Emergency Contraception known as Plan B is displayed at Planned Parenthood in Springfield, Ill. Credit: AP Photo/Seth Perlman
Last week, those who mustered the intestinal fortitude to watch ABC's "The View" were treated to token conservative co-host Elisabeth Hasselbeck's melt-down over the possibility that an emergency contraceptive might be made available over the counter in the US. "To me it is the same as birthing a baby and leaving it on the street," she blathered.
The screed of the former 3rd runner up on "Survivor: Australia" is a bellwether of how misinformed the public is on this issue and how the politicization of the FDA has permeated our culture.
What set Hasselbeck off was an announcement that the FDA planned to approve over the counter sales of the emergency contraceptive Plan B, if the manufacturer, Duramed Research, Inc., a subsidiary of Barr Pharmaceuticals, altered its application to limit the drug's availability to women 18 years and older. The agency also made the unprecedented move of requiring Duramed to come up with a plan to police pharmacies, assuring "they comply with the restricted distribution plan."
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What made the announcement even more bizarre was that it came one day before the Senate confirmation hearing for Acting Commissioner Andrew von Eschenbach.
Plan B is a higher-than-normal dose of the synthetic hormone progestin, which has been safely prescribed as a birth control pill for more than 35 years. The drug functions mainly by preventing ovulation and does not induce abortion—the abortion pill is a completely unrelated drug, RU-486. Further, there is no scientific evidence that Plan B can cause abortions, or that it can prevent the implantation of an embryo in a woman's uterus. Also, Plan B is available over the counter in 45 other countries.
The American Medical Association recommended that emergency contraceptive medication be made available over the counter in 2000.
Religious conservatives have vigorously opposed Plan B on several grounds. One argument is that access to emergency contraception would result in irresponsible behavior in young women. But, a 2005 study published in the Journal of the American Medical Association clearly showed that access to emergency contraception does not change young womens' sexual behavior. A second objection, this one voiced by von Eschenbach himself, is that there is insufficient data on the safety of the pill when used by teens—hence the decision to limit access to women 18 years or older. However, there are no reports of serious adverse side effects from Plan B in any age group in the 45 countries where it is legal.
Another argument against Plan B is that there is no evidence that it does not occasionally cause abortion or prevent implantation of embryos. This is actually true, but such studies are not possible since we do not experiment on pregnant women. There is however data that shows that it is ineffective in women who have already ovulated before taking the pill. Ignoring the scientific evidence, one opponent even argued that a statutory rapist could use Plan B to "cover up his abuse."
In December 2003, an FDA advisory committee recommended the approval of the application for over the counter status for Plan B by a vote of 23 to 4. One of the opposing members, David Hager, a Bush appointee and practicing, pro-life OB/GYN, was asked by senior FDA brass officials to write a minority report expressing his dissenting opinion. This was an unprecedented move, and neither Hager nor the FDA will say who requested the report.