Emergency Contraception OTC The Drug, The Conflict, The Decision

Transcription

1 Emergency Contraception OTC The Drug, The Conflict, The Decision Ann Walker-Jenkins, BA The FDA is requiring that Barr pharmaceuticals and its subsidiary Duramed provide consumers and clinicians with appropriate labeling and education about the product. iin August 2006, the Food and Drug Administration (FDA) approved the emergency contraception (EC) drug Plan B (levonorgestrel) for over-the-counter (OTC) use by women at least 18 years of age (those younger than 18 must obtain a prescription). This decision followed three years of debate, controversy and contention. This article details the history that led up to the final decision and offers resources for nurses seeking more information about Plan B. About EC Plan B, also known as the morning after pill, is the first progestin-only emergency contraceptive and has been shown to reduce the risk of pregnancy by 89 percent if taken within 72 hours of unprotected intercourse (FDA/CDER, 2006a; Duramed Pharmaceuticals, 2006). Some research has found efficacy in preventing pregnancy when EC is used up to 120 hours after intercourse (Hamoda et al., 2004). Plan B does not terminate a pregnancy and should not be confused with the abortifacient drug RU-486. Plan B is a higher dose of regular hormone contraception, which acts by preventing ovulation and fertilization (FDA/CDER, 2006a; Duramed Pharmaceuticals, 2006). Historically, some clinicians have made EC available through off-label prescribing of oral contraceptives in higher doses , AWHONN, the Association of Women s Health, Obstetric and Neonatal Nurses Volume 11 Issue 1

2 At the time of this writing, nine U.S. states provide EC in some pharmacies without an advance prescription Alaska, California, Hawaii, Maine, Massachusetts, New Hampshire, New Mexico, Washington and Vermont. At the time this article was written, Vermont had passed legislation to allow Plan B without a prescription but had not yet implemented the law (Office of Population Research at Princeton University, Association of Reproductive Health Professionals, 2006). Originally, EC was available in two forms in the United States by prescription only: the Yutzpe regimen and Plan B. The former combined large amounts of estrogen with large doses of progestin taken as two doses every 12 hours, and was ultimately taken off the market because of side effects and because it was considered a less effective form of EC. Plan B uses progestin levonorgestrel in two doses or as a single dose and has been associated with fewer side effects than the Yutzpe regimen. It s available in several countries, including the United States, Canada, the UK and France (WHO Task Force on Postovulatory Methods of Fertility Regulation, 1998). Contentious Path to Approval In 1999, the FDA approved Plan B as a safe and effective prescription-only form of EC (FDA/CDER, 2006b). Health care associations including the American Medical Association, American College of Obstetricians and Gynecologists and Association of Women s Health, Obstetric & Neonatal Nurses have supported the OTC use of EC. In 2003, Women s Capital Corporation, later Barr Pharmaceuticals, Inc., filed a request with the FDA seeking OTC status of its drug, Plan B. An Advisory Committee to the FDA was formed to review the evidence and make a recommendation as to whether or not the drug was safe to go OTC. On Dec. 16, 2003, the advisory committee voted 23 to 4 that Plan B be made available for OTC use. The group also voted unanimously that Plan B was safe for OTC use and that there was no evidence suggesting that its availability OTC would encourage people to discontinue use of regular contraception methods (FDA/CDER, 2003). In what would later create a storm of political controversy, the FDA did not take the recommendation of the Advisory Committee, citing that an insufficient amount of data existed regarding the drug s effect on girls under the age of 16. In May 2004, the FDA tabled the recommendation, which essentially rejected the application for Plan B going OTC, until more research on the drug s use in the age group could be obtained. After the rejection, Barr Pharmaceuticals responded in July 2004 by requesting OTC status for girls 16 years of age and older. The idea was to respond to the FDA s complaint that they had insufficient data regarding the drug s effect on girls under the age of 16. This application was delayed a number of times until the current acting FDA Commissioner, Andrew von Eschenbach, sent a letter to Barr Pharmaceuticals asking them to raise the age in their application to 18 and older. On Aug. 24, 2006, after three years of debate, the FDA approved OTC use of the drug in women 18 years of age and older. But prior to the approval, a