Re: Morning After Pill
I'll never understand how the President of the U.S. ends up taking all the heat on these issues when he doesn't even decide them. I wonder if some of you guys actually understand how our government works...Do you even know how many Senators your state has?...
BTW, my understanding of the stem cell issue is that it will not receive federal funding, i.e. our government will not take a side regarding its morality. It is legal.
You also missed the age requirement of 18 and ID for "Plan B", which is restricted to sale BTC by health professionals only...
Instead of reading the news at The Baptist Press, read this and operate from a position of knowledge. Geez...
For several decades, ECPs have been prescribed for women to reduce the risk of pregnancy after unprotected intercourse in cases of unanticipated sexual activity, contraceptive failure, or sexual assault. The first documented case of emergency postcoital contraception was published in the 1960s when physicians used this method to prevent pregnancy in a survivor of sexual assault (Ellertson, 1996). As recently as the early 1990s, nearly one-third of ECP prescriptions were for rape survivors (Grossman & Grossman, 1994). By the end of the decade, ECPs were widely recognized as a safe and effective method for all women at risk of unintended pregnancy (KFF, 1997). At one time, ECPs were commonly known by the misnomer "morning-after" pill. The term, "morning-after" pill, is incorrect, however, because treatment
* involves more than one pill
* does not need to occur on the "morning after"
* should not be confused with medical abortion the "abortion" pill because ECPs cannot terminate an established pregnancy
The ECP regimen first approved by the U.S. Food and Drug Administration (FDA) is called the Yuzpe Regimen, named for Canadian Professor A. Albert Yuzpe who, in 1974, published the first studies demonstrating the safety and efficacy of ECPs. The Yuzpe regimen consists of combined oral contraceptive pills that contain the hormones estrogen and progestin taken in two doses, 12 hours apart. Studies have shown ECPs reduce the risk of pregnancy when started within 120 hours (five days) of unprotected intercourse, but the treatment is more effective the sooner it begins ("FDA Approves...," 1999; Rodrigues, et al., 2001; Van Look & Stewart, 1998 ).
Before the FDA's approval, the Yuzpe regimen had been approved by the drug regulatory agencies of the United Kingdom, Germany, Sweden, Switzerland, and New Zealand (FDA, 1997). Another type of ECP, which contains a single progestin, levonorgestrel, first became available in Eastern Europe under the name of Postinor (Guillebaud, 1998 ) . Pharmaceutical companies have since introduced such products in other countries, including the U.S., where the progestin-only ECP is known as Plan B.
Emergency Contraception Was Once Called America's "Best-Kept Secret"
Before September 1998, no dedicated ECP product had been approved, labeled, and marketed in this country, and emergency hormonal contraception was available only through "off-label" use of oral contraceptive pills. Off-label use of approved medications is a common and legal practice, and some hospital emergency rooms, family planning clinics, and university health centers began providing women with emergency contraception in this way. Despite decades of safe and effective use of ECPs around the world, the off-label status of ECPs concerned some providers in the U.S. who were fearful of legal liability. In this environment, physicians were reluctant to educate women about emergency contraception, and because there was no commercial advertising, most women knew nothing about it. In reproductive health circles, emergency contraception became known as "the nation's best-kept secret" (Hatcher, et al., 1995).
Major Pharmaceutical Companies Showed Little Interest in Marketing ECPs
In November 1994, in an attempt to bring ECPs into the medical mainstream, the Center for Reproductive Rights (CRR), formerly known as the Center for Reproductive Law and Policy (CRLP), filed a citizen petition with the FDA on behalf of a coalition of leading medical and public health groups, including Planned Parenthood of New York City. The petition asked the FDA to require that manufacturers include information about emergency contraceptive use in the product packaging of certain formulations of birth control pills ("Groups Want New Labels...," 1994).
On February 14, 1996, the national Emergency Contraception Hotline (1-888-NOT-2-LATE) was launched by the Reproductive Health Technologies Project and Bridging the Gap Foundation, Inc. It offered callers information about ECPs and a referral list of physicians and clinics across the country that were willing to prescribe them (OPR, 1996). But the off-label status of ECPs continued to deter physicians and clinics from promoting the service, and most women still remained in the dark about ECPs. Meanwhile, the FDA approached several large pharmaceutical companies with a request that they market ECPs, because there was a clear need by the public for emergency contraception. But the manufacturers refused because they were concerned with liability issues and what they saw as limited profit potential (Kolata, 1998; Silverman, 1998 ).
ECPs Receive FDA Approval and Efforts Are Made to Improve Women's Access
The FDA was unwilling to force the pharmaceutical companies to add emergency contraceptive instructions to oral contraceptive packaging and labeling. But in February 1997, the FDA did take a step that is most unusual in the absence of an application from a drug manufacturer. In response to the CRR citizen petition, the FDA issued an official notice in the Federal Register declaring common regimens of emergency contraception to be safe and effective. The FDA also said it would accept applications to manufacture and market ECPs without requiring expensive new drug trials, because the safety and efficacy of emergency contraception had already been demonstrated (FDA, 1997).
