintended pregnancies, 51,000 of which would have ended in abortion. Plan B is most effective the sooner it is taken following contraceptive failure, unprotected sex or sexual assault. Emergency contraceptives do not affect an established pregnancy.

Contrary to the recommendations of the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists and other medical groups, however, the FDA decision will still require women younger than 18 to get a prescription for emergency contraception-something likely to delay or even prevent use within the window of time in which the pills are most effective. A number of studies support the safety of the drug for young teens and show that
easier access does not lead to greater risk taking by teens.

There were about 270,000 pregnancies among women and girls younger than 18 in 2002, the vast majority of them unintended. Delays caused by the need to obtain and fill prescriptions (particularly over weekends and holidays) can reduce Plan B's effectiveness and may prevent many women younger than 18 from accessing it in time to avoid a pregnancy.

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American Academy of Pediatrics Releases Policy Statement Supporting Nonprescription Sales of Emergency Contraception to Teenagers [9/2/05]
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=32374

The American Academy of Pediatrics on Thursday released a
policy statement supporting nonprescription sales of emergency
contraception to teenagers and young adults, the AP/Belleville News
Democrat reports (Johnson, AP/Belleville News Democrat, 9/1). The
policy says that EC is safe and should not be confused with
mifepristone as it does not have the ability to disrupt an embryo
already implanted in the uterine lining (AAP policy statement, 9/2).
The statement directs physicians to talk about the drug if they
already are discussing sex with teenage patients, reminding them that
they should be prepared to talk with patients about conflicting
evidence on whether EC could disrupt implantation of a fertilized
egg, as some patients could consider that an abortion (AP/Belleville
News Democrat, 9/1). "Emergency contraception has tremendous
potential to reduce unintended pregnancy rates in teens and adults,"
the statement said, adding, "The AAP continues to support improved
availability of emergency contraception to teens and young adults,
including over-the-counter access and limiting the barriers to access
placed by some health care providers and venues" (AAP policy
statement, 9/2). Wendy Wright, policy director of Concerned Women for
America, said AAP should support getting doctors more involved in
young patients' decisions, adding that they would be less involved if
nonprescription EC sales were allowed. However, Jonathan Klein, chair of AAP's National Committee on Adolescence, said, "The evidence clearly supports that improving access to emergency contraceptives either decreases sexually transmitted diseases or has no effect on them."

Background

AAP last year endorsed a request for FDA to approve nonprescription
sales of EC, but the new policy statement -- which will be published
in the October issue of the journal Pediatrics -- is the first time
the group has provided "detailed guidelines" on EC, according to the
AP/News Democrat (AP/Belleville News Democrat, 9/1). FDA Commissioner Lester Crawford last week said the agency will indefinitely defer a decision on Barr Laboratories' application for nonprescription sales of its emergency contraceptive Plan B and opened a 60-day public comment period on Barr's application. The agency in May 2004 issued a "not approvable" letter in response to Barr's original application to allow Plan B to be sold without a doctor's prescription and in January delayed a ruling on Barr's revised application, which would allow EC to be sold without a doctor's prescription only to women ages 17 and older. Crawford at a press conference last week said that science supported giving nonprescription access to Plan B to women ages 17 and older but added that the application presented FDA "with many difficult and novel policy and regulatory issues," including how to keep girls ages 16 and younger from obtaining the drug (Kaiser Daily Reproductive Health Report, 9/1). In the policy statement, AAP said that both Plan B and Gynetics' EC Preven -- both FDA-approved for prescription sales -- are safe and effective for adolescent use, adding that Plan B is more effective and better tolerated than Preven (AAP release, 9/1). AAP said it is one of more than 60 medical and other groups signing a petition to the FDA stating that EC is "safe, efficacious and easy to administer," all of which are three factors required by FDA for nonprescription medications (AAP policy statement, 9/2). Groups opposed to EC accused AAP of making a political statement with the policy, but Klein denied the allegations (AP/Belleville News Democrat, 9/1).

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"FDA Eases Limits on Plan B Sales"
by Andrew Bridges [AP story 8/24/06]
http://www.examiner.com/a-239942~FDA_Eases_Limits_on_Plan_B_Sales.html

WASHINGTON - Women may buy the morning-after pill without a
prescription - but only with proof they're 18 or older, federal
health officials ruled Thursday, capping a contentious 3-year effort
to ease access to the emergency contraceptive.

Girls 17 and younger still will need a doctor's note to buy the
pills, called Plan B, the Food and Drug Administration told
manufacturer Barr Pharmaceuticals Inc.

The compromise decision is a partial victory for women's advocacy and
medical groups that say eliminating sales restrictions could cut in
half the nation's number of unplanned pregnancies. Opponents have
argued that wider access could increase promiscuity.

The pills are a concentrated dose of the same drug found in many
regular birth-control pills. When a woman takes the pills within 72
hours of unprotected sex, they can lower the risk of pregnancy by up
to 89 percent. If she already is pregnant, the pills have no effect.

