The University of Pittsburgh Journal of Technology Law and Policy

University of Pittsburgh
School of Law


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[Vol.] PGH. J. Tech. L. & Pol'y [Art. #]


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Thomas Beline, Editor-in-Chief

Elana Kornblit, Executive Editor

George Ernst, Executive Editor

Journal of Technology Law & Policy
University of Pittsburgh School of Law
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Pittsburgh, PA 15260
Telephone: (412) 648-1400


Morality and Technology: “Over-the-counter” easier said than done

by Jessica M. Gulash
University of Pittsburgh School of Law, J.D. expected 2008.
03/01/2007

 

            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, Arkansas, Mississippi, and South Dakota have adopted or expanded refusal clause statutes to cover pharmacists, and eighteen states were considering forty bills that would permit healthcare providers, including pharmacists, to refuse medical care that conflicts with religious or moral beliefs.[14]  Additionally, at least two states, Michigan and Missouri, have introduced bills that would restrict the sale of emergency contraception to prescription-only.[15]  Thus, although Plan B is technically available over-the-counter to all women age eighteen or older, timely or convenient access to the drug is simply not a reality for many women.

            For example, in January, 2005, a Wisconsin mother of six children obtained a prescription for emergency contraception after she experience condom failure during intercourse.[16]  When she attempted to fill the prescription at a Walgreen’s pharmacy, the pharmacist refused to fill the prescription and said, “You’re a murderer.  I will not help you kill this baby.  I will not have the blood on my hands.”[17]  The customer was so traumatized by the experience that she failed to locate another pharmacist to fill the prescription and ended up having an abortion.[18]  While this example only illustrates one instance of a pharmacist refusing to dispense emergency contraception due to religious or moral beliefs, there have been many others.  In another instance, a pharmacist in Texas refused to fill a rape victim’s prescription for emergency contraception on the basis that doing so would violate his moral beliefs.[19]  Although these incidents occurred prior to Plan B being approved for over-the-counter sales, the fact that a woman who wishes to obtain the drug must ask a pharmacist for it likely means that incidents such as this have continued and will continue to take place.

            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 American Academy of Pediatrics, the Guttmacher Institute, and medical scholars have all stated that easy access to emergency contraception would reduce the number of unintended pregnancies and abortions in the United States by the thousands.[26]

            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 Illinois state rule requiring pharmacists at certain pharmacies to provide women with birth control, including emergency contraception, within the same time frame as any other prescription.[27]  The plaintiffs argued that emergency contraceptives are tantamount to abortion and that they hold certain religious beliefs that prohibit them from dispensing such drugs.[28]  Thus, they alleged, the rule violated their First Amendment right to exercise freely their religious beliefs.[29]  The court denied defendants’ motion to dismiss the pharmacists’ claims.[30]  The court noted that even though Plan B is available over the counter, the Illinois rule is still pertinent because women under the age of eighteen must obtain a prescription in order to get Plan B.[31]  The action is still pending and, to date, no court has ruled on the legality of a pharmacist refusal clause as it relates to Plan B or other birth control pills.[32]

            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

 

·         Sexual Health Info Center, Emergency Contraception: http://www.sexhealth.org/birthcontrol/morningafter.shtml

 

·         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 America:  http://www.cwfa.org

 

·         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 Ariz. L. Rev. 469 (2006)

 

 

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).

[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.

[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 Ariz. L. Rev. 469, 472 (2006).

[10] Id.

[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 California, 37 McGeorge L. Rev. 166, 168-69 (2006). 

[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] Id. at 55.

[17] Id.

[18] Id. at 56.

[19] Id.

[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] Id. at 58.

[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] Id. 

[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] Id. at 997.

[29] Id. at 999.

[30] Id. at 1005.

[31] Id. at 997, n.1.

[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.