The Food and Drug Administration is expected to make a decision today on whether to make emergency contraception available over-the-counter nationwide.
The pharmaceutical company Barr Laboratories submitted an application to permit the emergency contraceptive "Plan B" to be made available over the counter for people over age 16.
The decision has been the source of significant controversy, as this is the second application Barr has submitted to the FDA in the past nine months.
After an initial appeal for over-the-counter status in May 2004, the FDA, acting against its advisory committees' recommendations, issued a "not approved" letter to Barr Laboratories, citing the lack of research conducted on females under the age of 16.
The letter stipulated that "Before this application can be approved, you would have to provide data demonstrating that Plan B can be used safely by women under 16 years of age without the professional supervision of a practitioner licensed by law to administer the drug."
"If Plan B is approved for nonprescription use, it would dramatically increase access to this product and will represent an important incremental step forward in contraceptive availability in the United States," said Steven Galson, then-acting director of FDA's Center for Drug Evaluation and Research, in an FDA press release in May.
Barr Laboratories then had 10 days to decide whether to file a secondary application, according to the letter from the FDA.
The latest proposal in the supplemental application included provisions for the regulation of sales to persons under the age of 16.
According to the FDA, Plan B, consisting of the synthetic hormone Levonorgestrel, works by two of the same mechanisms as all other hormonal contraceptives: by preventing ovulation -- thus the potential for the joining of a sperm and egg -- or by preventing fertilization if an egg is released.
If either ovulation or fertilization is not prevented, then as a third mechanism, the drug can prevent a fertilized egg from becoming a pregnancy by inhibiting implantation in the uterus.
Opponents of emergency contraception are concerned with this third mechanism by which the drug may act if ovulation and fertilization are not prevented, citing the prevention of a fertilized egg from attaching in the uterus as an abortion itself.
Although the pro-life student group First Right has no official position on emergency contraception, president Kia Lam said "Students are not concerned with what does happen specifically. They just want to prevent pregnancy."
Plan B is not an abortifacient, an agent which causes a medical abortion, and thus cannot disturb an existing, implanted pregnancy, according to information provided by Barr Laboratories. They also state that Plan B should not to be confused with RU-486 -- the so called "abortion pill" -- that does intentionally disrupt pregnancy, resulting in termination.
Approximately 20 unplanned pregnancies are documented each year at Student Health, Director of Gynecology Christine Peterson said.
"It is hard to know how that number will shift" if emergency contraception is available over the counter, Peterson said. "If more students take it, several of those 20 may be prevented. However, many of those 20 pregnancies are a result of not using contraception at all. Whether they choose to use emergency contraception is hard to predict."
Currently under Student Health policy, emergency contraception is offered to students by prescription. A prescription can be obtained by contacting Student Health at anytime and having it filled at the Student Health pharmacy or a local pharmacy.
"Emergency contraception is available 24-7 to U.Va. students, so this is less of a hassle to begin with, compared to women without access to EC," Peterson said.
The unrestricted availability of emergency contraception at the University and other state institutions in Virginia has been met with protest from certain Virginia legislators.
During this year's Virginia General Assembly session, two bills were introduced focusing on the polarized issue. Introduced by emergency contraception opponent Del. Robert Marshall, R-Manassas, House Bill 1813 proposed to free the student health centers at state public universities and colleges from any liability if a student experiences an injury from emergency contraception-related services.
The bill remains in committee.
Also in this session, Del. Scott Lingamfelter, R-Woodbridge, introduced House Bill 1662 which would require minors to notify parents if they accept any one of a range of services relating to pregnancy, sexually transmitted infection treatment or the dispensing of emergency contraception.
This bill was defeated in the House Health, Welfare and Institutions Committee last week. If passed, this bill would have conflicted with federal guidelines if the FDA rules today to make emergency contraception available over the counter to minors age 16 and older.
Kimberly Goumenis, president of the University's Voices for Planned Parenthood, said the organization advocates access to over-the-counter emergency contraception.
"Over the counter availability for EC would be helpful because it will prevent women from worrying about making a doctor's appointment and running against some doctors who oppose the use of EC," Goumenis said.
Goumenis said Voices for Planned Parenthood has attempted to increase awareness about emergency contraception on Grounds, adding that last year the group brought the "EC Van" to the University, which counseled students about the use of emergency contraception.
"If the FDA does not approve over the counter status of the medication, VOX will continue to educate students about safe and reliable venues to obtain EC, such as Planned Parenthood," Goumenis said.
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