FDA told to reconsider morning-after pill

WASHINGTON/NEW YORK (Reuters) - The U.S. Food and Drug Administration must reconsider its decision under the Bush Administration to limit access to emergency contraception, a U.S. court ruled on Monday, saying the agency allowed politics to interfere with its usual decision-making.

Pills line the shelves of a pharmacy in Los Angeles April 16, 2007. REUTERS/Lucy Nicholson

The U.S. District Court for the Eastern District of New York, in a 52-page ruling, also ordered the FDA to allow 17-year-olds to buy the drug, called Plan B, without a prescription.

“The FDA repeatedly and unreasonably delayed issuing a decision on Plan B for suspect reasons,” the court said.

The agency deviated from its own standard procedures for reviewing over-the-counter products, the court said. It said the agency only made a plan B decision because of threats to hold up Senate confirmation of Dr. Andrew von Eschenbach to become FDA commissioner.

FDA officials in 2006 allowed easier, “behind-the-counter” sales to those age 18 and older who show proof of age while still requiring a prescription for women 17 and younger.

Its maker, Barr Pharmaceuticals, had originally sought over-the-counter access without any age requirements. Barr was recently acquired by Teva Pharmaceutical Industries Ltd.

“While we did not file the Citizens’ Petition, the company believes that timely access to Plan B is extremely important, as the sooner Plan B is taken the more effective it is. We will work closely with the FDA to ensure that all provisions of this decision are met,” said Teva spokeswoman Denise Bradley.

Company officials and advocates have said it is critical to give young women easy access to the so-called morning-after pill, which works best to prevent unwanted pregnancies when used within 24 hours of sexual intercourse. It contains higher doses of progestin than are used in prescription birth control pills.

“The court recognized that the FDA favored politics over science, ideology over women’s health, and violated the law in the process,” said Nancy Northup, president of Center for Reproductive Rights, which filed suit against the FDA in 2005.


“Emergency contraception is proven safe and effective, and today we have succeeded in expanding access to 17-year-olds and are one step closer to making it fully available to all women,” she said.

The court gave the FDA 30 days to allow nonprescription use for 17-year-olds. FDA spokeswoman Rita Chappelle said the FDA had received the court’s opinion, and was “reviewing it now.”

Dr. Susan Wood, the former head of the FDA’s Office of Women’s Health who resigned in protest over the its handling of Plan B, said she was delighted.

President Barack Obama has pledged to restore reliance on science in making decision on health, climate and energy. He has tapped former New York City health chief Dr. Margaret Hamburg to be FDA commissioner and Baltimore’s health commissioner, Dr. Joshua Sharfstein, as her deputy.

“The incoming leadership of FDA ... are committed to making sure that FDA gets back on track. I think that leadership will really make sure that the agency is making its decisions that are based on science,” Wood, now a research professor at George Washington University, told reporters.

Women’s health advocates hailed Monday’s ruling, which comes days after a U.S. report found the birth rate for teenage girls rose for the second straight year in 2007.

“If we can help teens who want to postpone childbearing to do that with safe and effective products, we’re very happy to see those products be made available,” said Amy Allina, program and policy director at the National Women’s Health Network.

Some advocates still want true over-the-counter access so that Plan B can be bought any time without showing identification to a pharmacist.

Additional reporting by Maggie Fox in Washington; editing by Gerald E. McCormick and Matthew Lewis