Judge blasts government’s Plan B contraceptive filing
In yet another scathing critique of government health officials, a federal judge refused Friday to stay his order making Plan B emergency contraceptives available to all consumers without a prescription.
Ruling that government efforts to restrict the drug’s sale were “frivolous and taken for the purpose of delay,†U.S. District Judge Edward R. Korman of New York wrote that the drug would be available to all unless the 2nd Circuit Court of Appeals ruled otherwise by noon on Monday.
The action was just the latest in a long battle between reproductive rights advocates and two White House administrations that have sought to restrict the sale of so-called morning after pills.
In a 17-page ruling, Korman said the actions of U.S. Health and Human Services Secretary Kathleen Sebelius were in “bad-faith†and “politically motivated,†and that government lawyers were functioning in “an alternate reality†when they requested the stay.
Korman wrote that Sebelius “lacks any medical or scientific expertise†and undermined the nation’s drug approval process when she overruled a decision by the FDA to make the drug available to all ages without a prescription.
“The FDA is not the problem,†Korman wrote. “The cause of the rejection of over-the-counter sale of levonorgestrel-based emergency contraceptives was the Secretary of Health and Human Services.â€
The U.S. Department of Justice, which has argued the government’s case, declined to comment on Korman’s ruling Friday.
Nancy Northup, president of the Center for Reproductive Rights, the plaintiff in the case, welcomed the order.
“Judge Korman’s sound ruling simply orders the government to do what the experts at FDA have been trying to do for years: to put politics aside and let science guide us to a policy that makes emergency contraception readily accessible to all women when they need it most urgently,†she said in a prepared statement.
Plan B and the related, Plan B One-Step, are manufactured by the Israel-based company Teva Pharmaceutical Industries Ltd. The drugs use the synthetic hormone levonorgestrel to prevent pregnancy by blocking ovulation and impeding the mobility of sperm.
The drugs do not cause an abortion in women who are already pregnant, nor does it harm a developing fetus. They are however, most effective when taken immediately after unprotected intercourse, and reproductive rights groups have complained that government purchasing restrictions cause unnecessary delays or prevent access to the drugs.
Acknowledging those concerns, Korman issued an order on April 5 stating that the drugs must be sold over-the-counter, without age restrictions, within 30 days.
Instead of acting on that order however, the FDA came out with new guidelines lowering the minimum purchasing age from 17 to 15 years old. Although people 15 and older can buy the drug without a prescription, they must show an ID.
Not long after that FDA action, the Department of Justice filed an appeal of Korman’s order, as well as a stay. Government lawyers argued that it would be a violation of the separation of powers if a judge dictated the sale of drugs and not the FDA.
In his ruling on Friday, Korman said that argument “ignores the fact that the FDA found that the drug was safe and could be used properly without a doctor’s prescription.â€
It was Sebelius, he wrote, who was “undermining the public’s confidence in the drug approval process.â€
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