The Obama administration filed an appeal notice Wednesday to
challenge a judge’s decision requiring that the morning-after pill be
available without a prescription to girls of any age.The Department of Justice is contesting the decision of U.S. District Judge Edward R. Korman on the grounds that “the remedies that the judge ordered were beyond his authority,” according to a Justice Department official who spoke to the New York Times anonymously.
The judge had ruled in April that the FDA must make the morning-after pill, Plan B One Step, available over-the-counter with no age restrictions.
While the FDA had initially recommended this policy change, it was overruled by Kathleen Sebelius, secretary of the Department of Health and Human Services, in December 2011.
Sebelius argued that there was not enough information to prove that the drug would be safe for use by younger girls and noted “significant cognitive and behavioral differences” between older adolescent girls and those that are in their pre-teen or early teen years.
The judge challenged Sebelius’ decision, saying that it was too political. He ordered the FDA to change its policy and remove all age limitations on the morning-after pill.
The drug levonorgestrel, the active ingredient in Plan B and its generic versions, is called the “morning-after-pill” because of its ability to prevent pregnancy by stopping ovulation following a sexual encounter.
However, the drug’s label warns that if ovulation has already occurred, Plan B can also prevent implantation in the mother’s womb, thereby ending the life of the already-created human embryo.
The appeal by the Obama administration will not state a suggested age limit for access to the morning-after pill, but will instead simply argue that the judge did not have the authority to place the specific policy demand on the FDA.
“The public interest will not be served by reclassification of drugs as non-prescription by order of a court, without appropriate agency decision-making procedures being followed,” wrote U.S. Attorney Loretta Lynch in a letter to the judge.
The appeal announcement will not affect the new rule unveiled by the FDA the previous day to lower the age of over-the-counter access to Plan B from 17 to 15 year of age. The decision is independent of the judge’s orders and does not fully comply with them because it does not entirely remove all age restrictions.
Critics have warned that the decision to lower the age of access will recklessly allow young teenage girls to obtain a powerful and potentially dangerous drug being provided without parental permission or notification. They have noted that the morning-after pill has been associated with cancer, blood clots, heart attacks and stroke, as well as higher risks of ectopic pregnancy.
In addition, concerns have been raised over the lack of studies about the drug’s effects on girls during puberty, as well as its potential to be used to cover up sexual abuse and to cause early abortions.
Some opponents of the new rule warned that it may encourage risky behavior, as many teens may not be mature enough to understand that the morning-pill should not used routinely as a contraceptive and does not protect against sexually transmitted infections.
Abortion advocacy groups including NARAL Pro-Choice and the Center for Reproductive Rights also criticized the new policy, saying that it did not go far enough.
These groups have pushed for all restrictions on the drug to be lifted, allowing children of any age to purchase it over-the-counter without parental notification or consent.