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Emergency Contraception (EC)
Approval of EC by the Food and Drug
Administration
(FDA) of non-prescription status
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Background:Two brands of emergency contraceptives were originally available in the
U.S. only under a doctor's prescription. Unfortunately, they have to be
taken within a short time of intercourse. There often was
insufficient time for a woman to get an appointment, obtain a prescription, get
the pills and take them within the 72 hour limit. This is particularly critical
on weekends and over holidays -- times when the need for EC often rises. Some doctors refuse to
prescribe these pills for moral reasons. Some women do not have a doctor; others
cannot afford one. A survey conducted by the Kaiser Family Foundation in
the year 2000 found that 11% of ob/gyn physicians had never written a
prescription for emergency contraceptives. 1 The state of
Washington adopted a Collaborative drug therapy agreement that allowed trained pharmacists to dispense emergency contraceptives, starting in 1998. California passed a similar enabling law which came into effect on
2002-JAN-1. Alaska, Hawaii, New Mexico, Maine, Massachusetts, New Hampshire, and
Vermont passed similar legislation in subsequent years. 2 Eventual approval of EC by the FDA:During early 2001, the Center for Reproductive Rights petitioned the US Food and Drug Administration (FDA) to switch emergency
contraception pills to nonprescription status. They did this on behalf of over
60 medical groups including the American Medical
Women’s Association and the American Public Health Association. 3
The Food and Drug Administration organized a committee of experts to
determine whether EC was sufficiently safe and effective to allow its sale
over-the counter. They determined that it met these criteria. Pro-life and conservative Christian groups have wielded a strong influence
over the federal administration. Some have suggested that religious
considerations and political pressure have caused the FDA to deviate from their
normal approval processes for new medications and inhibited women's free access
to and knowledge of EC. In
a highly unusual move that might seriously damage the reputation of the FDA,
its Commissioner, Lester Crawford, overruled the committee's decision. Dr
Susan F Wood, the Assistant FDA Commissioner director of the office of
women's health resigned. She said that she can no longer serve in an agency
that rejects scientific and clinical evidence that has been properly
evaluated. Crawford explained that the FDA was unable to develop a plan to
prevent women under the age of 18 from buying the medication. 4 With the average age of first sexual intercourse being 16 years of age, there
would obviously be many women under the age of 18 who would wish to obtain
EC quickly. Kaiser Network's daily reports announced that:
"In 2006-AUG-24, the FDA approved Barr
Laboratories' Plan B™for nonprescription sale to women and men 18 years and older throughout the
U.S. Barr agreed to send anonymous shoppers into pharmacies to test their
compliance with the age description. In addition, gas stations and
convenience stores are prohibited from selling the EC." 5
In practice, the age limit will probably not present a
significant barrier to sexually active young women under 18-years-of-age. Most
will be able to make an arrangement with an older woman or man who will be able
to buy the pills for them.
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Responses to the FDA decision:Most newspapers' editorials and opinion pieces reacted positively to the
development on 2006-AUG-25. However some opinion pieces by conservative
Christian groups disapproved:
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Philadelphia Inquirer: FDA's decision to limit nonprescription sales of
Plan B to women older than 18 is "about moral preference, not science;
about preserving parents' control over minor children, not medical prudence,"
an Inquirer editorial says. Although the decision "won't please family
planning groups that argued against" age restrictions or "those who
consider Plan B a form of abortion," it is the "best decision the nation
could expect of this administration," the editorial says.
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Seattle Post-Intelligencer: By approving nonprescription sales of Plan B
to women ages 18 and older, FDA has "finally taken a big step to prevent
pregnancies, protect health and reduce" the number of abortions, a
Post-Intelligencer editorial says. However, the "decision included a
compromise based on ideology" because it does not allow for
nonprescription sales among girls ages 17 and younger, according to the
editorial. "At the state and national levels, ideology has inserted
itself into the discussions," the editorial says, concluding, "Science,
the facts and the need to reduce the high U.S. teen birth rate ought to
guide the decisions"
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Maureen Downey, Atlanta Journal-Constitution: The FDA approval "signals
a rare victory for women's reproductive health, which has been a casualty of
the Republican Party's courtship of far right extremists," Downey, a
member of the Journal-Constitution's editorial board, writes in an opinion
piece. However, the "18-and-older rule is a political mollification"
that has "no scientific or health basis," Downey writes, adding that
it also is "unfortunate because it's teenagers who engage in unprotected
sex and have less access to birth control than their peers worldwide."
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David Stevens, Atlanta Journal-Constitution: FDA's decision concerning
Plan B was "influenced by political pressure," Stevens, executive
director of the [conservative] Christian Medical and Dental Associations,
writes in a Journal-Constitution opinion piece. By "allowing both
prescription" and nonprescription sales of Plan B, FDA "appears"
to be creating an "entirely new type of approval that neither has been
authorized by Congress nor subjected to a formal rulemaking process,"
Stevens writes, adding that it is questionable how FDA will be able to
ensure that "this scheme is followed."
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Mary Worthington, Philadelphia Inquirer: While "we can make no
simplistic post hoc correlations here between access to a drug and wholesale
sexual behavior," two European studies have shown after Plan B became
available without a prescription, sexually transmitted infection rates
increased and abortion rates either increased or did not decrease,
Worthington of Generation Life writes in an Inquirer opinion piece. FDA has
"made a mistake in according" nonprescription "status to Plan B,"
Worthington writes, concluding, "Here's hoping the policy is revised or
ended soon" 5 |
 The following information sources were used to prepare and update the above
essay. The hyperlinks are not necessarily still active today.
- Julie Severens Lyons, "Law makes morning-after pill available without
prescription: PHARMACIES WILL BE ABLE TO DISPENSE EMERGENCY CONTRACEPTIVES,"
The Mercury News, 2001-OCT-16, was at: http://www0.mercurycenter.com/ No longer online.
- Judith A. Soon, et al., "Effects of making emergency contraception
available without a physician's prescription: a population-based study,"
Canadian Medical Association Journal, 2005-MAR-29, Page 172-180. It is
online at: http://www.cmaj.ca/
- "Center for Reproductive Rights Petitions FDA to Change Emergency
Contraception from Prescription to Over the Counter," Center for Reproductive
Rights, 2001-FEB-14, at: http://www.reproductiverights.org/
- Gardiner Harris, "Official quits on pill delay at the F.D.A.," New
York Times, 2005-SEP-01, at: http://query.nytimes.com/
- "Kaiser Daily Women's Health Policy Report Summarizes
Editorials on Approval of Nonprescription Plan B Sales to Women Over Age
18," KaiserNetwork, 2006-AUG-28, at: http://www.kaisernetwork.org/
Copyright © 1999 to 2014 by Ontario Consultants on
Religious Tolerance
Originally published on 1999-JAN-13
Latest update: 2014-FEB-21
Author: B.A. Robinson 
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