This is a story about political wars waged, of battles lost and won. It is a story about the domination of ideology over science, and the art of illusion. It is a story about a pill.
One week ago today, the U.S. Food and Drug Administration moved to allow Plan B to be available over the counter. The drug is a high-dosage contraceptive that, taken within 72 hours of unprotected intercourse, prevents a pregnancy from occurring.
It will be available only in pharmacies or health clinics, only to women with proof of age and not until the end of the year, when Barr Pharmaceuticals Inc. updates the pill’s labeling. Females under the age of 18 will still need a doctor’s prescription to purchase the drug.
It has been estimated that the approval of emergency contraceptives to over-the-counter status would prevent 1.5 million unintended pregnancies and more than 800,000 abortions a year, according to the Guttmacher Institute, a nonprofit organization focused on sexual and reproductive health research.
Despite these benefits, the decision came after more than three years of rising climax complete with antagonistic forces, political manipulation and bureaucratic limbo.
It was finally approved only after Sens. Patty Murray, D-Wash., and Hillary Clinton, D-N.Y., said they would block the confirmation vote for Andrew von Eshcenbach, Bush’s nominee to head the FDA, until a decision was made.
Why did it take more than three years of debate and an unprecedented political power move to secure FDA approval? Well, this wouldn’t be a very good story without conflict, now would it?
And conflict there is. Some anti-abortion groups have denounced Plan B as an abortion pill. They obviously didn’t read the label.
Though Plan B has been somehow mistaken for an abortifacient, it is actually just an upped dose of levonorgestrel, the same hormone in many birth control pills. In fact, as early as 1976, research showed that taking multiple birth control pills at once could be used for pregnancy prevention after sex.
EC is actually safer than most cold medicine that can be obtained over the counter, according to Joseph Feldman, the abortion program manager for Planned Parenthood of Central and Northern Arizona.
The fact that EC is more tightly regulated than cold medicine is inconsistent with other over-the-counter policies – especially considering that the danger of turning EC into a methamphetamine, such as can be done with some cold medicines, is stuff only fairytales are made of.
Even the FDA believes Plan B is safe for all ages. The agency’s drug chief, Dr. Steven Galson, acknowledged overruling FDA staff scientists’ 2004 opinion that nonprescription sales would be safe for all ages.
The truth is that it is not harmful at all – regardless of age.
Many additionally argue that the availability of the “”morning-after”” pill to minors without a prescription condones teenage promiscuity.
Yet the New England Journal of Medicine reported that evidence shows that the availability of EC does not result in a change in behavior or contraceptive practices of the women who would potentially use it.
Unfortunately, sound scientific research conducted both in-house and by private organizations, the projected benefits of the drug and consumer necessity just weren’t enough for the FDA. Instead, it took a political threat to the approval process of the FDA’s own chief before it would move ahead with the approval process of Plan B.
The moral of the story? It appears that for our administration, drug regulation is more about politics than advancing public health, and health policy is more influenced by ideology than by science.
EC’s over-the-counter approval ends one lengthy chapter. But, with the age-restrictions that hinder the policy, this story is far from over.
Courtney Smith is a senior majoring in molecular and cellular biology and anthropology. She can be reached at letters@wildcat.arizona.edu
