Bulletin: Emergency contraception moves closer to over-the-counter

This month may well mark a milestone in women’s health if the Food and Drug Administration (FDA) follows the recommendation of two of its expert advisory committees to approve the over-the-counter (OTC) sale of Plan B, the levonorgestrel-only emergency contraceptive (EC).

In a joint meeting of the FDA’s Reproductive Health Drugs and Nonprescription Drugs Advisory committees, members voted 23 to 4 to recommend OTC sale of the drug. The final decision rests with the FDA’s commissioner, Mark McClellan, MD, MPH. While the FDA doesn’t always follow its advisory panels’ recommendations, it would be "surprising" if it did not in this case, says James Trussell, PhD, professor of economics and public affairs and director of the Office of Population Research at Princeton (NJ) University.

"There wasn’t much opposition, and there was considerable support" for making the EC drug available on retail pharmacy shelves, says Trussell, who was a member of the FDA joint committee.

Barr Laboratories of Pomona, NY, which is acquiring Plan B from the Washington, DC-based Women’s Capital Corp., says it is working within the FDA approval process to secure OTC status for the drug.

"While we were extremely pleased with the positive recommendation of the joint FDA Advisory Committee, we realize that that is just the first step," states Carol Cox, Barr Lab’s vice president of investor relations and corporate communications. "We are expecting to meet with the FDA and anticipate a decision on our application in late February 2004."

Review the science

Evidence was presented at the Dec. 16, 2003, meeting by FDA staff members, Barr Labs, and the public. Members of the FDA panel included experts in a variety of fields, including obstetrics and gynecology, pediatrics, pharmacology, and internal medicine, with varying views on birth control.1

The company presented findings from clinical study data on nearly 11,000 women who have taken the pills used in Plan B after sex to prevent pregnancy, including results of its label comprehension study2 and the OTC actual-use study, which was designed to mimic OTC distribution.3 Study data indicate that women can understand the label and take the drug as intended, Barr Labs contends.

The company also submitted an overview of an extensive education program it plans to aim at physicians and other health care professionals, as well as an array of educational materials that will be available for women who have questions about Plan B or its appropriate use. The materials include consumer-friendly labeling, an informational web site, and a 24-hour hotline that will connect consumers directly with trained health care professionals to answer any questions about the drug.

In making their recommendation for the OTC switch, committee members called for clearer wording on the package so that women understand the drug should be used as soon as possible after unprotected sex; know that as with other hormonal contraceptives, it does not protect against sexually transmitted diseases; and recognize it as a backup contraceptive, and not an alternative to routine birth control.4

Seventy leading health and medical organizations, including the Association of Reproductive Health Professionals and the American College of Obstetrics and Gynecology, both based in Washington, DC, as well as the Chicago-based American Medical Association have pledged support for OTC access for Plan B.

Opposition also has been voiced to the OTC switch. Forty-four members of Congress have issued a letter to the FDA asking for continuance of prescription-only status. They said that sale without a prescription would make Plan B "as accessible to our nation’s teen-age daughters as aspirin or hair spray."5 (Editor’s note: Read the signed letter at the Republican Study Committee’s web site, located at Congressman John Shadegg’s web site: johnshadegg.house.gov. Click on "Republication Study Committee," "Conservative Activity," then "Letter to the FDA.")

"Although we recognize that EC represents a safe and effective post-coital approach to contraception, currently restricted access means that too few U.S. women take advantage of it," states Andrew Kaunitz, MD, professor and assistant chair in the obstetrics and gynecology department at the University of Florida Health Science Center/Jacksonville. "OTC status for Plan B would go a long way toward increasing EC access, therefore reducing unintended pregnancy and abortion."

How will providers’ tasks change if EC becomes available OTC?

"Consider the role that clinicians currently have to educate patients about the proper use of condoms and spermicides. These products have always been over the counter," observes Susan Wysocki, RNC, NP, president and chief executive officer of the Washington, DC-based National Association of Nurse Practitioners in Women’s Health. "This role to educate about awareness and appropriate use should not be different for Plan B if it goes over the counter."

No matter what decision is reached by the FDA, be prepared for more questions about EC, says Wysocki. The publicity surrounding the FDA committees’ decision has increased the public’s awareness of EC; look to that publicity to translate into many more inquiries by women and couples about the use of EC, she says.

"I hope we are bombarded with questions about Plan B," says Sharon Schnare, RN, FNP, CNM, MSN, clinician at South Kitsap Family Care Clinic, Port Orchard, WA. "We are beginning a new age of independence for women, and we should welcome the questions we receive." 

References

1. Kolata G. A contraceptive clears a hurdle to wider access. The New York Times, Dec. 17, 2003. Accessed at: www.nytimes.com.

2. Raymond EG, Dalebout SM, Camp SI. Comprehension of a prototype over-the-counter label for an emergency contraceptive pill product. Obstet Gynecol 2002; 100:342-349.

3. Raymond EG, Chen PL, Dalebout SM. Actual-use’ study of emergency contraceptive pills provided in a simulated over-the-counter manner. Obstet Gynecol 2003; 102:17-23.

4. Rubin R. Non-prescription morning-after’ pill backed. USA Today, Dec. 16, 2003. Accessed at: www.usatoday.com/news/health/2003-12-16-fda-pill_x.htm.

5. Richwine L. Access to morning-after pill stirs debate. Reuters, Dec. 16, 2003. Accessed at www.reuters.com/newsArticle.jhtml?type=healthNews&storyID=4003183.