April 22, 2009
The Associated Press is reporting today that the Obama Administration has decided to roll over for a federal district court decision issued last month commanding the Food and Drug Administration (FDA) to sell the morning-after-pill, Plan B, to 17-year-olds without a prescription.
Typically the Department of Justice (DoJ) would vigorously defend an agency decision - in this case FDA's restricting Plan B over-the-counter sales (OTC) to women 18 and over. Here, however, the Obama FDA and DoJ have decided to accept an aggressive court ruling without appeal. In essence, the Administration let a judge make a scientific decision as to when it was safe to sell Plan B over-the-counter.
In order for a drug to be sold OTC patients must be able to safely medicate themselves without medical supervision. FRC has always felt that the studies tracking the label comprehension for Plan B showed a poor awareness that Plan B was not a substitute for standard contraceptives. That would seem to be important for a contraceptive.
The Bush Administration officials were not convinced that the label comprehension data for teens demonstrated that they could use Plan B safely. The Bush officials thought more data needed to be submitted. Not exactly a crazy point of view.
Furthermore, the FDA-approved label for Plan B gives no clear indication that repeated use of Plan B in a short period of time is not safe. This feeds into the possibility that some women might repeatedly use Plan B rather than safer alternatives.
We noted last month that some minor girls will be able to obtain this drug without any guidance from a doctor or without any parental supervision. We lack scientific studies on the long-term effects of Plan B with respect to high dosage and repeated use in both women and adolescents. Also, research from Scotland in the 1990s indicated that the increased use of the morning-after-pill did not decrease abortion rates.
FRC has also pointed out that interaction with medical professionals is a major screening and defense mechanism for victims of sexual abuse. The availability of Plan B over-the-counter also bypasses the routine medical care of sexually active girls and women, which is important to allow screening for other health conditions, including sexually transmitted diseases. This is especially important for teenagers.