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Judge again rejects limits on emergency contraception

Drugs such as Plan B should be available over the counter to all ages, says the ruling, which also criticizes Health and Human Services Secretary Kathleen Sebelius.

May 11, 2013|By Monte Morin, Los Angeles Times
  • A federal judge has refused the Justice Department's request to issue a stay on his ruling requiring emergency contraception to be sold over the counter to customers of all ages. Pharmacist Simon Gorelikov holds a generic version of the pill.
A federal judge has refused the Justice Department's request to issue… (AP Photo/Elise Amendola )

In yet another scathing critique of government health officials, a federal judge refused Friday to stay his order making emergency contraceptives available to consumers of all ages without a prescription.

Calling government efforts to restrict the sale of drugs such as Plan B "frivolous and taken for the purpose of delay," U.S. District Judge Edward R. Korman of New York wrote that the medications would be available to all unless the 2nd Circuit Court of Appeals ruled otherwise by noon Eastern time on Monday.

The action was 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 to minors.

In a 17-page ruling, Korman said the actions of 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 lacked "any medical or scientific expertise" and that she undermined the nation's drug approval process when she overruled a decision by the Food and Drug Administration to allow the drug to be sold to everyone without a prescription.

"The FDA is not the problem," Korman wrote. "The cause of the rejection of over-the-counter sale of … emergency contraceptives was the secretary of Health and Human Services."

The Justice Department, which has argued the government's case, declined to comment Friday on Korman's ruling.

Nancy Northup, president of the Center for Reproductive Rights, the New York-based advocacy group that is 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 statement.

Plan B and the related Plan B One-Step are manufactured by the Israel-based company Teva Pharmaceutical Industries Ltd. Generic versions of the drugs are also available.

The pills use the synthetic hormone levonorgestrel to prevent pregnancy by blocking ovulation and impeding the mobility of sperm. The drugs do not cause abortion in women who are already pregnant, nor do they harm a developing fetus.

They are most effective when taken immediately after unprotected intercourse, and reproductive rights groups have complained that restrictions on their purchase cause unnecessary delays and 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 implementing that order, however, the FDA came out with new guidelines lowering the minimum age to purchase Plan B One-Step from 17 to 15 years old. People 15 and older can buy the drug without a prescription, but 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 request for a stay. Government lawyers argued that it would be a violation of the separation of powers if a judge were able to dictate to the FDA how drugs are sold.

In his ruling 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."

It was Sebelius, he wrote, who was "undermining the public's confidence in the drug approval process."

monte.morin@latimes.com

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