Former FDA official talks EC
When the Food and Drug Administration approved in August the emergency contraceptive Plan B as an over-the-counter drug for women aged 18 and older, many celebrated in the name of women’s reproductive rights.
Others, like former FDA assistant commissioner for women’s health, Susan Wood, were not so festive.
When the Food and Drug Administration approved in August the emergency contraceptive Plan B as an over-the-counter drug for women aged 18 and older, many celebrated in the name of women’s reproductive rights.
Others, like former FDA assistant commissioner for women’s health, Susan Wood, were not so festive.
According to Wood, who spoke Thursday in the University Student Commons, the August decision was not only almost three years overdue; it went against well-known scientific evidence – prepared by FDA officials, no less – that ensured emergency contraception is safe for females of all ages.
Wood said she became so frustrated by the wrangling over Plan B within the FDA she resigned in August 2005. She said her reason was clear: too much controversy had surrounded the drug when none belonged in the first place.
“It’s misinformation and confusion that has made something that’s really not controversial once you have the facts into something much more controversial,” Wood said.
The bottom line, she said, is that emergency contraception is just a higher dose of the hormones in birth control, the main difference being that emergency contraception is supposed to be taken immediately after sex to prevent an unintended pregnancy. Emergency contraception is said to be 89 percent effective if it is taken within 72 hours of sex, after which it increasingly loses its strength.
“If you’re comfortable with the birth control pill, you can be perfectly comfortable with emergency contraception,” Wood said.
Wood stressed the comparison between emergency contraceptive pills and birth control pills because she said mainstream society has little problem with the latter. But opponents have mostly confused the public about emergency contraception, she said, by claiming it is a form of chemical abortion or an advertisement for sexual promiscuity.
She said it has not helped public perception that the FDA took years to label Plan B after its manufacturer, Barr Pharmaceuticals Inc., first submitted an application for over-the-counter status in 2003. Although various reviewers and office directors recommended approving Plan B for all ages, the FDA did not approve it.
When Barr Pharmaceuticals resubmitted Plan B in 2004, this time with an age restriction for women aged 17 and older, the FDA did not respond. Until the agency approved the drug in August for women aged 18 and older, it remained prescription-only.
– Susan Wood
Former assistant commissioner for women’s health, Food and Drug Administration
Wood said the initial reason for not approving over-the-counter status was that not enough young women had been included in studies about Plan B, and it was unclear if and how well they would understand its directions.
Wood said these were legitimate concerns, but the FDA “has never asked that question of any other drug at any other time.”
She added, “We don’t ask it about the cold medicine or pain medicine or medicine for yeast infections.”
Several audience members asked Wood questions about the role politics has played in Plan B’s arrival in the marketplace. She responded that she does not know why the FDA has acted as it has, but she believes outside pressures influenced the decision making of former FDA Commissioner Lester Crawford.
Wood said the overall effect is that bureaucracy and politics have shifted the FDA’s focus to a single form of contraception when it should be looking at issues related to women’s health in a comprehensive fashion.
Laurel Murray, president of Voices for Planned Parenthood or VOX at VCU, which sponsored Wood’s lecture with the Honors College, said politics will continue to play a role in emergency contraception’s availability.
That is why VOX will participate in Pro-Choice Lobby Day, which will take place Jan. 25 outside the General Assembly. Residents from across the state are expected to show up at the rally to voice support for women’s access to abortion and contraception.
The basics
What is emergency contraception?
It is a safe, effective backup form of birth control that can be taken after unprotected sex, contraceptive failure or sexual assault.
How does it work?
Evidence shows it prevents ovulation, the release of a mature egg from the ovaries. It is unclear whether emergency contraception can prevent fertilization.
What are its side effects?
The most common side effects include nausea and vomiting. Other less common side effects include headache and fatigue.
Source: advocatesforyouth.org
Now that Plan B has over-the-counter status, Murray expects it to arise as an issue in the state legislature.
“Because it has been granted over-the-counter status, we are expecting backlash, and severe restrictions are going to be attempted to be imposed on its availability,” she said.
Laura Elkovich, a VOX member and junior biomedical engineering major, said legislation and regulation of contraception expose problems in education.
“If schools did more about comprehensive sex education, we wouldn’t need to put as many regulations on things because kids would have the education to actually make decisions themselves,” she said.
Andreya Susaeta, also a VOX member and a junior psychology major, agrees with Wood’s criticisms of Plan B’s age restriction. She said it gives emergency contraception a degree of taboo like cigarette smoking.
“I just think the age restriction is silly because there is no age restriction on when you can have sex. It’s just unnecessary, and at the same time, it’s difficult,” she said. “You can’t regulate people’s private lives. That’s just what it goes down to.”
