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The wheels are in motion for moving emergency contraceptive pills (ECPs) to over-the-counter status, as study protocols are being designed to evaluate the use of the drug without a prescription.
The Bellevue, WA-based Women’s Capital Corp., marketer of the levonorgestrel-only ECP Plan B, has met with Food and Drug Administration (FDA) officials to review study protocols the company will undertake to support the switch from prescription to over-the-counter (OTC) status for Plan B, confirms Sharon Camp, PhD, Women’s Capital Corp. president.
The studies include the two normally required for an OTC switch: a label comprehension study and an actual use study, which mimics OTC use, Camp explains.
"The actual use study will be done in Washing-ton State pharmacies now dispensing Plan B without a prescription — a sort of living laboratory," says Camp. "The company also is doing some additional studies addressed to the broader behavioral questions about which the FDA and others have expressed concern, namely the likelihood
of repeated use, special problems related to use
by young teens, the impact on use of regular contraception, and specifically the possibility of increased HIV/sexually transmitted diseases risk if couples use condoms less consistently."
Data key for decision
The FDA’s decision will be based in large part on the actual use study that will take place in Washington State pharmacies, says Camp.
"For study subjects, we will take the pharmacist out of the loop," she explains. "Women will be consented for the study, then given the prototype OTC product, which will look very much like Plan B does now."
There will be no screening or counseling involved with the drug’s distribution, says Camp. Participants will undergo follow-up at various intervals to assess such issues as contraindicated and incorrect use, she states.
"Given FDA’s suggested revisions to both study protocols, we have been delayed by a couple of months and will probably not be able to submit the study results until early next year," Camp reports. "We expect to ask for priority review status and would hope for approval sometime in 2002."
A petition has been filed on behalf of more than 60 medical groups to change the status of emergency contraceptive pills from prescription to OTC. The legal document has been filed with the FDA by the New York City-based Center for Reproductive Law and Policy.
"Because emergency contraception poses no known health risks, has minor side effects, and
can be taken in two simple, identical doses without medical supervision, it meets all the criteria necessary for over-the-counter status," states Bonnie Scott Jones, staff attorney with the Center. "Most importantly, easy access to emergency contraception would, in fact, protect public health by eliminating millions of unwanted pregnancies and abortions."
The FDA has 180 days to respond to the petition, which was filed on Feb. 14, says Linda Robayo, a spokeswoman for the center. The agency does not have to issue a decision in this time period; it can acknowledge its receipt and delay its decision for as long as it wishes, Robayo explains.
How can proponents of emergency contraception(EC) show their support for the petition?
"If they are a medical or health public group, they should contact us about signing on as petitioners," says Scott Jones. "If not, they should try and do press [stories] on the issue or local lobbying." (See the resource box on p. 53 for contact information.)
The Washington, DC-based American College of Obstetricians and Gynecologists (ACOG) has issued new and revised documents on the safety and availability of EC.
The group supports making EC available to women OTC in a designated (prepackaged) product and has issued a formal statement on the subject.1 It also has issued a revised practice bulletin, which updates its recommendations to physicians regarding the safety and efficacy of prescription EC.2
The revised bulletin includes charts on how
to combine common prescription oral contraceptives in dosages that provide EC and has added information on two EC designated products: Preven (from Gynétics of Belle Mead, NJ) and Plan B. To increase access, ACOG suggests physicians may wish to offer patients an advance prescription for EC during routine gynecologic visits.
Get the word out
It will be important for EC proponents to address the public concerns about OTC availability, says Camp.
"Research to date suggests that public opposition to the switch could be significant without more educational efforts," Camp notes. "If public opposition is effectively mobilized by the religious right over issues such as access by minors, the application might be denied or held up indefinitely."
Increased education is going to have to go hand in hand with moving EC to the forefront in terms of public awareness, says James Trussell, PhD, professor of economics and public affairs, faculty associate of the Office of Population Research, and associate dean of the Woodrow Wilson School of Public and Interna-tional Affairs at Princeton (NJ) University. The Office of Population Research and the Washington, DC-based Reproductive Health Technologies Project operate the Emergency Contraception Hotline [(888) NOT-2-LATE], a national toll-free, automated, confidential hotline available 24 hours a day in English, Spanish, and French, as well as an affiliated web site (not-2-late.com).
"The clinical bottleneck in the United States is that currently clinicians think EC is safe and effective and are waiting for women to come and ask for it, while women don’t know to come and ask for it," says Trussell. "We’re not going to get anywhere much toward solving that problem just by making it available over the counter."
1. American College of Obstetricians and Gynecologists. Statement Supporting the Availability of Over-the-Counter Emergency Contraception. Washington, DC; 2001.
2. American College of Obstetricians and Gynecologists. Emergency Oral Contraception. Washington, DC; 2001. n
Medical groups who wish to join the petition to move emergency contraceptive pills to OTC status should contact:
• Center for Reproductive Law and Policy, 120 Wall St., New York, NY 10005. Telephone: (917) 637-3600. Fax: (917) 637-3666. Web: www.crlp.org.
For more information on emergency contraceptive pills and OTC status, contact:
• Sharon Camp, PhD, Women’s Capital Corp., 1990 M St. N.W., Suite 250, Washington, DC 20036. Telephone: (800) 330-1271. E-mail: email@example.com.
• Linda Robayo, Center for Reproductive Law and Policy, 120 Wall St., New York, NY 10005. Telephone: (917) 637-3605. Bonnie Scott Jones may be contacted via Robayo.
• James Trussell, PhD, Office of Population Research, Wallace Hall, Princeton University, Princeton NJ 08544. Telephone: (609) 258-4810. Fax: (609) 258-1418. E-mail: trussell@princeton. edu.