OTC access to EC blocked — What's next?
Almost 75% of respondents to the Contraceptive Technology Update 2011 Contraception Survey say they provide advance provision of emergency contraception (EC). Such practice might become even more important following Health and Human Services Secretary Kathleen Sebelius' decision to overrule the Food and Drug Administration's (FDA) decision to make Plan B One-Step (Teva Pharmaceuticals, Woodcliff Lake, NJ) emergency contraceptive available over the counter for all women of reproductive age. (See story,below, on readers' views on the importance of advance provision.)
Plan B One-Step originally was approved in 2009 for use without a prescription for females age 17 and older, and as a prescription-only option for females younger than age 17. Teva Pharmaceuticals submitted a supplemental application in February 2011 to remove the prescription-only status for females younger than age 17, which would have made the drug nonprescription for all females of child-bearing age.
The FDA's Center for Drug Evaluation and Research reviewed Teva's application. It determined that Plan B One-Step was safe and effective for use in adolescent females and that adolescent females understood the product was not for routine use and would not protect them against sexually transmitted diseases, according to a statement issued by FDA Commissioner Margaret Hamburg, MD. The data also supported that adolescent females could use the drug properly without the intervention of a healthcare provider. Based on the agency's review of the data, Hamburg was set to move forward with the agency's approval of the nonprescription status.1
However, Sebelius issued a letter on Dec. 7, 2011, registering her disagreement with the FDA's decision, and she stated her authority to execute such a provision under the Federal Food, Drug, and Cosmetic Act. In Sebelius' statement, she said she did not believe enough data were presented to support the application to make Plan B One-Step available over the counter for all girls of reproductive age.2 Sebelius has since said Teva can submit another application with more testing for label comprehension and use among the girls at younger reproductive ages.3
"Because of her disagreement with FDA's determination, the Secretary has directed me to issue a complete response letter, which means that the supplement for nonprescription use in females under the age of 17 is not approved," reads Hamburg's statement.1
Advocates on the move
Women's health advocates have voiced displeasure with the action and questioned the rationale for Sebelius' decision.
"Emergency contraception is more effective the sooner it is used, so it is critical that women of all ages are able to get it quickly and easily, without having to jump through unnecessary hoops," said Sharon Camp, PhD, president and chief executive officer of the Guttmacher Institute in New York City in a statement following the announcement. "Secretary Sebelius' decision to ignore the scientific evidence and keep Plan B One-Step off the shelves of local grocery stores and pharmacies is a huge disappointment."
The American Academy of Pediatrics in Elk Grove Village, IL, the American College of Obstetricians and Gynecologists in Washington, DC, and the Society of Adolescent Health and Medicine in Deerfield, IL issued a joint statement to denounce the action, and the Washington, DC-based Association of Reproductive Health Professionals (ARHP) called it an "unfortunate case of politics trumping science."4
"Emergency contraception is a safe product that is by its nature very time-sensitive," said Michael Thomas, MD, ARHP board chair. "ARHP members support removing barriers that limit access to contraceptive methods that can prevent unintended pregnancies and are adamant that policymakers make their policy decisions transparent and based on the best possible science."
Next stop: courts?
The New York City-based Center for Reproductive Rights is moving to reopen its 2005 lawsuit against the FDA for imposing unnecessary age restrictions on emergency contraceptives. It will seek immediate relief to allow broader access to available drugs. The center also will add Sebelius as a defendant in the reopened case for her role in overruling the FDA's approval of Plan B One-Step.5
The center filed its original petition in 2001 on behalf of more than 70 medical and public health organizations. It asked the FDA to grant over-the-counter status to the original two-pill version of Plan B. When the FDA refused to rule on the petition, the center filed a lawsuit in 2005 in federal court. In 2009, the federal court ordered the FDA to reconsider its decision to limit over-the-counter access, The center filed a motion for contempt against the FDA in November 2010 for failing to follow that order. On Dec. 12, 2011, U.S. District Court Judge Edward Korman found the contempt motion moot; however, he invited the center to reopen its 2005 lawsuit and agreed that the center could add Secretary Sebelius as a defendant.5
"Six years ago, we sued the Bush administration for rejecting science and playing politics with women's health by denying emergency contraception for over-the-counter sale," said Nancy Northup, center president in a statement. "We are stunned to see the same behavior from the Obama administration."6
- Food and Drug Administration. Statement from FDA Commissioner Margaret Hamburg, MD on Plan B One-Step. Accessed at: http://www.fda.gov/NewsEvents/Newsroom/ucm282805.htm.
- Department of Health and Human Services. A Statement by U.S. Department of Health and Human Services Secretary Kathleen Sebelius. Accessed at http://www.hhs.gov/news/press/2011pres/12/20111207a.html.
- Frier S. Sebelius says Teva can reapply to end Plan B pill age limits. Bloomberg Business Week. Accessed at: http://www.businessweek.com/news.
- Association of Reproductive Health Professionals. Reproductive Health Care Providers Outraged at Denial of Over-the-Counter Status for Plan B One-Step. Accessed at: http://www.arhp.org/modules.
- Center for Reproductive Rights. Center for Reproductive Rights Prepares New Legal Challenge to Lift FDA Restrictions on Emergency Contraception. Accessed at http://reproductiverights.org/en/press-room.
- Center for Reproductive Rights. CRR Blasts Health and Human Services Secretary's Intervention to Block FDA Approval of Plan B One-Step for Over-the-Counter, All-Ages Use. Accessed at http://reproductiverights.org/en/press-room/crr-blasts-health-and-human-services-secretary's-intervention-to-block-fda-approval-of-pl.
What do clinicians say about advance provision?
In 2004, 54% of respondents to the Contraceptive Technology Update Contraception Survey said they provided advance provision of emergency contraception (EC), the first year readers were polled on the subject. Seven years later, that percentage has moved up to 74%.
Now that women age 17 and older can obtain EC pills from pharmacies without a prescription, why are clinicians continuing to write advance prescriptions? In today's challenging economy, many women cannot afford them, say readers.
"We are still prescribing Plan B because our patients cannot afford to buy themselves over the counter," says Lisa Friedrichs-Sherard, NP, obstetrics and gynecology nurse practitioner at Comprecare Clinic in San Jose, CA. "The Family PACT (Planning, Access, Care, Treatment) program covers this prescription if we prescribe it."
Jacquelyne Bodden, RN, MS, WHNP-BC, program director and nurse practitioner at SWCAP (Southwest Wisconsin Community Action Program) Reproductive Health Care Center in Platteville, notes a similar circumstance. "We provide EC in our office, and as long as a script is written, it can be covered under Medicaid and some private insurances at lower cost to a patient than buying it over the counter," Bodden explains.
While research indicates that at the population level, advance provision of ECPs has not been demonstrated to be cost-effective,1 many providers see it as a way to help women guard against unintended pregnancy. "I continue to give patients advance boxes of Plan B in the office and write prescriptions for anyone who needs it," states Cathy Smith, ARNP, a family nurse practitioner and clinician in the STD/ Family Planning Clinic at the Skagit County Health Department in Mount Vernon, WA. "It is automatic to supply patients with Plan B as back-up to their chosen method of contraception, unless they decline."
When discussing emergency contraception with patients, remember to counsel on placement of the Copper T380A intrauterine device (ParaGard IUD, Teva North America, North Wales, PA) the most effective way to provide EC. Placement of the IUD within several days of unprotected sex reduces a woman's risk of pregnancy to about 1 in 1,000 and provides her with 10 to 12 years of highly effective, fully reversible contraception if she tolerates her IUD well and wants to continue contraception.2