アメリカにおける緊急避妊薬の市販薬化

アメリカのPPFAは、緊急避妊薬の市販薬化の経緯をEMERGENCY CONTRACEPTION History and Accessにまとめています。
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緊急避妊のアクセス改善に向けた取り組みの歴史

フランスでは1999年に市販薬化が実現
In 1999, France became the first country in the world to distribute a brand of EC — NorLevo® — in pharmacies without prescription or parental consent. NorLevo is also distributed free-of-charge along with other methods of contraception at family planning centers (*).
*Ollivier, Debra S. (1999, December 6, accessed 2000,February 22). “Sex Education with a Contraceptive Chaser” Salon.


In January 2000, France's Deputy Education Minister Segolene Royal took the unprecedented step of granting its school nurses the right to dispense EC in both junior and high schools (Daley, 2000; McNeil, 2000). The initiative was accompanied by a nationwide sex education campaign that included information on EC. Provision of EC in schools received widespread support from students, health practitioners, and the union of school nurses (McNeil, 2000; Ollivier, 1999).

However, in July 2000 the Council of State, France's highest administrative court, overruled this decision citing a 1967 law that says hormonal contraception may only be distributed under prescription by pharmacies. The ruling followed a strong show of opposition by the Catholic Church and was lauded by the National Confederation of Catholic Family Associations, which also expressed regret that the court did not take additional steps to reaffirm parental authority in such matters (McNeil, 2000). In October 2000,the French Parliament amended the law to once again allow school nurses to dispense emergency contraception (Kolata, 2000).
Restrictions on the dispensing of EC began to ease in other countries, as well. By 2006, women in 42 other countries, including Albania, Belgium, Canada, Denmark, Finland, India, Israel, Morocco, Norway, Portugal, South Africa, Sweden, and the United Kingdom, could obtain EC without a prescription (Trussell & Wynn, 2006).

In the United States, steps were taken to make EC available over the counter (OTC) or via collaborative practice agreement. In July 1997, an EC collaborative drug therapy agreement pilot project was launched in Washington State. Collaborative drug therapy agreements between pharmacists and prescribers, such as physicians or nurse practitioners, grant the pharmacist the authority to write prescriptions under a set of prescribing protocols. In the first 13 months of the project in the state of Washington, 9,333 EC prescriptions were provided, preventing between 504 and 2,100 pregnancies — about half of which would have ended in abortion (“Pharmacists, Providers..., 1999). Similar programs were established in Alaska, California, Hawaii, Maine, Massachusetts, New Hampshire, New Mexico, and Vermont, and other states considered legislation that would allow pharmacists to dispense emergency contraception without a prescription (Greenberger, 2005; Haddix, 2004; Neergaard, 2005; “Vermont Law…,” 2006).


At public hearings held in June 2000, advocates, including the National Women's Health Network, the Reproductive Technologies Project, and the National Abortion and Reproductive Rights Action League, testified at the FDA in support of reclassifying EC as an OTC drug (“Advocates Testify...,” 2000). Prominent groups such as the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, the American Medical Association, the American Medical Women's Association (AMWA), the American Public Health Association, and Planned Parenthood Federation of America voiced support for making EC available OTC or through a pharmacist (ACOG, 2001; AMWA, 1996; Foubister, 2001; Guttmacher Institute, 2005).


These organizations agreed that improving women's access to EC would not increase their reliance on it as a primary method of birth control. A study found that women who were given EC to take home used other birth control methods at the same rate as women who did not have the pills in their medicine cabinets. Women who had the pills at home were more likely to use EC once. But they were not more likely to use it repeatedly. Women who had home access to EC used the method correctly 98 percent of the time and had fewer unintended pregnancies than those who did not have EC at home (Glasier & Baird, 1998).


