A Brooklyn, New York federal judge yesterday gave the US food and drug administration 30 days to begin allowing minors who don't have a prescription to buy Plan B, the morning-after pill that was the subject of intense political battles during the Bush administration.
Judge Edward Korman ruled that the FDA, which has restricted over-the-counter access to the emergency birth control drug to women 18 and older, must begin allowing 17-year-olds to buy it, and must also reconsider its ban on non-prescription sales to minors as young as 11.
In a blistering 52-page decision, Korman found that under the Bush administration, FDA restrictions on the drug had been influenced by conservative ideology and involved "political considerations, delays and implausible justifications," rather than being grounded in science and "reasoned decision-making."
"The record is clear that the FDA's course of conduct regarding Plan B departed in significant ways from the agency's normal procedures regarding similar applications to switch a drug product from prescription to non-prescription use," he wrote.
Plan B advocates had already been looking forward to a more favourable climate at the FDA under Barack Obama, who called for the separation of science and politics when he lifted Bush-era restrictions on stem-cell research a few weeks ago, and they lauded Korman's decision as an important advance.
"Today's ruling is a tremendous victory for all Americans who expect the government to safeguard public health," said Nancy Northup, head of the centre for reproductive rights, which brought the suit. "The message is clear - the FDA should put medical science first and leave politics at the lab door. We are encouraged that the agency, now under new leadership, will take that message to heart."
But the New York state catholic conference, which opposes all over-the-counter sales of Plan B, said making it easily available to younger women could open the door to its overuse as a primary method of birth control, with potential medical risks.
"It's a scary situation when a judge who is not a doctor can overrule the FDA on the proper age when someone can take a medication," said conference spokesman Dennis Poust. "It's completely inappropriate."
Because the drug needs to be taken quickly to be effective, proponents pushed for over-the-counter approval.
Despite studies and a scientific consensus that it could be safe and effective without a prescription, Korman found that over-the-counter approval for adults over 18 was delayed until 2006 amid evidence of "pressure emanating from the White House" and "departures from normal procedures".
He said there was no evidence at all that Plan B would be safer for 18-year-olds than 17-year-olds. For younger women, he said he thought it was better for the FDA - under new leadership - to make a medical decision than a federal judge.