New emergency contraception options are here, but how are you to use them?
FDA approves Plan B One-Step and Next Choice
Getting ready to advise your next patient about the importance of emergency contraception (EC)? Be prepared to discuss two new emergency contraceptive products, just approved by the Food and Drug Administration (FDA):
- Plan B One-Step (levonorgestrel tablet, 1.5 mg), a one-dose EC product from Duramed Pharmaceuticals, a subsidiary of Teva Pharmaceuticals in North Wales, PA. The FDA has approved over-the-counter (OTC) access to Plan B One-Step for consumers ages 17 and older. Women younger than age 17 will require a prescription.
- Next Choice (levonorgestrel tablets, 0.75 mg), the generic equivalent to Duramed's first EC product, Plan B, manufactured by Watson Laboratories, a subsidiary of Watson Pharmaceuticals, Corona, CA. The product is currently approved for prescription use only in women ages 17 and younger.
Both products should be available on retail pharmacy shelves now; Watson began shipments in July, with Duramed to distribute product in August. Pricing for Plan B One-Step had not been finalized as of newsletter press time, but the company anticipates the cost to be similar to Plan B, says Teva spokeswoman Denise Bradley. Because companies do not set retail price for drugs, Watson spokeswoman Patty Eisenhaur could not offer a retail cost for Next Choice; however, the product is sold to wholesalers and chain drug stores at a discount to the brand, she states. Average retail price for Plan B is $40.1
The addition of Plan B One-Step will be a boon for women, says David Archer, MD, professor of obstetrics and gynecology and director of the Clinical Research Center at the Eastern Virginia Medical School in Norfolk.
"The previous use of two or more pills taken 12 hours apart often resulted in compliance failure due to side effects or forgetfulness," remarks Archer. "The advantage of one pill is obvious."
Making emergency contraception more convenient with a one tablet approach is certainly a positive change, agrees Andrew Kaunitz, MD, professor and associate chair in the Obstetrics and Gynecology Department at the University of Florida College of Medicine — Jacksonville. Likewise, OTC access for those 17 and older means more females will have easy access to emergency contraception, states Kaunitz.
One clinical trial which compared the two ways of administering Plan B (two 0.75 mg tablets taken within 12 hours apart, or one 1.5 mg dose) verified that both are effective if started within 120 hours,2 but Plan B works best if taken as early as possible, says Anita Nelson, MD, professor in the Obstetrics and Gynecology Department at the David Geffen School of Medicine at the University of California in Los Angeles. Clinics should continue to write prescriptions for emergency contraception, so insurance will help defray the costs, she states.
"We want all of our providers to continue to write prescriptions for emergency contraception, rather than counting on women to go to pharmacies and buy it over the counter in times of need," says Nelson. "That's important for two reasons: No. 1, they are much more likely to take it if they already have it; and, very important, oftentimes insurance will not cover OTC medications, whereas they will cover prescriptions."
Plan B was first approved in 1999 for prescription-use only for women of all ages. In 2006, Duramed Pharmaceuticals won FDA approval to distribute the dual-label version of Plan B, which allowed the drug to be sold "behind the counter," but without a prescription, to women 18 years of age and older, with prescription-only availability for females 17 and younger.
In March, the U.S. District Court for the Eastern District of New York ordered the FDA to reconsider its decision to make Plan B available to 17-year-olds and ordered the agency to review whether to make the ECP available to younger women without prescription. The New York City-based Center for Reproductive Rights had filed the suit in 2005 on behalf of several reproductive health organizations and activists. On April 22, 2009, the FDA announced it would not appeal the district court's decision. "In accordance with the court's order, and consistent with the scientific findings made in 2005 by the Center for Drug Evaluation and Research, FDA notified the manufacturer of Plan B informing the company 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," according to an official statement issued by the agency.3
Plan B and Plan B One-Step are now available without a prescription to females ages 17 and older, according to information from the FDA.4 Both drugs will be available for women younger than age 17 by prescription only.
When Watson Pharmaceutical received its FDA approval in June 2009 for the generic version of Plan B, the approval was issued only for the prescription-only version for those ages 17 and younger. According to the FDA's June 24, 2009, press release, "no generic levonorgestrel product for emergency contraception can be approved for nonprescription use in women ages 18 and older until Aug. 24, 2009, when the marketing exclusivity held by Duramed for the nonprescription use expires."5
Does Watson plan to seek further FDA approval for its product and, if so, what is the projected timeline? According to Eisenhaur, Watson is seeking approval for an over-the-counter generic version of Plan B. "We would anticipate FDA action on our application sometime after Aug. 24, 2009," she states. "Note it is a separate application."
Lydia Stuckey, senior associate for programs and policy at the Washington, DC-based Reproductive Health Technologies Project, says the health advocacy organization is working to fully understand how the approval of the generic product will be implemented at pharmacies, as well as what kind of insurance coverage will be available, particularly if the generic drug is prescribed off-label for females over age 17.
What's to keep providers from writing a prescription for those other than age 17 for the generic EC product? Nothing, says James Trussell, PhD, professor of economics and public affairs and director of the Office of Population Research at Princeton (NJ) University. "Clinicians can write prescriptions for any emergency contraception product," he says.
References
- Dries-Daffner I, Landau SC, Maderas NM. Access to Plan B emergency contraception in an OTC environment. J Nursing Law 2007; 11:93-99.
- Von Hertzen H, Piaggio G, Ding J, et al; WHO Research Group on Post-ovulatory Methods of Fertility Regulation. Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: A WHO multicentre randomised trial. Lancet 2002; 360:1,803-1,810.
- Food and Drug Administration. Updated FDA Action on Plan B (levonorgestrel) Tablets. Press release. April 22, 2009. Accessed at www.fda.gov/NewsEvents/Newsroom.
- Food and Drug Administration. Plan B (0.75mg levonorgestrel) and Plan B One-Step (1.5 mg levonorgestrel) Tablets Information. Accessed at www.fda.gov/Drugs/DrugSafety.
- Food and Drug Administration. FDA Approves Generic Prescription-Only Version of Plan B Emergency Contraceptive for Women Ages 17 and Under. Press release. June 24, 2009. Accessed at www.fda.gov/NewsEvents/Newsroom.
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