On February 14, 2001, the Center for Reproductive Rights filed a petition with the FDA on behalf of more than 70 medical, public health, and other organizations, to grant OTC status to EC (CRR, 2003). No decision was ever issued for this petition. The makers of Plan B filed a second petition in 2003. In December 2003, two FDA advisory panels found that Plan B met the criteria for availability without a prescription, and recommended granting OTC status. Five months later, despite these recommendations, the FDA chose to deny the petition, citing concerns about adolescent use and potential increases in promiscuity. A dozen members of Congress called for the resignation of key FDA officials for denying the OTC petition based on political and ideological — not scientific — reasons. Forty-one members of Congress asked that the FDA reconsider its decision (Kaufman, 2004).


The distributor of Plan B, Teva Women's Health, vowed to continue to work with health organizations and advocated to get the FDA to reverse its decision (Cox, 2004). Numerous studies have since been published that refute the FDA's claim that use of EC would lead to increased promiscuity. These studies demonstrate that while advanced access to EC does increase the chances of using EC, it does not alter sexual behavior or the risk for contracting STIs (Belzer et al., 2003; “Easy EC access ...,” 2005; Marston et al., 2005; “Plan B”, 2005; Raine et al., 2005).


• A study of adolescent mothers examined the impact of giving teenagers EC before they need it. One group of teen mothers received education about EC and was given an advance supply of the pills. Another comparison group received only education about EC. At the six-month follow-up, 83 percent of the group that received the pills used EC, as compared to only 11 percent of the education-only group. The group that received EC was not more likely to report having unprotected sex within the follow-up period (Belzer et al., 2005).


• Another study about advance provision of EC to adolescents had similar findings — the teenagers were more likely to use EC they received, and their use of condoms did not decrease (Harper et al., 2005).


• A 2004 study substantiated the findings of previous studies about advance provision. Adolescent women, aged 15 to 20, were randomized into two groups — one group received EC and education about EC, and the comparison group received education alone. In the first month of the study, the teens in the group that received the pills were twice as likely to use EC as the teens in the comparison group. They also took the pills an average of 10 hours sooner than the teens in the education-only group — an important finding because EC's effectiveness is time-limited. The two groups did not differ in their rates of hormonal contraceptive use at the six-month follow-up. Notably, the group that received the pills was more likely to report condom use at six months than the education-only group (Gold et al., 2004).


The FDA announced that it would, by January 21, 2005, issue its ruling on a subsequent application by Teva Women's Health, which requested OTC sale of EC to women who are 16 and older. The FDA did not meet its deadline (Baer, 2005). On August 26, 2005, while acknowledging that Plan B could be safely sold to women over the age of 17, the FDA announced yet another delay on deciding whether or not to make Plan B available over-the-counter. Citing concerns associated with the difficulty in enforcing OTC age restrictions, the FDA opened a 60-day public comment period to address EC OTC implementation
strategies (Harris, 2005). This comment period ended November 1, 2005 (Harris, 2005; Kaufman, 2005).


On November 14, 2005, the Government Accountability Office (GAO) released its report on Plan B calling the handling of the application by the FDA “unusual.” It found that the high- evel involvement of top FDA officials was atypical, that the decision not to approve the application may have been made before the review was even completed, that Plan B was the only application in the last 10 years that did not receive approval according to the FDA's advisory committees recommendations, that no other FDA-approved contraceptive has age-related marketing restrictions, and that the rationale for not approving the application was novel (GAO, 2005).

In March 2006, Senators Hillary Clinton (D–NY) and Patty Murray (D–WA) brought the fight to bring EC OTC to the forefront of the Senate. They vowed to place a hold on the confirmation hearing for FDA Commissioner-nominee Andrew von Eschenbach until EC was approved for sale OTC.



On July 31, Teva Women's Health received a letter from Dr. von Eschenbach requesting that the company amend its application for the sale of Plan B. As acting commissioner of the FDA, von Eschenbach requested that the age restriction for the sale of Plan B be raised to 18 years, and that Teva Women's Health consider revising the packaging for EC and the location of sale — e.g., in pharmacies, where the age of the consumer could be closely monitored (Tanne, 2006).

