Finally! Emergency contraception given approval by FDA for nonprescription sale

Sales limited to 18 and older — those younger require prescription

One of the final barriers to availability of emergency contraception (EC) has been toppled with the Food and Drug Administration (FDA) approval of nonprescription sales of the EC drug, Plan B. The drug is manufactured by Barr Pharmaceuticals of Pomona, NY, and marketed by its Duramed subsidiary.

Men and women ages 18 and older will be able to purchase Plan B without a prescription; however, the drug will remain prescription-only for those ages 17 and younger.

Due to the age restriction, Plan B will be sold in retail pharmacy outlets from behind the counter. It will not be available in convenience stores or other retail outlets where it could be sold to younger people without a prescription. Barr Pharmaceuticals says it plans to introduce the dual-status version of the drug before the end of the calendar year.

While EC advocates welcome the over-the-counter (OTC) approval, many continue to question the agency's decision to impose an age restriction on its sales.

"Plan B is safe, effective, and appropriate for over-the-counter use by women of all ages," asserts a statement from the Association of Reproductive Health Professionals. "There is no scientific evidence that warrants age restrictions for access to this drug."1

Women of all ages need timely access to backup birth control, contends the Planned Parenthood Federation of America (PPFA) in a statement issued following the FDA approval.2 In 2005, Planned Parenthood affiliates provided more than 1 million women with EC to prevent unintended pregnancy.

"While we are glad to know the FDA finally ended its foot-dragging on this issue, Planned Parenthood is troubled by the scientifically baseless restriction imposed on teenagers," said Cecile Richards, PPFA president, in the statement. "The U.S. has one of the highest rates of teen pregnancy in the Western world. Anything that makes it harder for teenagers to avoid unintended pregnancy is bad medicine and bad public policy."

The Center for Reproductive Rights is continuing to pursue its lawsuit against the FDA. Depositions released Aug. 3 indicate that the Bush administration sought to unduly influence the agency during the Plan B application review process, according to the center's press statement. In its statement, the legal advocacy group says it plans to subpoena the presidential administration to "explore the extent of this improper influence exerted by the administration over the FDA during the Plan B application review."3

In a statement released following the FDA approval, Barr chairman and chief executive officer Bruce Downey said the company will continue its efforts with the FDA to reduce the age restriction on the OTC use of Plan B.4

Why the wait?

Emergency contraception advocates have questioned the timing of the FDA's announcement, made on the eve of U.S. Senate hearings on the permanent appointment of acting FDA commissioner Andrew von Eschenbach, MD. The FDA issued a nonapprovable letter in May 2004 to Barr Pharmaceuticals' original application. It announced in August 2005 that it would indefinitely postpone its decision to allow nonprescription sales while it gathered public comments on the legality and feasibility of a regulatory scheme that the agency itself recommended that the manufacturer pursue.

However, in July 2006, the agency announced that it had completed its review of about 47,000 comments regarding the switch from prescription to OTC status and asked to meet with officials at Barr Pharmaceuticals to resolve the remaining policy issues associated with the marketing of Plan B as an OTC option. In a letter to the company, the FDA requested that the company amend its application to limit nonprescription sales to those ages 18 and older, rather than the 16-and-older age range included in the initial document.5 Barr submitted a new application with the requested age range and provided more details regarding its proposed marketing, education, distribution, and monitoring program for the OTC version of the drug. According to the FDA, the Convenient Access, Responsible Education (CARE) Program will be aimed at:

  • Providing consumers and health care professionals with labeling and education about the appropriate use of prescription and OTC Plan B, including an informational toll-free number for questions about the drug.
  • Ensuring that drug distribution will be made only through licensed drug wholesalers, retail operations with pharmacy services, and clinics with licensed health care practitioners, and not through convenience stores or other retail outlets where it could be made available to younger women without a prescription.
  • Designing packaging to hold OTC and prescription Plan B, since the drug holds dual OTC/ prescription status. Plan B will be stocked by pharmacies behind the counter because it cannot be dispensed without a prescription or proof of age.
  • Monitoring the effectiveness of the age restriction and the safe distribution of OTC Plan B to consumers ages 18 and older and prescription Plan B to women younger than 18.6

Family planning clinicians will continue to play a major role in educating women about EC, says James Trussell, PhD, professor of economics and public affairs and director of the Office of Population Research at Princeton (NJ) University.

"The biggest reason that women don't use emergency contraception in the United States is not that it is not available over the counter, but that women don't know about it," he says. "Making it go over the counter is not going to magically make people know about it."

Clinicians will need to be vigilant and available to help women, particularly those women under 18 who will need prescriptions for emergency contraception, says Sharon Schnare, RN, FNP, CNM, MSN, clinician at South Kitsap Family Care Clinic in Port Orchard, WA.

Advance EC prescriptions still will be important, says 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 programs at Harbor-UCLA Medical Center in Torrance. "Having an emergency contraception prescription that [a woman] fills in advance and places in a medicine cabinet is superior to searching for a pharmacy that carries the product after she recognizes that she needs it," states Nelson. "A pack of Plan B in the medicine cabinet is worth two behind the counter."

References

  1. Association of Reproductive Health Professionals. ARHP Welcomes FDA Approval of Plan B; Expresses Continued Concern with Age Restriction. Press statement. Aug. 24, 2006. Accessed at: www.arhp.org/media/pressreleases/99-160.cfm.
  2. Planned Parenthood Federation of America. Planned Parenthood Hails Expansion of Plan B Access, but Cites Concerns About Teen Pregnancy. Press release. Aug. 24, 2006. Accessed at: www.plannedparenthood.org/news-articles-press/politics-policy-issues/emergency-contraception-otc.htm.
  3. Center for Reproductive Rights. Depositions Indicate Bush Administration Exerted Political Influence on FDA During Plan B Review Process. Press release. Aug. 3, 2006. Accessed at: www.reproductiverights.org/pr_06_0803FDADepositions.html.
  4. Barr Pharmaceuticals. FDA Grants OTC Status to Barr's Plan B Emergency Contraceptive. Press release. Aug. 24, 2006. Accessed at: phx.corporate-ir.net/phoenix.zhtml?c=60908& p=irol-newsArticle&ID=899120.
  5. Von Eschenbach A. Letter to Duramed Research. Attention: Joseph A. Carrado, M.Sc., R.Ph. July 31, 2006. Accessed at: www.fda.gov/oc/planb/duramed073106.html.
  6. Food and Drug Administration. FDA Approves Over-the-Counter Access for Plan B for Women 18 and Older. Prescription Remains Required for Those 17 and Under. Press release. Aug. 24, 2006. Accessed at: www.fda.gov/cder/drug/infopage/planB/default.htm.