number of events transpired, and the FDA came under fire. After two years of being the acting commissioner of the FDA, Lester Crawford was nominated for the full directorship. After this nomination, Senators Clinton (D-NY) and Murray (D-WA) threatened to delay his confirmation hearing in the Senate until a decision was made on Plan B. They eventually stopped their delay when Crawford said a decision was expected regarding Plan B by September Crawford was confirmed as commissioner in July In August of that year, Crawford did not make a decision on Plan B but instead opened the issue up for public comment for a 60-day period, disregarding the commitment he had given Congress. Two months after becoming commissioner, Crawford resigned in September 2005, stating personal reasons for the resignation. Andrew von Eschenbach, former director of the National Cancer Institute was then appointed as acting commissioner of the FDA. Crawford s resignation wasn t the only notable resignation during this contentious time. When the FDA opened the 60-day public comment period in August 2005, Susan Wood, director of the FDA Office on Women s Health, resigned. Wood stated upon her resignation, I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional Plan B can only be obtained from licensed pharmacies and health care clinics, and it will be kept behind the counter in pharmacies because it has both OTC and prescription labeling. Ann Walker-Jenkins, BA, is a former legislative associate at AWHONN in Washington, DC. DOI: /j X x February March 2007 Nursing for Women s Health 25

3 staff here, has been overruled (Kaufman, 2005). Frank Davidoff, a consultant and former member of FDA s Nonprescription Drugs Advisory Committee, also resigned in September. Behind the Controversy One of the prominent arguments of those opposed to EC going OTC is that the drug might interfere with the implantation of a fertilized egg, thus touching on the abortion debate. Opponents also think that making Plan B available OTC would increase the number of users of the drug and, therefore, increase the number of fertilized eggs aborted. However, advocates of EC say that the drug is not abortifacient and that the availability of EC instead reduces the need for abortion. According to Planned Parenthood (2006), an estimated 43 percent of the decrease in U.S. abortions between 1994 and 2000 can be attributed to the availability of EC. Other concerns of opponents are the age at which the drug could be obtained and the idea that the drug might impart women with a false sense of security, thus making them more likely to discontinue their regular form of contraception and/or increase risky sexual behavior and make themselves more vulnerable to sexually transmitted infections. Concerns such as these are believed to have spurred the delays of Barr s application. Upon the dismissal of the first application, the FDA cited that it needed to review information on the drug s effect on girls younger than 16 years of age. In addition, the FDA cited that giving a drug dual status making the drug available OTC for some age groups and not for others is atypical for the FDA. Therefore, they needed to institute a useful process to ensure that women of the approved age were the ones obtaining the drug. Proponents of the drug going OTC thought the FDA was acting politically by its repeatedly delaying a decision. They felt that President Bush s administration s stance on abstinence-only education was trickling into Box 1. Timeline: Plan B s Path to OTC Approval July 28, 1999: The FDA approved Plan B as a safe and effective prescription-only emergency contraceptive (FDA/ CDER, 2006b). Feb. 14, 2001: A group of health care and advocacy groups sends a citizen s petition to the FDA requesting they make Plan B OTC (Center for Reproductive Rights, 2001). Feb. 25, 2002: Lester Crawford begins serving as acting commissioner of the FDA. Apr. 16, 2003: Women s Capital Corporation (Later Barr Pharmaceuticals) submits its application to make Plan B OTC. Dec. 16, 2003: The Advisory Committee to the FDA votes 23 to 4 in favor of approving the application for Plan B going OTC (FDA/CDER, 2003). May 5, 2004: The FDA issues a notapprovable letter to Barr Pharmaceuticals (FDA/CDER, 2006b). June 16, 2004: Several Senators request that the GAO research and report on the FDAs review of this drug for OTC use (Anonymous, 2004). July 22, 2004: Barr Pharmaceuticals provides a revised application for dual status, which would make Plan B available OTC only to girls 16 years and older (Barr Pharmaceuticals, 2004). Feb. 15, 2005: President Bush nominates Acting Commissioner, Lester Crawford for the full post. July 15, 2005: Senators Clinton and Murray release their hold on the confirmation of Lester Crawford to be Commissioner