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

NEW YORK Wed May 8, 2013 7:27am EDT

A Plan B One-Step emergency contraceptive box is seen in New York, April 5, 2013. REUTERS/Shannon Stapleton

A Plan B One-Step emergency contraceptive box is seen in New York, April 5, 2013.

Credit: Reuters/Shannon Stapleton

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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)

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Comments (2)
yooper wrote:
The inappropriate intereference by politicians in women’s reproductive healthcare has lead to life expectancy for women falling in the rural areas of the former slave states. The imposition of political obstacles to contraception and abortion has resurrected black market providers of late-term abortions and abortifacients. A recent report released by the World Health Organization ranks the U.S. last amomg the developed world in neonatal survival rates. This is related to the high rate of unintended pregancy and the poor health of women of childbearing age.

May 08, 2013 8:16am EDT  --  Report as abuse
lizzi128 wrote:
This story left out the fact that the FDA initially approved sale without the age restriction and that TEVA was asked by the agency to resubmit its application with the age limit after consulting with the administration. The judge has every reason to be out of patience with the games played on this issue: the drug is proven safe for all ages, and the ID requirement places unnecessary obstacles in front of women and girls who seek to buy it. This looks like yet another attempt by the Obama administration to thread the needle on women’s right in order to placate various conservative critics of the ACA. It should be clear by now that those critics won’t be placated. And it should also be clear that women deserve more respect than we’re getting from a president who was elected and reelected with our overwhelming support.

May 08, 2013 12:11pm EDT  --  Report as abuse
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