The earlier it's taken, the more effective Plan B is. But it can be
hard to find a doctor to write a prescription in time, especially on
weekends and holidays. Hence the push to allow nonprescription sales.

Barr has said it hopes to begin nonprescription sales of Plan B by
the end of the year. The pills will be sold only from behind the
counter at pharmacies - so the pharmacist can check photo
identification - but not at convenience stores or gas stations.

There isn't enough scientific evidence that young teens can safely
use Plan B without a doctor's supervision, Dr. Andrew von Eschenbach,
the FDA's acting commissioner, said in a memo.

But Barr did prove that over-the-counter use is safe for older teens
and adults - and licensed pharmacies are used to checking for proof
of age 18 before selling tobacco and certain other products, von
Eschenbach wrote in explaining the agency's age cutoff.

"This approach should help ensure safe and effective use of the
product," he concluded.

Plan B's maker was disappointed that FDA imposed the age restriction
and pledged to continue working the agency to try to eliminate it.

"While we still feel that Plan B should be available to a broader age
group without a prescription, we are pleased that the Agency has
determined that Plan B is safe and effective for use by those 18
years of age and older as an over-the-counter product," said Bruce L.
Downey, Barr's chairman.

As a condition of approval, Barr agreed to track whether pharmacists
are enforcing the age restriction, by, among other things, sending
anonymous shoppers to buy Plan B. FDA said Barr is to conduct that
formal tracking at least twice in the first year of sales and
annually thereafter, and report stores that break the rules to their
state pharmacy licensing boards.

But Barr also will conduct a national education campaign to raise
awareness of emergency contraception, among both women and health providers.

Nine states - Washington, California, New Mexico, Alaska, Hawaii,
Maine, New Hampshire, Massachusetts and Vermont - already allow women of any age to buy Plan B without a doctor's prescription from certain pharmacies. Proponents of those pharmacy access programs believe that minors won't see any change in those states, because the pharmacist already technically writes a prescription.

The FDA approved prescription-only sales of Plan B in 1999, and the
quest to sell nationwide without a doctor's note began in 2003. That
year, the agency's independent scientific advisers overwhelmingly
backed nonprescription sales for all ages, and FDA's staff scientists
agreed.

But higher-ranking officials rejected that decision, citing concern
about young teens' use of the pills without a doctor's oversight.
Barr reapplied, asking that women 16 and older be allowed to buy Plan
B without a prescription. Then, last August, the FDA postponed a
final decision indefinitely, saying the agency needed to determine
how to enforce those age restrictions.

FDA's handling of Plan B sparked a firestorm: Critics charged that
political ideology had trumped science; a reproductive-rights group
sued to force FDA to settle the issue; and congressional auditors
concluded the agency may have made decisions without reviewing all
the evidence.

Still, nationwide nonprescription sales were widely consider a doomed
issue until last month, when the FDA reversed itself and said it
would reconsider if Barr agreed to an age 18 restriction. That
surprise announcement came on the eve of a Senate committee hearing on whether to confirm von Eschenbach as FDA's new head.

Thursday's decision is expected to remove a Senate roadblock to his
full confirmation.

"While I am glad that the drumbeat for a return to a science-based
FDA has had some positive impact, this decision still represents a
compromise, one that could have the unintended consequence of hurting young women's health," said Dr. Susan Wood, who resigned as FDA's women's health chief to protest the agency's 2005 delay...

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"Vt. Differs from Feds on Plan B for Minors [Associated Press 8/25/06]
http://hosted.ap.org/dynamic/stories/V/VT_MORNING_AFTER_PILL_VTOL-?SITE=RIPRJ&SECTION=HOME&TEMPLATE=DEFAULT

MONTPELIER, Vt. (AP) -- Vermont minors will continue to be able to
get the emergency contraceptive Plan B without a prescription,
despite a Food and Drug Administration ruling to the contrary, a
Planned Parenthood executive said Friday.

The FDA ruled on Thursday that Plan B, also known as "the
morning-after pill," can be sold to women 18 and older without a
prescription, but women 17 and younger must still get a doctor's
prescription to get the drug.

Nancy Mosher, president and chief executive of Planned Parenthood of
Northern New England, said Vermont legislation passed this year set
up a third track for acquiring the drug, aside from getting a
doctor's prescription or purchasing medicine over the counter.

The bill set up a "collaborative practice" process allowing
pharmacists who receive special training to dispense Plan B to women
without a prescription. Physicians would issue the pharmacists
"standing orders" allowing them to dispense the medication to women
who fill out a health screening questionnaire.

Mosher said the FDA ruling means the Vermont law no longer will apply to women 18 and older. Instead, they can go with the FDA ruling
allowing them to buy Plan B over the counter.

Vermonters 17 and younger, unlike their peers elsewhere in the
country, will be able to get the drug without a prescription by
taking advantage of Vermont's new law, she said.