of the FDA (Anonymous, 2005). July 18, 2005: Crawford becomes the Commissioner of the FDA. Aug. 26, 2005: Crawford opens the issue of Plan B going OTC to a 60-day public comment period (FDA, 2005). Aug. 31, 2005: Susan Wood, director of the Office of Women s Health at the FDA, resigns. Sept. 23, 2005: Crawford resigns from his post as commissioner of the FDA. Sept. 26, 2005: Andrew von Eschenbach leaves the National Cancer Institute at NIH and becomes acting commissioner of the FDA. Nov. 3, 2005: Representative Maloney and others introduce a bill, H.R. 4229, to require the FDA to make a decision on Plan B. July 31, 2006: The FDA approaches Barr Pharmaceuticals to revise the application for OTC status for women 18 years and older (FDA, 2006). Aug. 24, 2006: The FDA approves Barr Pharmaceuticals application for Plan B going OTC for women 18 years and older. Those younger than 18 will need a prescription. Nov. 12, 2006: Plan B for OTC use begins arriving in drugstores nationwide (Payne, 2006). 26 Nursing for Women s Health Volume 11 Issue 1

4 every agency and creating a political issue in an agency that is supposed to make decisions based on science and not politics. Several Senators requested that the Government Accountability Office (GAO) research and report on the decision of the FDA to deny the application. The GAO revealed a number of interesting aspects regarding the decision and how it differed from other OTC decisions made in the past 20 years. The GAO report said that the deputy director of the Office of New Drugs told them that all birth control pills, including ECPs [Emergency Contraceptive Pills], contain the following class labeling: Safety and effectiveness of [trade name] have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older. Use of this product before menarche is not indicated (GAO, 2005). In addition, of the other 67 proposed prescriptions for OTC review that the FDA had looked at from 1994 to 2004, Plan B represented the only instance where the FDA did not follow the Advisory Committee s recommendations. The FDA maintained that this was an unusual case. The GAO also found that there were no age-related marketing restrictions for any prescription or OTC contraceptives that FDA has approved and that the FDA did not review agerelated restrictions when reviewing the original application for Plan B in 1999 (GAO, 2005). The GAO report also indicated that the need to review adolescents cognitive abilities in order to determine this drug s safety was unique rationale. The FDA disagreed with GAO s findings that high-level officials were unusually involved with the Plan B OTC decision. However, GAO did find that high-level involvement of officials was unusual for an already FDA-approved prescription drug to go OTC, and they also found that FDA officials gave conflicting accounts of when the decision was made (GAO, 2005). This latter issue has led many to believe that the decision was made behind closed doors, perhaps without reference to all the evidence. Conclusions The issues with the OTC use of Plan B will continue to play out, especially since the distribution method will require pharmacists to check patients identification before dispensing Get the Facts BackUpYourBirthControl.org org Barr Pharmaceuticals: Plan B keyproducts/planb.php Duramed Pharmaceuticals: Talking to Patients ForPharmacists/TalkingToPatients/ Default.aspx FDA Plan B Tablets Information infopage/planb/default.htm Pharmacy Access Partnership: Emergency Contraception The Emergency Contraception Web site dose.html the medication. Plan B can only be obtained from licensed pharmacies and health care clinics, and it will be kept behind the counter in pharmacies because it has both OTC and prescription labeling. But opponents still wonder if this drug will inevitably end up in the hands of younger girls. Duramed, a subsidiary of Barr Pharmaceuticals, will monitor the effectiveness of the age restriction. At the time of this writing, it remains to be seen if the method of checking identification will indeed work to ensure that only the approved age group is receiving the drug. The issues with the OTC use of Plan B will continue to play out, especially since the distribution method will require pharmacists to check patients identification before dispensing the medication. February March 2007 Nursing for Women s Health 27

