The next stage of the Plan B saga moves to the courts. Even before last week’s controversial decision keeping the morning-after pill behind the pharmacist’s counter, and requiring women under 17 to secure a prescription before purchase, a coalition led by the Center for Reproductive Rights planned to take the government to court over age restrictions for the drug. Today, that hearing takes place.
The Center for Reproductive Rights and other groups have argued that contraceptives are being held to a different and non-scientific standard than other drugs and that politics has played a role in decision making. Social conservatives have said the pill is tantamount to abortion.
Judge Edward Korman was highly critical of the government’s handling of the issue when he ordered the FDA two years ago to let 17-year-olds obtain the medication. At the time, he accused the government of letting “political considerations, delays and implausible justifications for decision-making” cloud the approval process.
In court papers prior to Wednesday’s hearing, Assistant U.S. Attorney Scott Landau said the government had complied with Korman’s orders by lowering the cutoff for over-the-counter sales of the drug from 18 to 17.
He said the plaintiffs “unfairly accuse FDA of bad faith and delay.”
The fact that this is the same judge who altered FDA guidelines on Plan B previously should give some hope that he will respond favorably to this request. The result of the order could eliminate the need for a prescription for Plan B among teenage girls, although I’m not sure whether the judge could force the drug onto the counter.
Health and Human Services Secretary Kathleen Sebelius defended her actions to restrict Plan B, claiming that her objections were scientific and not political, due to a “large missing piece of the puzzle” in the data. This suggests the issue could be taken up again, but of course the idea that the data was inconclusive is highly suspect: FDA researchers worked for years to determine the safety of Plan B for unrestricted use, on top of what the manufacturer of Plan B, Teva, provided.
And I suspect all of that data will be made available to Judge Korman today at trial. So it’s at least possible that, within a number of months, the restrictions will be lifted. Perhaps that was part of the calculus at the White House, that they could get the courts to institute this over their objections, so they didn’t have to take the heat for it. Of course, the restrictions were bad politics quite on their own, so that strategy makes little sense as well.