Plan B drug ruling on hold


WASHINGTON - In a surprise move, the federal drug agency indefinitely delayed a decision on allowing sales of a "morning-after" pill without a prescription, saying yesterday that more study and public comment were needed.

Food and Drug Administration Commissioner Lester M. Crawford said that the Plan B drug could be sold safely to women 17 and older over the counter but that he needed to make sure that younger girls could not obtain the pill without showing a prescription.

The announcement outraged proponents of the drug, including Democratic Sens. Hillary Rodham Clinton of New York and Patty Murray of Washington state, who had blocked Crawford's confirmation as FDA chief until the Bush administration agreed to rule on the long-delayed Plan B application. In a letter last month, Health and Human Services Secretary Michael O. Leavitt promised Congress that the agency would act by Sept. 1.

The FDA normally approves sales after determining that a drug is safe and effective, so the indefinite delay prompted bitter back-and-forth over whether politics had trumped science.

"They're doing this because someone in the White House told them to do it," said Kirsten Moore, president of the Reproductive Health Technologies Project.

But Pia de Solenni of the Family Research Council said the agency moved correctly to probe unresolved scientific and moral issues.

"It looks like they're taking seriously some of the health concerns we have," she said.

A concentrated dose of the hormone used for birth control, Plan B is designed to prevent pregnancy if taken within 72 hours after sex. The pill either interferes with ovulation or prevents implantation of a fertilized egg.

The delay won't affect women in seven states whose governments have already granted some access to the pills without a prescription. Maryland is not one of those states.

But the delay prolongs a hotly contested process for nationwide approval that has played a part in the abortion fight. Some conservatives say the pill effectively causes an abortion, while liberals counter that it will reduce unwanted pregnancies and abortions.

Plan B has been available by prescription since 1999. Years of subsequent FDA study of potential sale without a doctor's orders have been marked by review and reconsideration and politicking.

The pill's maker, Barr Pharmaceuticals, first asked to sell Plan B over the counter in 2003. That year, an expert panel that advises the FDA recommended approval by a vote of 23 to 4.

But a senior agency official rejected the request last year, expressing concern about the drug's impact on the health of teen girls. So the manufacturer filed a new request, asking to sell the pill without a prescription to women 16 and older.

After the FDA missed a deadline for deciding, Clinton and Murray held up Crawford's confirmation until the agency agreed to take action by Sept 1.

The senators assailed the further postponement and called for a Senate hearing on the FDA's handling of the matter.

"FDA's only criteria for approval should be safety and efficacy, not politics and ideology," Clinton and Murray said in a statement.

In a news conference late yesterday afternoon, Crawford said data indicated that Plan B was safe for sale to women 17 and older without a doctor's orders.

But Crawford said the FDA would be making an "unprecedented" move if it distinguished how women could buy a drug with the same dosage, same packaging and same use on the basis of age.

Crawford said an additional complication was the FDA's ability to make sure girls 16 and younger would not get the pill without a prescription.

"Enforceability is ... the key unresolved question," he said. Crawford said 60 days of public comment was needed, followed by agency review of perhaps a sign-in system or other options for making sure pharmacies don't sell to young girls.

Bruce L. Downey, Barr's chairman and CEO, said he was "disappointed" by the announcement.

"While we believe that a delay is not justified, we will use the opportunity presented by the FDA proceedings to continue to press for approval," Downey said in a statement.

Supporters of the drug expressed concerns that the FDA was consigning the issue to a slow, bureaucratic death.

"That's like sending somebody to the gulag in Russia," said Cindy Pearson, executive director of the National Women's Health Network. "It's unfair to women, and it's wrong. The science supports approval."

But Wendy Wright of Concerned Women for America said Crawford was rightly taking into account public concerns that easy access to the drug would encourage more sex, leading to the spread of sexually transmitted diseases and endangering the health of girls.

"The FDA is recognizing it needs to look beyond the advisory committees and bureaucrats in the FDA. They may not accurately represent, for example, what parents would want," she said.

Supporters and opponents of Plan B had pressed the FDA and the White House as with few other drugs.

Both sides expect only more campaigning to follow.

The National Organization for Women called for a demonstration outside the Department of Health and Human Services on Tuesday. The Family Research Council will contact its grass-roots networks to encourage activists to contact the FDA.

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