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Citation Format [Vol.] PGH. J. Tech. L. & Pol'y [Art. #]Contact Information Thomas Beline, Editor-in-ChiefElana Kornblit, Executive EditorGeorge Ernst, Executive EditorJournal of Technology Law & Policy
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Morality and Technology: “Over-the-counter” easier said than doneby Jessica M. Gulash Emergency
contraception, also known as the morning-after pill, consists of increased
doses of certain oral contraceptive pills which women can take to prevent
pregnancy after unprotected sexual intercourse or in cases where the chosen contraception
has failed.[1] Plan B, manufactured by Duramed, a
subsidiary of Barr Pharmaceuticals, Inc., is a progestin-only brand of hormone
pill which has been approved by the Food and Drug Administration (FDA) specifically
for use as emergency contraception.[2] Plan B’s dosing regimen consists of
two pills: the first taken as soon as possible within the first 72 hours of
unprotected sex, and the second taken twelve hours after the first dose.[3] Emergency contraception works by slowing
the speed at which the egg travels through the fallopian tube and by changing
the lining of the uterus so that the egg cannot attach itself to the uteral
wall.[4] When taken within 72 hours of
intercourse, emergency contraception can reduce the risk of pregnancy by 75 to
89 percent.[5] The
FDA approved Plan B as a prescription drug on July 28, 1999.[6] Several years later, a number of
organizations began to push the FDA to approve Plan B for over-the-counter availability.[7] After several years of review and
multiple delays, which included making Plan B’s manufacturer revise its
application for over-the-counter status, the FDA finally approved Plan B for
over-the-counter access for those ages 18 and older.[8]
Pharmacists are required to keep Plan B behind the counter and confirm that the
woman purchasing the drug is age 18 or older before selling it to her.[9] Those ages 17 and under still must
obtain a prescription in order to get Plan B.[10] National distribution of the
over-the-counter version of Plan B began on November 6, 2006.[11] However,
even though the FDA’s approval of Plan B as an over-the-counter drug was
a vital step in expanding access to emergency contraception, there are still
significant barriers which may prevent women from easily accessing the
drug. Even before emergency
contraception was available over-the-counter, some pharmacists compromised
timely access to the drugs by refusing to fill valid prescriptions due to their
own personal beliefs.[12] A number of states currently have or are
considering adopting pharmacist refusal clause statutes, which allow
pharmacists to refuse to dispense certain drugs due to religious or personal
moral beliefs.[13] As of September, 2006, For
example, in January, 2005, a The
reason why some pharmacists refuse to stock or dispense Plan B centers around
their belief that emergency contraception is tantamount to abortion.[20] Others believe that all contraceptive
drugs are abortifacient.[21] Many conservative groups, such as
Pharmacists for Life, believe that emergency contraception is tantamount to
chemical abortion. They argue that
the morning-after pill does not necessarily prevent pregnancy and, in some
cases, kills a developing embryo.[22] Additionally, these groups have
expressed concern that Plan B’s over-the-counter availability will lead
to teenagers becoming promiscuous or having unprotected sex.[23] However,
several prominent medical groups espouse views contrary to those expressed by
conservative groups. For example,
the American College of Obstetricians and Gynecologists (ACOG) and Physicians
for Reproductive Choice and Health (PRCH) have stated that emergency
contraception neither increases promiscuity among teenagers nor prompts women
to abandon regular birth control methods.[24] Additionally, the American Medical
Association (AMA) strongly supported allowing the sale of Plan B over the
counter.[25] ACOG, the American Woman’s Medical
Association (AMWA), the Thus,
despite overwhelming support from the medical community and the fact that it is
available over-the-counter, access to Plan B is controversial and it is unclear
whether pharmacist refusal clause statutes will be upheld if challenged in
court. Indeed, Plan B has already
prompted litigation. In Menges v. Blagojevich, plaintiffs, a
group of pharmacists, challenged an In
sum, although at first glance it appears that the FDA made Plan B easily accessible
to all women by approving it for over-the-counter distribution, it remains to
be seen whether women will, in fact, have proper and timely access to emergency
contraception. For additional information, please
see the following: Plan B
·
Plan
B Official Website: http://www.go2planb.com
·
·
Planned
Parenthood, Emergency Contraception:
http://www.plannedparenthood.org/birth-control-pregnancy/emergency-contraception-4363%20.htm
·
FDA
Information on Plan B:
http://www.fda.gov/cder/drug/infopage/planB/default.htm Advocacy
/ Health Groups
·
Pharmacists
for Life International: http://www.pfli.org/
·
Concerned
Women for
·
Religious
Tolerance: http://www.religioustolerance.org/abo_emer.htm
·
National
Organization for Women: http://www.now.org
·
Planned
Parenthood:
http://www.plannedparenthood.org Cases
·
Menges v. Blagojevich, 451 F. Supp. 2d 992 (C.D.Ill.
