HHS-FDA Plan B decision gets hearing in Brooklyn court

A federal judge in Brooklyn is scheduled to hold a hearing Tuesday in case regarding Teva Pharmaceuticals' request for a change in status of its Plan B morning-after contraceptive.

The decade-long debate about the pill did not end with last week's controversial decision by Health and Human Services Secretary Kathleen Sebelius to overrule the U.S. Food and Drug Administration and maintain the restrictions, which require a prescription for those 16 and under while those 17 and older can get it without a script by asking at the pharmacy counter.

Teva would like the product to be available over the counter and on an aisle shelf.

Teva is not alone in this matter. Several health groups have advocated for the change, arguing that science should not be trumped by politics or parental concerns.

As the Associated Press reported, 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. 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.

Meanwhile, Sebelius reportedly said that her decision was not political and that Teva could re-apply with better data that shows younger girls age 10 or 11 could understand the important choices that birth control involves. The Bloomberg story is here.