Judge criticizes FDA move on Plan B, agency warns of precedent

By Jessica Dye and Toni Clarke

NEW YORK (Reuters) - A federal judge criticized the Food and Drug Administration over its refusal to make emergency contraception available to girls of all ages without a prescription, saying the agency's move to restrict distribution to consumers aged 15 and older was not realistic.

District Judge Edward Korman on April 5 ordered the FDA to lift age restrictions on all levonorgestrel-based emergency contraception - also known as the "morning-after" pill or "Plan B" - to prevent unwanted pregnancies.

At a hearing in Brooklyn, New York, on Tuesday, he said he would rule by the end of the week on the FDA's request to stay the order, which is slated to take effect May 10. The FDA has appealed the ruling to the 2nd U.S. Circuit Court of Appeals in Manhattan.

"I do think there is a principle that is a dangerous one of a court ordering the FDA to approve a drug," FDA Commissioner Margaret Hamburg told the Reuters Health Summit in New York on Monday ahead of the hearing. "You have to step back and look at this not just in terms of Plan B but in terms of the precedent."

Late last month, the FDA said it would allow girls as young as 15 years old to buy Plan B One-Step contraception, made by a unit of Teva Pharmaceutical Industries Ltd, without a prescription. Cashiers will still have to verify the customer's age before selling it. The agency said the move was based on data provided by Teva that showed girls of that age could safely use the drug without the intervention of a healthcare provider.

Korman called the decision "a lot of nonsense," saying that 15- and 16-year-olds may not have photo identification needed to buy the drug.

The judge noted that the FDA's restrictions still apply to other forms of emergency contraception, including a two-pill version of Plan B and its generic equivalents. These are only available to women 17 and older with identification.

Korman also questioned the timing of the decision, made one day before the FDA filed its notice of appeal of the April order.

"I'm convinced the only reason you decided it when it was decided was to sugarcoat this appeal," Korman told a lawyer for the FDA, Farzin Franklin Amanat.

A lawyer for the plaintiffs, Janet Crepps of the Center for Reproductive Rights, countered that the different access rules for Plan B One-Step and other forms of emergency contraception had created a "convoluted" system for girls and women seeking the drug in its brand name and generic forms.

"That's what happens when you let politicians instead of scientists make these decisions," Korman replied.

Emergency contraceptives generally sell for $10 to $80. Although they can work as long as 120 hours after unprotected sex, they are most effective in the first 24 hours.

Asked about the ongoing court case, Teva Chief Executive Jeremy Levin said the company provides medicines where they are needed.

"I'm not interested in getting into politics," he told the Reuters Health Summit. "The bottom line is that we believe we are providing an important medicine."

(Reporting by Toni Clarke in New York; Editing by Michele Gershberg and Prudence Crowther)

Source: http://news.yahoo.com/judge-criticizes-fda-move-plan-b-agency-warns-112700529.html

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