OTC access sought for emergency contraception
Could the United States see over-the-counter (OTC) status for emergency contraception (EC)? Washington, DC-based Women’s Capital Corp. says it plans to submit an OTC application for its levonorgestrel-only drug, Plan B, to the Food and Drug Administration (FDA) in late summer 2002.
According to the company, the studies required to support the application are completed, and final data analysis is under way. Women’s Capital Corp. will ask the FDA for priority review of six months or less; if the agency moves forward on the request, a decision could be reached in early 2003.
While the company moves forward toward the OTC request, it is broadening its access through the retail drug distribution network, says Sharon Camp, PhD, company president and chief executive officer. All wholesale drug companies, including regional wholesalers, are stocking Plan B.
"While there are still gaps in coverage, clinicians should have less trouble finding a community pharmacy that regularly stocks Plan B and less trouble getting it stocked when needed," says Camp.
New Zealand goes OTC
Other countries have made the move to remove EC products from prescription-only status. In Scandinavian countries, levonorgestrel-only ECs share drugstore shelf space with other OTC drugs. In France, Great Britain, and a growing number of other European countries, EC is available "behind the counter" from a pharmacist without a prescription; in France, school nurses also can give out the drug.
As of Contraceptive Technology Update press time, women in New Zealand were scheduled to be able to buy EC without prescription from local pharmacists who have undergone special training in providing the drug.1 About 700 pharmacists have undergone training, with plans under way for a second session, says Helen Roberts, MD, a clinical spokeswoman for the Family Planning Association based in Wellington. There are 3,000 pharmacists in New Zealand, and the majority will want to complete the three-hour education program, she predicts.
The training involves a one-hour didactic session looking at EC safety and explanations of how the drug works and how to take it, including the pharmacy guidelines set out by the New Zealand Pharmacy College, says Roberts. Participants then are assigned to small groups to work through various pharmacy scenarios, followed by a final closing session.
EC will continue to be available on prescription in New Zealand from family planning doctors, and women can access the subsidized drug, she adds Roberts. About $30 or $40 will be charged for the drug and a 10-minute consultation by the pharmacist through the pharmacy program.1
Look to study results
To demonstrate that Plan B can be used safely and effectively without a physician’s supervision, Women’s Capital Corp. is analyzing the drug’s use through a variety of investigations. Two that will be reviewed by the FDA in the initial quest for OTC status include a label comprehension study and an actual use study, both conducted by Family Health International of Research Triangle Park, NC. Look soon for publication of the label comprehension study, with results indicating that women regardless of age, ethnicity, or medical literacy readily understand proposed labeling for the product. The actual-use study will be published at a later date, say company officials.
The label study included responses from 663 women in eight U.S. cities. The actual-use study was conducted at five Planned Parenthood clinics and five pharmacies in the Seattle area that are part of the Washington State pharmacy access program.
In addition to these two studies, Women’s Capital Corp. also is examining adolescent use of Plan B through two investigations. A large- scale behavioral study also is under way.
According to Women’s Capital Corp. officials, the following three points should demonstrate Plan B’s ability to meet the FDA’s criteria for an OTC product:
- Since unprotected sex is a self-diagnosable condition, a clinician is not necessary to diagnose the need for EC.
- Plan B should be safe for self-medication since no exams or tests are needed prior to administration, its regimen is appropriate for almost all women, and its side effects, if any, are mild and short term.
- Plan B should be effective when self-administered. All patients take the same dose, the regimen is simple to follow, and labeling already is tailored to self-administration.
Reference
1. Gregory A. Morning-after pill soon selling over the coun-ter nationwide. New Zealand Herald, May 23, 2002. Accessed at www.nzherald.co.nz/storydisplay.cfm?thesection=news&thesubsection=&storyID=2042675&reportID=16.
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