Mosher said Planned Parenthood had distributed Plan B more than
82,000 times since 2000. "We encourage women to have one in their
medicine cabinet in case they have an emergency."

If a woman takes Plan B within 72 hours of unprotected sex, she can
lower the risk of pregnancy by up to 89 percent. Plan B is different
from the abortion pill, RU-486. RU-486, taken in conjunction with
another drug, causes an abortion; Plan B prevents a pregnancy from
happening. If a woman already is pregnant, Plan B has no effect.

Dr. and state Rep. Harry Chen, D-Mendon, who co-sponsored the bill,
said the new law Vermont law had not been implemented yet because
rules governing how it will operate had not yet been written.

"It's very straightforward," Chen said. "This is a very safe
medication. It's over-the-counter in many other countries already."

Information from: Rutland Herald, http://www.rutlandherald.com/

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"Access to Plan B May Have Limited Effect"
by Andrew Bridges [AP story 8/25/06]
http://www.wtop.com/?nid=106&sid=586862

WASHINGTON (AP) - Wider but still restricted access to the
morning-after pill may not have the dramatic effect on unintended
pregnancy and abortion rates touted by some advocates, reproductive
health experts say.

Expanded access should spur increased sales of the pills, called Plan
B, but it probably won't have a major public health impact, they said
Friday.

"That doesn't mean zero, but it will be hard to measure because it
will be so small," said James Trussell, director of the Office of
Population Research at Princeton University. "If you look at the
number of acts of unprotected intercourse on one hand, and the use of
Plan B on the other, it's like a cork on the ocean."

Planned Parenthood hailed Thursday's decision by the Food and Drug
Administration on Thursday to allow nonprescription sales of the
pills to adult women, saying expanded access could prevent up to 1.5
million unintended pregnancies and 800,000 abortions a year.

On Friday, it revised that estimate downward:

"It will not reach that potential," said Jackie Payne, the group's
director of government relations. Payne cited the FDA requirement
that girls 17 and younger still obtain a prescription before buying
the pills, saying that would hinder efforts to reduce the more than
800,000 teen pregnancies a year in the U.S.

Barr Pharmaceuticals Inc. has sold Plan B as a prescription drug
since 1999. Nonprescription pill sales should begin by year's end.
The cost "could be slightly higher" than the $25 to $40 now charged,
said Barr spokeswoman Carol Cox.

Diana Zuckerman, president of the National Research Center for Women & Families, said increased availability will have a big effect on
both pregnancy and abortion numbers.

Zuckerman didn't provide an estimate, but said the cost of the drug
and the nausea associated with it likely will continue to limit its
use to women who are "highly motivated." Zuckerman cited the examples of rape victims and married women who don't want any more children.

About 1.5 million packets of the pills are now dispensed each year,
Barr estimates. Sales should increase further, Cox said, without
providing an estimate.

Use also should increase, though not to dramatic effect. A January
2005 study found that women who didn't have to go through a
pharmacist or clinic to obtain emergency contraception did increase
their use of the pills-- but with no significant reduction in their
pregnancy rate.

That suggests the overall public health impact of removing barriers
could be negligible, because of underlying high rates of unprotected
sex and relative underuse of the pills, according to the Journal of
the American Medical Association study.

"It really doesn't work if it's left in the drawer," Trussell said.

Women who don't use birth control account for about half of all
unintended pregnancies. Whether they would turn to Plan B-- when they didn't have a plan A-- remains unclear.

"That's the population we hope could make better use-- or more
frequent use-- of this particular type of method," said Dr. Douglas
Laube, president of the American College of Obstetricians and
Gynecologists.

Religion also many curtail wider use. A study published this year in
the Journal of American College Health found 51 percent of the
colleges surveyed in the mid-Atlantic region didn't distribute the
pills to students, most commonly for religious reasons, followed by
staffing and funding issues.

On campuses that do offer them, such as the University of Virginia,
the change in Plan B's status won't have much of an effect, said Dr.
Christine Peterson, director of gynecology for UVA's department of
student health. At UVA, female students already can call for a
prescription at any hour of the day, she said.

In 2000, the availability of emergency contraception prevented more
than 100,000 pregnancies, about half of which would have ended in
abortion, according to Guttmacher Institute estimates. There are
roughly 3.1 million unplanned pregnancies in the United States each
year.

FDA Plan B information:
http://www.fda.gov/cder/drug/infopage/planB/default.htm(Copyright

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More information:

http://www.ProChoiceAmerica.org ;

http://www.cnn.com/2006/HEALTH/08/24/morning.after.pill.ap/index.html ;

http://news.yahoo.com/s/ap/20060824/ap_on_go_ot/morning_after_pill ;

http://www.sacbee.com/24hour/ front/story/3357446p-12358159c.html ;

http://www.delawareonline.com/apps/pbcs.dll/article?AID=/20060825/NEWS/608250347/1006/NEWS .