News Release: FDA Decision on Plan B is Bad Medicine for Women

The FDA’s recent decision to allow over-the-counter status for Plan B “emergency contraception” for women age 18 and over may be superficially appealing, but it is a step backward in women’s reproductive healthcare.

Despite assurances that this decision will lead to a reduction in unintended pregnancies and abortions in the United States, actual data demonstrate that even providing women free “emergency contraception” on hand at home has not made a difference in the unintended pregnancy or abortion rates of women. Going to a pharmacy to buy this medication is certainly less convenient than in study conditions. Therefore, it can reasonably be assumed that the results will be the same: no decrease in unintended pregnancy or abortion rates.

Indeed, the United Kingdom has had over-the-counter access for “emergency contraception” since 2001 and UK abortion rates have risen to their highest levels ever. On the other hand, the potential risks to women’s health are considerable.

Many women will bypass the sexually transmitted disease testing they would normally receive at the physician’s office. These infections, such as Chlamydia, HIV, Human Papilloma Virus and others will go undiagnosed and untreated, leading to infertility, chronic pelvic pain, or even cancer.

Women using Plan B who do conceive have at least 3 times the risk of potentially fatal ectopic pregnancy. They will be taking the drug without physician follow-up. How will they know when their life may be in jeopardy from a tubal pregnancy without physician involvement? They won’t as bleeding and abdominal pain are symptoms of both a normal menstrual period and of a rupturing ectopic pregnancy.

Safety data of this medication in the pediatric and young teenage population is scarce, yet women younger than age 18 will surely obtain this drug from those over age 18, as there is no mechanism to monitor or control such activity. Male sexual predators can easily use this medication to cover their abusive and unlawful actions. Likewise, the potential exists for increased pressure on young women to become sexually active, since they may be led to believe that preventing pregnancy is as simple as taking a pill after intercourse. For many, such sexual exploitation will not be in their best health interest.

The FDA labeling states that the medication will not abort an implanted pregnancy, but allows that it may stop implantation of a fertilized egg (an embryo). We object to this deceptive doublespeak. Terminating a human embryo is abortion, whether before or after its implantation into the uterus. Adequate informed consent dictates that the woman using this medication be plainly informed of this abortifacient potential.

Although short-term studies suggest that the ready availability of “emergency contraception” does not alter women’s use of standard contraception, it is possible that increasing familiarity with this medication over time may lead to more reliance on it by some women for their general contraceptive needs. Thus, independent of physician monitoring, this medication may be used repeatedly and frequently by many women. There are no studies addressing long term health effects of this type of use.

In light of these concerns, the FDA decision granting over-the-counter status for Plan B falls short of common sense, sound medical judgment, and good public health policy.