* In July 1997, the Collaborative Agreement ECP Pilot Project was launched in Washington State by a coalition of health care providers and advocacy organizations, led by PATH (Program for Appropriate Technology in Health). This innovative pilot project enabled thousands of women in Washington to receive ECPs and instruction for correct use of the medication, directly from their pharmacists without first going to a doctor. More than 800 pharmacists and pharmacy students received training for prescribing and counseling about ECPs. The training enabled them to enter collaborative drug-therapy agreements with prescribing clinicians, and gave them the authority to dispense ECPs directly to women (PATH, n.d. ). In the first 13 months of the project, 9,333 ECP prescriptions were provided, preventing between 504 and 2,100 pregnancies, about half of which would have ended in abortion. ("Pharmacists, Providers...," 1999).
* Similar programs have since been established in Alaska, California, Hawaii, Maine, Massachusetts, New Hampshire, and New Mexico (Greenberger, 2005; Neergaard, 2005). In September 2005, Massachusetts became the eighth state to establish an EC Collaborative Practice agreement. With enough votes to override Governor Mitt Romney's (R) veto of July 25, 2005, the state House and Senate resoundingly endorsed a Massachusetts bill that will not only allow for ECPs to be dispensed by a pharmacist without a prescription, but will also require that ECPs be made available in hospital emergency rooms for sexual assault survivors (Belluck, 2005; Greenberger, 2005). This bill should take effect by mid to late December 2005.
More Options for Women Needing ECPs Are Now Available
In September 1998, the FDA approved the application of Gynétics, Inc. of Belle Mead, NJ, to market America's first dedicated ECP product, the PREVEN Emergency Contraceptive Kit. PREVEN consisted of Yuzpe regimen ECPs, a pregnancy test, and instructions. The approval of PREVEN, however, did not mean the end of off-label use of oral contraceptive pills as ECPs. Some providers continue to prescribe oral contraceptive pills for emergency use, and for some women, the ECP dosage becomes the beginning of daily, non-emergency oral contraceptive use. The launch of PREVEN represented the first commercial ECP advertising to American women. As of 2004, PREVEN is no longer being manufactured. Limited supplies of PREVEN are still available it is still considered to a safe and effective ECP product.
In July 1999, the FDA approved the first progestin-only ECP available in the U.S. Produced by Barr Pharmaceuticals, Inc. of Woodcliff, NJ, Plan B contains only one hormone, the progestin, levonorgestrel ("FDA Approves...," 1999). A World Health Organization-supported study has found that the levonorgestrel regimen is more effective and has fewer side effects than the Yuzpe regimen (Task Force on Postovulatory Methods of Fertility Regulation, 1998 ).
International Efforts to Increase Availability of ECPs
In January 2000, France's Deputy Education Minister, Segolene Royal, took the unprecedented step of granting its school nurses the right to dispense ECPs in both junior and high schools (Daley, 2000; McNeil, 2000). The initiative was accompanied by a nationwide sex education campaign that included information on emergency contraception. Provision of ECPs 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 emergency contraception are easing in other countries as well. Women in 42 countries, including Albania, Belgium, Canada, Denmark, Finland, India, Israel, Morocco, Norway, Portugal, South Africa, Sweden, and the United Kingdom, can obtain emergency contraception without a prescription (Trussell & Wynn, 2006).
American Women Need Greater Access to ECPs
Although options for and information about ECPs have increased, further efforts are needed to improve women's access to this important backup method of birth control. Some pharmacists and religious hospitals refuse to provide ECPs, even for women who have been raped. Furthermore, anti-choice, anti-family planning organizations have used scare tactics to launch public misinformation campaigns about ECPs, making false claims about their safety and efficacy.
Protection is required for women seeking contraception from medical professionals who want to deny them access on religious grounds. Educational campaigns are needed to combat anti-choice misinformation and to ensure that both the public and legislators know the truth about emergency contraception its safety, efficacy, and potential public health benefits. Approximately 1.7 million unintended pregnancies and 800,000 abortions could be prevented each year by the widespread use of ECPs in the U.S. (Glasier & Baird, 1998 ) .
One important step to increasing access to ECPs is making them available over-the-counter in the U.S., as they are in many other countries. 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 ECPs as over-the-counter drugs ("Advocates Testify...," 2000). Prominent groups such as the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, the American Medical Association, and the American Public Health Association have since voiced support of making ECPs available over-the-counter (ACOG, 2001; AGI, 2005b; Foubister, 2001).
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 over-the-counter status to ECPs (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 meets the criteria for availability without a prescription, and recommended granting over-the-counter status. Five months later, despite these recommendations, the FDA chose to deny the petition, citing concerns about adolescent use and increases in promiscuity. A dozen members of Congress called for the resignation of key FDA officials for denying the over-the-counter 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, Barr Pharmaceuticals, Inc., vowed to continue to work with health organizations and advocates to get the FDA to reverse its decision (Cox, 2004). In 2005, new studies rebutted the FDA's claim of increased promiscuity, finding that while advanced access to EC does increase the chances of using EC, increased access does not alter sexual behavior or the risk for contracting STIs ("Easy EC access...", 2005; Harper, et al., 2005; Marston, et al., 2005; "Plan B", 2005; Raine, et al., 2005).
By January 21, 2005 the FDA was supposed to issue its ruling on Barr Pharmaceuticals, Inc.'s subsequent application, requesting over-the-counter status of EC for women who are 16 and older. The FDA did not meet this 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 the over-the-counter age restrictions, the FDA has opened a 60-day public comment period to address EC over-the-counter implementation strategies (Harris, 2005).
