Wednesday, July 29, 2015

Federal judge gives go-ahead to sale of over-the-counter, morning-after contraception for women of all ages

A New York federal judge on Friday refused to delay enforcement of his decision that women of any age should be able to buy over-the-counter, morning-after oral contraceptives.

Federal judge gives go-ahead to sale of over-the-counter, morning-after contraception for women of all ages


A New York federal judge on Friday gave the go-ahead for women of any age to buy over-the-counter, morning-after oral contraceptives. Plan B is made by Teva Pharmaceutical Industries Ltd., which is based in Israel but has its Americas headquarters in North Wales, Montgomery County. There are also generic versions.

The Associated Press story is below:

By Larry Neumeister

The Associated Press

NEW YORK — A judge on Friday refused to delay enforcement of his decision giving women of all ages broad access to morning-after birth control, calling the government's appeal frivolous, a "silly argument" and an insult to the intelligence of women.

U.S. District Judge Edward Korman in Brooklyn did agree to postpone implementation of his month-old decision until Monday to give the government time to appeal to the 2nd U.S. Circuit Court of Appeals in Manhattan.

"Indeed, in my view, the defendants' appeal is frivolous and is taken for the purpose of delay," Korman wrote. He called the government's reasoning "largely an insult to the intelligence of women."

Robert Nardoza, a spokesman for the U.S. attorney's office in Brooklyn, said the government was considering its options.

The government had warned that "substantial market confusion" could result if Korman's ruling was enforced while appeals are pending. The judge dismissed the reasoning as a "silly argument."

He blamed the government for any market uncertainty, saying it was responsible for appeals "taken solely to vindicate the improper conduct" of Health and Human Services Secretary Kathleen Sebelius, "and possibly for the purpose of further delaying greater access to emergency contraceptives for purely political reasons." The Food and Drug Administration was preparing in 2011 to allow over-the-counter sales of the morning-after pill with no agency limits when Sebelius overruled her own scientists in an unprecedented move.

The government announced its appeal last week after the judge on April 5 ordered levonorgestrel-based emergency contraceptives be made available without a prescription, over-the-counter and without point-of-sale or age restrictions. The order was supposed to take effect on Friday.

Korman said Friday that he ruled against the government "because the secretary's action was politically motivated, scientifically unjustified and contrary to agency precedent" and because there was no basis to deny the request to make the drugs widely available.

The judge said the principle that only the FDA has the necessary information and scientific expertise to access the data and information to determine whether a drug is safe was "flagrantly violated" by Sebelius. He said she had a "lack of competence in this area."

"Yet," he wrote, "in something out of an alternate reality, the defendants seek a stay to pursue an appeal that would vindicate the secretary's disregard of the very principle they advocate."

The FDA last week announced the contraception could be sold without a prescription to those 15 and older. Sales had previously been limited to those who were at least 17. Korman ridiculed the FDA changes, saying they established "nonsensical rules" that favored sales of the Plan B One-Step morning-after pill and were made "to sugarcoat" the government's appeal.

He also said they place a disproportionate burden on blacks and the poor by requiring a prescription for less expensive generic versions of the drug bought by those under age 17 and by requiring those over age 17 to show proof-of-age identification at a pharmacy.

In court papers, attorneys for the Center for Reproductive Rights have said every day that the ruling does not get enforced is "life-altering" to some women.

They said a delay for the duration of appeals "will perpetuate — for months, or years — the unconscionable delays that have permeated the defendants' actions with regard to emergency contraception."

After Korman's ruling Friday, Mara Verheyden-Hilliard, executive director of the Partnership for Civil Justice Fund, which represented plaintiffs including the National Women's Liberation, 15-year-old Anaya Kelly, the Center for Reproductive Rights and Southern Legal Counsel, said the administration of President Barack Obama "wants to placate the political right wing at the expense of the health needs and reproductive rights of women."

At a hearing earlier this week, Assistant U.S. Attorney Franklin Amanat defended the slow pace of the court case, saying: "Sometimes the people are better served when the government acts deliberately and incrementally."

In his Friday order, Korman said the "FDA is not the problem," placing the blame solely with Sebelius.

"She has not changed her position," he said. "A remand would thus be futile."

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David Sell blogs about the region's pharmaceutical industry. Follow him on Facebook.

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