What is next for over-the-counter access to emergency contraception?

Advocates push on after FDA refusal, continue to affirm drug’s safety

While the avenue to broader access to emergency contraception (EC) has hit a roadblock with the Food and Drug Administration (FDA)’s initial rejection of over-the-counter (OTC) status for the levonorgestrel-only drug Plan B, the drug’s manufacturer is eyeing two alternative approaches for seeking OTC approval of the drug.

In the May 6, 2004, agency letter, signed by Steven Galson, MD, MPH, acting director of the agency’s Center for Drug Evaluation and Research, the FDA outlined two possible avenues for approval for Plan B’s Pomona, NY-based manufacturer. Barr Laboratories either can:

  • Provide additional data demonstrating that Plan B can be used safely by women younger than 16 years of age without professional supervision; or
  • Supply additional information in support of a submission to allow for the marketing of Plan B as a prescription-only product for women younger than 16 and a nonprescription product for women 16 years and older.1

"While we are disappointed that FDA did not approve our application at this time, we are encouraged by FDA’s suggestions and look forward to working with the agency toward approval of Plan B for over-the-counter use," says Bruce Downey, chairman and CEO of Woodcliff Lake, NJ-based Barr Pharmaceuticals, the parent company of Barr Laboratories. "In the meantime, we remain committed to providing Plan B as a prescription-only product and to increasing awareness among the health care provider community and women of this safe and effective option."

While the company is maintaining a low-key approach while it works with the regulatory agency, the FDA has drawn sharp criticism from a broad cross-section of Congressional members, medical and public health organizations, scientists, and women’s advocacy, health, and religious groups for issuing the nonapprovable decision.

Groups have registered surprise and out rage at the FDA’s decision and pointed to the December 2003 recommendation by two FDA expert advisory panels for approval of OTC status. Members then voted 23-4 to recommend OTC sales of the drug. The FDA typically follows the recommendations of its scientific committees.

In a press statement issued by the Washington, DC-based American College of Obstetricians and Gynecologists (ACOG), president Vivian Dickerson, MD, said, "This decision to ignore an advisory panel’s assessment of the scientific evidence is not only rare, but it gives credence to recent criticisms that political interference is hampering scientific review within federal agencies today."2

"The FDA let politics trump science when it refused to approve Plan B for over-the-counter use," agrees James Trussell, PhD, professor of economics and public affairs and director of the Office of Population Research at Princeton (NJ) University and member of the FDA’s joint committee. "Despite the scientific evidence and findings of independent medical experts, the Bush administration has denied American women timely access to a safe, effective second chance to prevent pregnancy."

In a press release issued by the regulatory agency, the FDA says it based its action on the lack of data surrounding OTC use of Plan B among teens younger than 16.3 According to the FDA, Barr Labs’ application "contained no data in subjects under 14 years of age and very limited data in adolescents 14 to 16 years old."

What if Plan B is made available over the counter to women 16 and older, but remains as a prescription-only drug to those younger than age 16?

"This is probably an unworkable scheme as it has never been done in the United States; therefore, it might take years to establish this two-tiered system," reflects Susan Wysocki, RNC, NP, president and chief executive officer of the Washington, DC-based National Association of Nurse Practitioners in Women’s Health.

What if the drug is made available "behind the counter" — where patients must discuss the drug’s purchase with a pharmacist but need not get a provider’s prescription?

"Although I would prefer neither limitation [prescriptions for under-16-year-old girls or behind the counter’], I would happily give up for the time being and proclaim the OTC, or behind the counter, availability of Plan B for women 16 and older a major step ahead," says Robert Hatcher, MD, MPH, professor of gynecology and obstetrics at Emory University School of Medicine in Atlanta.

Wysocki sees drawbacks in the behind-the-counter approach to the drug, and she cites the lack of confidentiality in most pharmacies.

"It would be very intimidating not only for adult women, but particularly for teens," she says. "Pharmacists for the most part are not trained to handle this type of sensitive counseling."

In California, Plan B is offered behind the pharmacist’s counter, reports Anita Nelson, MD, professor in the obstetrics and gynecology department at the University of California in Los Angeles (UCLA) and medical director of the women’s health care clinic and nurse practitioner training program at Harbor-UCLA Medical Center in Torrance.

Nelson sees financial problems with the "behind-the-counter" approach. While the cost of EC is covered by the state’s MediCal and clinical services program, Family Planning, Access, Care and Treatment (PACT), the charge the pharmacist makes for the required counseling is not, which leaves even women who have insurance with a costly solution, says Nelson. Women who don’t have insurance pay more than $50 for behind-the-counter Plan B, she states.

The California program has yet to reach its full audience; a new survey conducted by the Menlo Park, CA-based Kaiser Family Foundation shows that only one in 10 California women ages 15-44 know about the EC program.4

While the regulatory wheels grind onward, what can providers do to broaden access to EC now?

"It is especially important for clinicians to address safety explicitly," says Felicia Stewart, MD, adjunct professor in the department of obstetrics, gynecology and reproductive sciences at the University of California San Francisco and co-director of the Center for Reproductive Health Research & Policy. "Many people may have gotten the incorrect idea that medication safety is an issue with Plan B." (Use the resources listed on the Washington, DC-based Association of Reproductive Health Professional’s EC Resource Center web site or refer to the contact information below.)

Nelson agrees about raising the awareness level when it comes to safe and effective use of EC. Information geared for adolescent awareness would help in teens’ understanding of the drug, she notes.

"Articles in teen and pre-teen magazines about the FDA decision would be great. Maybe teens would become more aware of Plan B and EC in general," says Nelson. "I have found no more effective method to spin adolescent interest in something than to tell them that they are too young and need to be adults to do it."

References

1. Galson S. Letter to Barr Research Inc. Rockville, MD: Food and Drug Administration; May 6, 2004. Accessed at www.fda.gov/cder/drug/infopage/planB/planB_NALetter.pdf.

2. American College of Obstetricians and Gynecologists. Statement of the American College of Obstetricians and Gynecologists on the failure of the FDA to approve OTC status for Plan B. Washington, DC; May 7, 2004. Accessed at www.acog.org/from_home/publications/press_releases/nr05-07-04.cfm.

3. Food and Drug Administration. FDA Issues Not Approvable Letter to Barr Labs; Outlines Pathway for Future Approval. Rockville, MD. Accessed at www.fda.gov/bbs/topics/news/2004/NEW01064.html.

4. Kaiser Family Foundation. Emergency Contraception Survey Shows Slow Start for California’s New Pharmacy Access Program. Menlo Park, CA; 2004.

Resource

  • The Washington, DC-based Association of Reproductive Health Professionals has developed an Emergency Contraception Resource Center at its web site, www.arhp.org. To access the resource center, click on "Emergency Contraception Over the Counter — Rejected" on the home page of the web site. The resource center has links to the Food and Drug Administration (FDA) letter to Barr Pharmaceuticals announcing the rejection of the over-the-counter (OTC) request, a summary of the December 2003 FDA hearing on the OTC request, and other helpful information, as well as links to sites such as the Emergency Contraception Hotline and Back Up Your Birth Control.