U.S. court enters fray over morning-after pill
WASHINGTON — A US federal judge heard arguments Tuesday about the government’s decision to deny over-the-counter access of emergency contraception to girls under 17, as part of a decade-long legal battle.
Federal Judge Edward Korman heard from the Food and Drug Administration and the Center for Reproductive Rights one week after the US government blocked access without a prescription to younger teens.
A ruling was not immediately expected, a spokeswoman for the Center for Reproductive Rights told AFP.
Women’s health groups have been urging the FDA to make emergency contraception more widely available to girls for the past 10 years by filing a citizen’s petition with the FDA asking the regulator to remove prescription requirements.
Women’s advocates argue that US regulators have placed politics above science by restricting access to the morning-after pill which can prevent pregnancy if taken within 72 hours of unprotected sex.
Korman in 2009 sided with the Center for Reproductive Rights and ordered the FDA to address its petition seeking wider access.
Last week, the FDA was poised to allow a drug known as Plan-B One Step to be available on drugstore shelves to girls age 12-17 without a prescription, but was overruled at the last minute by Health and Human Services (HHS) Secretary Kathleen Sebelius.
President Barack Obama later defended Sebelius’ move, essentially siding with conservative family groups on the issue and angering many among his liberal base.
“As the father of two daughters, I think it is important for us to make sure that we apply some common sense to various rules when it comes to over-the-counter medicine,” Obama said on Thursday.
Tuesday’s hearing relates to a separate matter, in which the Center for Reproductive Rights accuses the FDA of ignoring its citizen petition for wider access, filed in 2001 on behalf of 60 health groups.
Late Monday, the FDA issued a response, saying that it needs “additional data to support a switch of Plan B (to over-the-counter) for women younger than 17 years of age.”
The regulatory agency reasoned that there has been no new data showing that young teens can effectively follow the two-step regimen of Plan B, which requires two doses 12 hours apart and which was the subject of the original petition.
The product that the FDA was poised to approve over the counter access for — before HHS blocked it — was Plan B One-Step, which is made by Teva Pharmaceuticals and contains a double dose of Plan B to be taken in a single pill.
Nancy Northup, president of the Center for Reproductive Rights, a group that says it uses the law to advance reproductive freedom as a fundamental human right, blasted the FDA move.
“On the eve of a contempt hearing, the FDA has once again come up with an excuse to treat the approval of contraceptives differently from any other drug,” she said in a statement.
“It is truly stunning the lengths to which the agency will go to deny women access to emergency contraceptives that have been proven safe and effective for years.”
Plan B One-Step has been available at pharmacy counters without a prescription to women age 17 and older since 2009, but younger girls must see a doctor first to obtain a prescription.
In a sign of increasing political discontent over the matter, 14 US senators on Tuesday sent a letter to Sebelius demanding that she “provide the scientific basis behind her decision.”
“We ask that you share with us your specific rationale and the scientific data you relied on for the decision to overrule the FDA recommendation,” said the letter, signed by 13 Democrats and one independent.
“On behalf of the millions of women we represent, we want to be assured that this and future decisions affecting women’s health will be based on medical and scientific evidence.”