WASHINGTON (August 24, 2006) — The Food and Drug Administration (FDA) announced today (August 24) that it has approved Barr Pharmaceutical's "Plan B" for distribution without a prescription to women age 18 and over.
Deirdre McQuade, Director of Planning and Information for the Secretariat for Pro-Life Activities at the United States Conference of Catholic Bishops, objected to the approval in the following statement:
"We find the FDA's unprecedented decision to make Plan B available without a prescription completely unacceptable. Women deserve quality health care, but over-the-counter (OTC) use of this potentially abortifacient drug will compromise informed consent and follow-up care when necessary.
"The FDA describes Plan B as 'a contraceptive drug' and equates its side effects to those of ordinary birth control pills. While Plan B can prevent fertilization, the manufacturer admits it may also prevent a newly-conceived embryo from implanting and surviving in the womb. This is properly understood as causing an early abortion.
"Without the benefit of a doctor's supervision, many women will be unaware of this abortifacient action and the other risks posed by Plan B.
"Plan B is a powerful dose of the artificial hormone, Levonorgestrel – 40 times the amount found in comparable prescription-only birth control pills. Making the more potent dosage available to women upon request simply offends common sense – especially when the drug is not designed to treat a disease or pathological condition.
"According to Plan B's new packaging insert, the risk of potentially fatal ectopic pregnancy is up to five times higher with progestin-only birth control. But if women take the drug quickly, as advised, they may not take the time to read all the fine print and could put themselves at unnecessary risk.
"Despite exaggerated claims to the contrary, Plan B will not realistically reduce abortion rates. Research in Europe and the U.S. has shown that increased access to 'emergency contraception' has a negligible effect on the rate of unplanned pregnancies and abortions.
"The burden now shifts to pharmacies to do the right thing for women's health. I urge health care providers not to confuse FDA approval with a right to access and refuse to stock this potent drug for distribution on demand."
For USCCB comments to the FDA and other information on the morning-after pill, go to: www.usccb.org/prolife/issues/contraception/morningafterpill.htm.