Two Food and Drug Administration advisory committees voted 23-4 to recommend switching emergency contraceptive Plan B from prescription status to over-the-counter status Dec. 16, 2003. But despite the advisory committees' strong recommendation, the FDA decided to delay any decision about the drug's status until May 21.
Originally, the FDA planned to make a decision by Feb. 20 and, in light of the advisory committees' strong recommendation, its delay has raised suspicions.
Some contraception advocacy groups, for example, suspect political pressures have tainted the FDA's decision.
Those who do not support over-the-counter status for Plan B, however, say legitimate concerns about Plan B still need to be addressed despite the advisory committees' recommendation.
Plan B, also known as levonorgestrel, can reduce the risk of becoming pregnant by 89 percent if taken within 72 hours after unprotected sex or a contraceptive failure.
Although Plan B is sometimes called the morning-after pill, as is RU-486, Plan B and RU-486 are distinct. RU-486 can induce an abortion up to 12 weeks after conception. Plan B, on the other hand, prevents pregnancy by delaying ovulation or by preventing a fertilized egg from embedding in the walls of the uterus and is more effective the sooner it is taken.
Contraception advocates say because time is an important factor in the effectiveness of Plan B, the number of unintended pregnancies that occur each year could be reduced if women could buy Plan B without first getting a prescription from a doctor.
According to the Reproductive Health Technologies Project, three million unintended pregnancies occur every year in the United States.
\Easy access to Plan B will give more women a second chance to prevent unintended pregnancy, flat out, period, full stop that's going to happen,"" RHTP President Kristen Moore said.
""Once more women get the chance to prevent unintended pregnancy we will see the rates of unintended pregnancy go down and we'll see the rates of abortion go down,"" she said.
Although Plan B has no serious side effects, some are concerned that Plan B might negatively influence women's health-seeking behaviors if it is sold over-the-counter.
One of the four FDA advisory committee members who voted against over-the-counter status for Plan B, gynecologist Dr. David Hagar said it is important for sexually active woman to visit their gynecologists and that Plan B might lead to fewer visits if it is sold over-the-counter.
Hagar was further concerned by an actual use study that showed one-third of the women studied did not fully understand that Plan B is intended as an emergency contraceptive and not a regular contraceptive.
""The major reason that women come to see me is regarding contraception. If they have Plan B available we don't have any evidence that they will continue that access,"" Hagar said. ""So we could lose the ability to screen for STDs, to do HIV screening, to do pap smears for HPV screening and check abnormal pap smears and we could lose the opportunity to be able to council those individuals.""
But if Plan B's package insert does not prevent women from using Plan B as a regular contraceptive, it is likely the price will. Two doses of Plan B are required for the contraceptive to take effect and two doses of Plan B cost an estimated $30 to $40.
A second concern, however, has been raised by members of Congress who do not want to see Plan B's status switched to over-the-counter.
In December, the FDA received a letter written by Republican majority whip U.S. Rep. Dave Weldon, R-Fla., and signed by 44 members of Congress asking that Plan B's status not be switched to over-the-counter. The congresspersons are concerned that children might abuse Plan B if it is given over-the-counter status.
""Allowing our schoolchildren to walk next door to the drugstore and pick the morning-after pill off the shelf as often as they want, without any parental consent or involvement and without the advice of and prescription from a doctor is seriously troubling,"" Weldon said in the letter.
According to a report distributed by the Sexuality Information and Education Council of the United States ""...[Plan B] meets the FDA's criteria for over-the-counter status: it does not have serious or harmful side effects; it is not dangerous for individuals with particular medical conditions; and women can self-diagnose their need for it.""
In addition, 70 leading health and medical organizations said they support the advisory committees' recommendations to change Plan B to over-the-counter status. So for some, the FDA's hesitation is bewildering or at least suspicious.
""There was an overwhelming advisory independent review of the data-22,000 pages of data,"" Moore said.
""Somehow, somewhere, the FDA comes back with another set of questions and that followed on a letter from Congress that was signed by 40-plus powerful conservative members of Congress ... and they made claims in that letter, that are not backed up by data. But having the majority whip write that kind of letter had an impact,"" she said.
In addition, some contraception advocacy groups worry the FDA chair, who will make the final decision about Plan B's status, is beholden to political interests.
Anyone who wishes to become the FDA chair must first be nominated by the president and then approved by the members of Congress.
""Politics were brought to bear on this decision,"" Moore said. ""The independent review committee, their decision was overruled by politically appointed officials in the agency.""
Over-the-counter status for Plan B is opposed mostly by people who are against all forms of birth control rather than people who are concerned about Plan B's safety, Moore said.
""The National Right to Life Committee, which is a major pro-life organization, have no public position on this issue,"" Moore said. ""[They] did not submit a testimony, written or oral, because they know this will reduce abortions and it would be hard for them to oppose that.""
The emergency contraceptive pill is available by prescription at University Health Services and Planned Parenthood at a subsidized price, as well as other women's health centers and health care providers in the area.
Since it is not available over-the-counter, students must make an appointment with a doctor in order to receive a prescription for the emergency contraception. However, in some cases, students can call UHS and have a prescription written without an appointment to have in the case of an emergency.
UW-Madison senior Kari Williams said if the morning-after pill were made available over-the-counter, it would be of great benefit to women who have sexual intercourse over the weekend and cannot make an appointment to get a doctor's prescription because doctors' offices are closed.
However, she warned that she has seen many abuse the morning-after pill and stressed the importance of users to learn and understand its ramifications, moreso than the information provided on the package.
""If there is a way to get the education out about the consequences of taking the pill ... I do think it should go over-the-counter,"" Williams said.
However, some students said making the contraceptive available over-the-counter would increase sexual promiscuity and promote irresponsibility and abuse among users.
""I think it promotes irresponsibility,"" an anonymous UW sophomore said. ""If it is absolutely necessary then they should really go to see a doctor because if they've been having sex without protection, they should get tested anyway.""