On August 24, 2006, the FDA announced its approval of the sale of EC OTC to women and men 18 and older (Barr Pharmaceuticals, 2006). While Planned Parenthood was pleased that the FDA finally took action on this issue, we were troubled by the scientifically baseless restriction imposed on teenagers. Research shows that OTC access to EC does not increase or encourage sexual activity among teens, and better access to proven pregnancy prevention methods, such as accurate sex education and EC, is the best way to reduce the alarming rate of teen pregnancy nationwide.


On March 23, 2008, the U.S. District Court of the Eastern Division of New York ordered the FDA to permit the current manufacturer of Plan B — Duramed Research Inc. of Bala Cynwyd, PA — to make it available to women 17 and older without a prescription (Reuters, 2009). On April 22, 2009, the FDA announced that it would not appeal the court's decision and notified Duramed “that it may, upon submission and approval of an appropriate application, market Plan B without a prescription to women 17 years of age and older” (FDA, 2009). Since ella came on the U.S. market at the end of 2010, it has been available only by prescription (Watson, 2010).


In February of 2011, Teva Women's Health Inc., submitted a supplemental application seeking to remove the prescription-only status for women younger than age 17, expanding over-the-counter access for women of all ages. The Center for Drug Evaluation and Research (CDER) reviewed the application, paying particular attention to whether young teens could understand how to use emergency contraception.



The CDER concluded that Plan B One-Step was “safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted diseases.” Additionally, the data supported a finding that adolescent women could use Plan B One-Step properly without the intervention of a health care provider” (Hamburg, 2011). FDA Commissioner Margaret Hamburg agreed that “there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential,” and the FDA recommended approval of the application (Hamburg, 2011).


However, in a surprising move on December 7, 2011, Health and Human Services Secretary Kathleen Sebelius rejected the FDA's recommendation that Plan B One-Step be available over the counter without age restrictions. Despite the evidence presented, Sebelius stated that “I have concluded that the data, submitted by Teva, do not conclusively
establish that Plan B One-Step should be made available over the counter for all girls of reproductive age. ... It is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age” (Sebelius, 2011).



On April 4, 2013, Judge Edward R. Korman, United States District Judge for the Eastern District of New York, ruled in Tummino v. Hamburg that the FDA must lift age and point of sale restrictions on emergency contraception, citing solid scientific and medical research showing that it is safe and effective in preventing unintended pregnancy (Tummino v. Hamburg Memorandum & Order, 2013).

On April 30, 2013, the U.S. Food and Drug Administration announced that it approved an amended application from Teva Women's Health, Inc. for use of Plan B One-Step without a prescription by women 15 years of age and older, with proof of age required. Additionally, Plan B One-Step will be available in the family planning or female health products aisles, and no longer behind the pharmacy counter (FDA, 2013).


While this was an important step forward to expand access to emergency contraception and prevent unintended pregnancies, the Department of Justice announced the very next day that it would appeal U.S. District Judge Edward Korman's ruling in Tummino v. Hamburg, the decision that lifted the age and point of sale restrictions on emergency contraception.

Finally, on June 10, 2013, the Obama administration announced that would drop its appeal, and on June 10 the FDA approved Plan B One-Step for sale without age or point-of-sale restrictions (Rowan, 2013). Plan B-One Step is now available over the counter in the family planning aisle of drug stores with no age requirement. Other brands of levonorgestrel EC remain behind the counter with pharmacists for purchase by anyone 17 or older without a prescription, or anyone younger than 17 with a prescription. ella requires a prescription at any age.

Planned Parenthood is the leading provider of EC in the U.S. The number of women receiving EC from Planned Parenthood has grown from roughly 17,000 in 1995 to 1,425,746 in 2011 (PPFA, 1997; PPFA, 2012). Planned Parenthood offers all safe, available EC choices, but not every method is available at every Planned Parenthood health center. If you need a prescription for EC, contact your nearest Planned Parenthood health center at 1-800-230-PLAN or at http://www.plannedparenthood.org/.