Plan B is one of two emergency contraceptives available in the U.S.
The judge's order effectively overturns a controversial 2011 decision by Secretary of Health and Human Services Kathleen Sebelius overruling the Food and Drug Administration. After years of study and internal debate, the FDA had decided that Plan B One Step should be allowed for sale without a prescription — and without age restrictions.
In the ruling dated April 4, Senior Judge Edward R. Korman of the Eastern District of New York held that Sebelius's decision on Plan B was "arbitrary, capricious, and unreasonable."
On page 47 of the 59-page decision, Korman skewers Sebelius's decision, calling it "politically motivated, scientifically unjustified, and contrary to agency precedent ...."
He also slammed the FDA's rejection of a so-called Citizen's Petition dating to 2005 that argued for the agency to approve unfettered over-the-counter sale of Plan B. That rejection, he said, was a direct consequence of Sebelius's ruling.
In the decision, Korman sends the Plan B case back to FDA with orders to make the morning-after pill "available without a prescription and without point-of-sale or age restrictions within 30 days." If the agency decides the instructions for the drugs need tweaks, that's OK.
When Sebelius essentially vetoed the FDA's decision in late 2011, women's health groups erupted in protest. "As doctors and researchers have repeatedly stated, ample research shows Plan B to be safe for women of all ages and appropriate for over-the-counter access. It is deeply disappointing that this administration would repeat the mistakes of the previous one," said Susan Wood, an associate professor at George Washington University's School of Public Health. Wood was an assistant commissioner for women's health at the FDA but quit in 2005 over its continued delay on over-the-counter approval for Plan B.
Advocates for Plan B kept up the pressure on the administration to reverse itself. They argued, in part, that the rules were just too complicated. "The unique dual-labeling of Plan B One Step has led to confusion among consumers and health care professionals alike, particularly regarding age restrictions and whether men and women can purchase non-prescription emergency contraception," said a letter signed by more than three dozen women's health, reproductive rights and individual providers of health care.
"A recent Boston University study of 943 pharmacies in five major cities revealed that, when called posed as 17 year olds seeking EC, one in five were told they could not purchase EC under any circumstances," the letter said at the time. In fact, those 17 and older are eligible to purchase the product without a prescription; those 16 and younger may purchase it with a health provider's written order.