2006) Articles
·
Samantha
Harper, “The Morning
After”: How Far Can States Go
to Restrict Access to Emergency Contraception?, 38 Colum. Human Rights. L.
Rev. 221 (2006)
·
Charu
A. Chandrasekhar, RX for Drugstore
Discrimination: Challenging
Pharmacy Refusals to Dispense Prescription Contraceptives under State Public
Accommodations Laws, 70 Alb. L. Rev. 55 (2006)
·
Claire
A. Smearman, Drawing the Line: The Legal, Ethical, and Public Policy
Implications of Refusal Clauses for Pharmacists, 48 Legislation
·
50
States Summary of Emergency Contraception Laws: http://www.ncsl.org/programs/health/ecleg.htm
[1] Sexual Health InfoCenter, Morning
After Pill, at
http://www.sexhealth.org/birthcontrol/morningafter/shtml
(last visited Feb. 26, 2007).
[2] Planned Parenthood, Overview, at
http://www.plannedparenthood.org/birth-control-pregnancy/emergency-contraception/overview-4365.htm
(last visited Feb. 26, 2007).
[3] FDA, Plan B Carton Text, at
http://www.fda.gov/cder/foi/label/1999/21045ppilbl.pdf
(last visited Feb. 28, 2007).
[4] Sexual Health InfoCenter,
supra Note 1.
[5] Planned Parenthood, EC Over the
Counter, at
http://www.plannedparenthood.org/news-articles-press/politics-policy-issues/birth-control-access-prevention/ec-otc-6698.htm
(last visited Nov. 19, 2006).
[6] Food & Drug Admin., Ctr. For
Drug Evaluation & Res., Nonprescription Drugs Advisory Committee (NDAC) in
Joint Session with the Advisory Committee for Reproductive Health Drugs
(ACRHID) Meeting (Dec. 16, 2003) (unpublished manuscript), available at
http://www.fda.gov/ohrms/dockets/ac/03/transcripts/4015T1.doc (last visited
Feb. 27, 2007) at 20-21.
[7] Matthew J. Seamon,
Plan B for the FDA: A Need for a Third Class of Drug
Regulation in the United States Involving a “Pharmacist-Only” Class
of Drugs, 12 Wm. & Mary J. Woman & L. 521, 543 (2006).
[8]
Id.
at 543-45; Press Release, FDA, FDA Approves Over-the-Counter Access for Plan B
for Women 18 and Older – Prescription Remains Required for Those 17 and
Under (Aug. 24, 2006) (available at
http://www.fda.gov/ohrms/dockets/ac/03/transcripts/4015T1.doc).
[9] Clair A. Smearman,
Drawing the Line: The Legal, Ethical, and Public Policy
Implications of Refusal Clauses for Pharmacists, 48
[10]
[11] Jill Daly,
OCT Plan B Marks First Month, Pittsburgh Post Gazette (Dec. 13,
2006), http://www.post-gazette.com/pg/06347/745561-114.stm
(last visited Feb. 27, 2007).
[12] Planned Parenthood, EC Over the
Counter, supra Note 4.
[13] Sophia Rowlands,
Chapter 417: Contraceptives and Conscience Find
Compromise in
[14] Smearman,
supra Note 8, at 473.
[15] Samantha Harper,
“The Morning After”: How Far Can States Go to Restrict Access
to Emergency Contraception?, 38 Colum. Human Rights L. Rev. 221, 222
(2006).
[16]
[17]
[18]
[19]
[20] Charu A. Chandrasekhar,
RX for Drugstore Discrimination: Challenging Pharmacy Refusals to
Dispense Prescription Contraceptives under State Public Accommodations Laws,
70 Alb. L. Rev. 55, 57 (2006).
[21]
[22] Elisabeth Bossom,
Contraception or Deception?, at
http://www.cwfa.org/articledisplay.asp?id=1559&department=CWA&categoryid=life
(last visited Feb. 27, 2007).
[23]
[24] Press Release, ACOG, Medical Groups
Set the Record Straight on Emergency Contraception (May 4, 2004), available at
http://www.acog.org/from_home/publications/press_releases/nr05-04-04-3.cfm
(last visited Feb. 28, 2007).
[25] Daily Women’s Health Policy,
American Medical Association House of Delegates Approves Resolution Supporting
Sale of Plan B Without a Prescription, at
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=24228
(last visited Feb. 27, 2007). [26] Chandrasekhar, supra Note 20, at 65.
[27]
Menges
v. Blagojevich, 451 F. Supp. 2d 992, 996 (S.D.Ill. 2006).
[28]
[29]
[30]
[31]
[32] For a detailed analysis of whether and to what extent a state may restrict access to Plan B and other emergency contraceptives, see Harper, supra Note 15. |