5 In addition, the FDA is requiring that Barr pharmaceuticals and its subsidiary Duramed provide consumers and clinicians with appropriate labeling and education about the product, including a toll-free number where they can obtain information on the drug. Men are also allowed to purchase EC OTC, but the FDA says it will monitor purchasing trends and review this policy if necessary. Advocates for Plan B have wondered if pharmacists will actively avoid handing out an OTC drug. Pharmacists, like other health care providers, hold the right to decline to fill any prescription on moral grounds. Most pharmacies honor those moral concerns by ensuring that another pharmacist is available to fill the prescription. Will pharmacists refuse to hand out EC now that a prescription is no longer required? After years of arguments, resignations and politics, Plan B has been approved for OTC use. Many proponents feel strongly that the drug should be available for women younger than 18 and still feel the FDA caved to politics. Others say its OTC status, even with age restrictions, is helping women gain access to a drug they otherwise could not obtain because of lack of access to health care. Some feel that Plan B is an abortifacient drug and that its OTC use will increase the rate of abortion. Others also feel that selling the drug to adults will inevitably put the drug in the hands of teenagers. Parties on both sides of the issue lost a bit in the fight. Many people say that a good compromise occurs when both sides get up from the table with something. While none of these advocates got exactly what they wanted, they did finally get an answer. However, it appears that the answer doesn t end the controversy. NWH References Anonymous. (2004, June 16). Senator Clinton, Colleagues Call for Plan B Probe. Retrieved September 29, 2006, from ~clinton/news/2004/ html Anonymous. (2005, July 15). Murray, Clinton declare victory in fight over Plan B: Decision on over-the-counter sales of emergency contraceptives will be made by September 1. Retrieved September 29, 2006, from clinton.senate.gov/news/statements/ details.cfm?id=240700&& Barr Pharmaceuticals. (2004, July 22). Barr submits response to FDA in support of over-the-counter status for Plan B emergency contraceptive. zhtml?c=60908&p=irol-newsarticle&i D=595169&highlight Center for Reproductive Rights. (2001, February 14). Center for Reproductive Rights petitions FDA to change emergency contraception from prescription to over the counter. Retrieved September 23, 2006, from org/pr_01_214ecpetition.html Duramed Pharmaceuticals. (2006). You have a second chance. Retrieved September 28, 2006, from com/forconsumers/index.aspx FDA. (2005, August 26). FDA takes action on Plan B: Statement by FDA Commissioner Lester M. Crawford. news/2005/new01223.html FDA. (2006, July 31). FDA announces framework for moving emergency contraception medication to over-thecounter status Duramed and FDA to meet immediately. Retrieved September 29, 2006, from topics/news/2006/new01421.html FDA/CDER. (2003). Joint Session of the Nonprescription Drugs Advisory Committee and the Advisory Committee for Reproductive Health Drugs. Transcript December 16, Retrieved September 18, 2006, from fda.gov/ohrms/dockets/ac/03/ transcripts/4015t1.htm FDA/CDER. (2006a). Plan B: Questions and answers, August 24, Retrieved September 28, 2006, from fda.gov/cder/drug/infopage/planb/ planbqanda htm FDA/CDER. (2006b). FDA s decision regarding Plan B: Questions and answers. Retrieved September 18, 2006, from infopage/planb/planbqanda.htm GAO. (2005, November). Decision process to deny initial application for over-the-counter marketing of the emergency contraceptive drug Plan B was unusual. Retrieved September 23, 2006, from cgi-bin/getrpt?gao Hamoda, H., Ashok, P. W., Stalder, C., Flett, G. M., Kennedy, E., & Templeton, A. (2004). A randomized trial of mifepristone (10 mg) and levonorgestrel for emergency contraception. Obstetrics & Gynecology, 104(6), Kaufman, M. (2005, September 1). FDA official quits over delay on Plan B Women s health chief says commissioner s decision on contraceptive was political. Washington Post Page A08. Retrieved September 18, 2006, from wp-dyn/content/article/2005/08/31/ AR html Office of Population Research at Princeton University, Association of Reproductive Health Professionals. (2006). The Emergency Contraception Web site. Retrieved September 18, 2006, from what-fda-says.html#6 Payne, J. (2006, November 21). For Plan B, a broader reach. Washington Post Page HE01. Retrieved December 2, 2006, from wp-dyn/content/article/2006/11/17/ AR html Planned Parenthood. (2006). The difference between emergency contraception and medication abortion. Retrieved November 28, 2006, from plannedparenthood.org/news-articlespress/politics-policy-issues/abortionaccess/ec-mabortion-6138.htm USDHHS. (2000, September 28). HHS News: FDA approves mifepristone for the termination of early pregnancy. NEW00737.html WHO Task Force on Postovulatory Methods of Fertility Regulation. (1998). Randomised controlled trial of levonorgestrel versus the Yuzpe regimen of combined oral contraceptives for emergency contraception. Lancet, 352, Nursing for Women s Health Volume 11 Issue 1