FDA stuck on possibility of over-the-counter contraceptive pill
June 25, 2003
Anti-abortion and abortion rights groups are up in arms over a petition making Emergency Contraception (EC), an over-the-counter pill.
For almost two-and-a-half years, the Food and Drug Administration has failed to resolve the petition concerning EC, also known as the morning after pill, causing turmoil on both sides of the abortion debate.
On Feb. 14, 2001, a citizen’s petition signed by over 70 organizations, including the American Public Health Association, was sent to the FDA to consider making EC available to women without a prescription from a physician, according to Medscape Medical News, www.medscape.com.
Since then, the FDA has made no move on the petition due to what they call serious issues, said Dr. David A. Grimes in an interview with Medscape Medical News.
The FDA was unable to be reached for comment.
Marvin Swanson, reproductive endocrinologist for McFarland Clinic in Ames, said research has shown the pill works in one of three ways.
It either delays the release of an egg from the ovary, alters the egg so it cannot accept a sperm, or it changes the lining of the uterus so if an egg is fertilized, it cannot implant itself into the uterine lining.
Swanson said many people confuse it with RU-486, the medical abortion pill, but EC does not affect women who are already pregnant.
“It doesn’t make a positive pregnancy negative,” Swanson said.
The possibility of preventing implantation of a fertilized egg, as well as confusion between EC and RU-486 have caused anti-abortion groups to write to the FDA by the thousands.
Jeffrey Beaird of Gadsden, Ala. wrote, “These so-called ‘Emergency Contraceptives’ and more specifically the drug’s brand-named Preven and Plan B are nothing short of controlled poisons which are marketed as a ‘solution’ to the ‘consequences’ of unprotected sexual intercourse.”
Students for Life President Ryan Babbitt said they oppose EC if it prevents implantation.
“Our view would be it is a very early, early term abortion,” Babbitt, senior in computer science, said.
“[In that case] we would be opposed because then it would be basically snuffing out a human life.”
Babbitt said he worries about EC being used over-the-counter because of research showing health risks.
“It’s my opinion that that’s why things are prescription anyway, so people don’t just go grab them and make some life decisions,” Babbitt said.
Swanson said that the risks involved with EC are minimal compared to the alternative.
“If the alternative [to EC] is pregnancy, the pregnancy is more risky,” Swanson said.
If the FDA does approve the pill for over-the-counter use, the problem of access to EC will be solved. Swanson said a number of women can’t get in to see their doctor in a 72-hour time span, and after that it’s too late.
Swanson said he doesn’t think it will end up on store shelves like aspirin but will be available from a pharmacy after a quick screening from a pharmacist.
“I don’t think anyone wants it to be totally over-the-counter,” Swanson said.
Melissa Grant, senior director of health services at Planned Parenthood, said it is only a matter of time before it is approved for over-the-counter use.
“Women are going to want something like this,” Grant said. “It’s a matter of time and we owe it to the American public.”
Grant said the idea that EC is a form of abortion has slowed the process.
“One of the things that has made this challenging, I would guess, in communities that don’t know a lot about it is this perception that it is an abortion, so some medical facilities won’t even offer it post-sexual assault,” Grant said.
Currently Washington, California, Alaska and New Mexico allow pharmacists to give EC without a prescription.
“[If the FDA approves it] it will be a victory for consumers,” Swanson said.