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Saturday, August 27, 2005

Morning-After Pill: Politics and the F.D.A. - New York Times

Morning-After Pill: Politics and the F.D.A. - New York TimesAugust 28, 2005
Morning-After Pill: Politics and the F.D.A.
By GARDINER HARRIS

WASHINGTON, Aug. 27 - For more than a year, federal drug officials have insisted that their repeated delays in deciding whether to approve over-the-counter sales of a morning-after contraceptive have nothing to do with abortion politics.

Among veterans of the battles over drug approvals here, it is hard to find anyone who believes them.

On Friday, the food and drug commissioner, Lester M. Crawford, announced that he would indefinitely postpone a ruling on Plan B, the morning-after pill made by Barr Laboratories. He explained that while the science supported over-the-counter access for women 17 and older, the agency had not figured out how to do that without younger teenagers getting the pills.

While the announcement prompted familiar responses on each side of the abortion debate - protest from abortion rights groups, support from abortion opponents - other veterans of the drug wars sounded more exasperated than anything else.

"At some point, the statute requires that the agency make a decision," said Dr. Eve E. Slater, an assistant secretary of health from 2001 to 2003. "You can't just delay forever."

The Plan B decision has become "overly politicized, and it shouldn't be," Dr. Slater added. Under federal regulations, the Food and Drug Administration was required to reach a decision on Plan B by January. Nothing happened. Indeed, Barr executives said they had no discussions with the agency after January. Usually when the agency is actively considering an application, there is a constant back-and-forth with the company.

As the months passed, two Democratic senators who support abortion rights, Hillary Rodham Clinton of New York and Patty Murray of Washington, vowed to block any vote on President Bush's nomination of Dr. Crawford to become agency commissioner unless the F.D.A. made a decision on the pill, for or against. Mr. Bush has long been aligned with abortion opponents.

The senators relented in July after the secretary of health and human services, Michael O. Leavitt, promised that a decision would be made by Sept. 1. On Friday, both senators attributed Dr. Crawford's latest announcement to political interference.

Dr. Robert Fenichel, a former deputy division director for cardiovascular and renal drugs who left the F.D.A. in 2000, agreed, saying the agency's decisions on Plan B were being driven by abortion politics.

"I've never seen anything like this before," Dr. Fenichel said.

That the Plan B fight is politically charged is nothing new, of course. During Dr. Crawford's confirmation hearings, Senator Orrin G. Hatch, Republican of Utah and a supporter of Dr. Crawford, called it not "a pharmaceutical issue as much as it's a social issue."

Nor is it new that politics would play an important role in the decisions of the F.D.A. or any other politically appointed regulatory agency. Elliott Millenson, former president and chief executive of Direct Access Diagnostics, a company that sought to sell an at-home test for H.I.V. infection in the 1980's and 90's, recalled that when gay rights groups opposed the test, the agency initially refused even to accept the company's application. "The commissioner's office explicitly told us in 1992 that if we wanted approval we would need to get political support for our product," Mr. Millenson said.

He sued the agency and won. The agency eventually approved the test, although for business reasons the company never sold any.

"On sensitive issues, politics are business as usual at the F.D.A.," Mr. Millenson said.

The agency approved Plan B as a prescription contraceptive in July 1999. The pill provides a concentrated dose of the medicines available in most daily birth control pills; it can prevent pregnancy if taken as long as 72 hours after intercourse. Many abortion opponents view it as tantamount to abortion.

The F.D.A.'s announcement on Friday led to open bickering between abortion rights advocates and Barr executives. Publicly, the two sides have been supportive of each other for nearly two years, but privately, they have long disagreed on strategy.

In May 2004, the food and drug agency rejected Barr's application to sell its drug over the counter, saying the company had failed to provide enough information about how well girls younger than 16 understood the drug's label and whether they might engage in riskier sex if the drug was easily available.

At that point, Barr had two choices. It could have undertaken another "label-comprehension" study with scores of young teenagers and then resubmitted an almost identical application. Or it could have used the data that it had on hand and reapplied to sell the drug as an over-the-counter pill only to women 16 years of age and older. Younger girls would have to get a prescription. On Friday, the agency changed the age to 17.

Kirsten Moore, president of the Reproductive Health Technologies Project, an abortion rights advocacy group here, said she and fellow advocates suggested that Barr do another label study. Barr decided to reapply with existing data. No one knows whether the advocates' strategy would have worked, but Barr's has not, at least so far.

Ms. Moore said label-comprehension studies were relatively easy, cheap and quick to perform. Most are done in malls, where researchers set up a table and ask passers-by to read a drug label and answer a few questions.

Bruce Downey, Barr's chairman and chief executive, said he did not regret the company's actions. And Dr. Carol Ben-Maimon, chief of Barr's proprietary research, said F.D.A. officials never told the company exactly what questions a new study should answer.

In addition to label comprehension, the agency voiced concerns about Plan B's effects on sexual promiscuity and sexually transmitted diseases, Dr. Ben-Maimon said. To answer those questions, a quick study at a mall would not suffice, she said.

Dr. Crawford said Friday that the F.D.A. would seek public comments over the next 60 days on whether it had the authority to approve Barr's application and whether it could enforce any regulation that would stop girls younger than 17 from buying the pill freely.

Ms. Moore said she and other abortion-rights advocates wanted Barr to withdraw its present application, perform a label-comprehension study and then apply to sell the drug over-the-counter to women of all ages. Rejecting the application again if it contained clear data showing that young teenagers understood how to use the drug would be more difficult for the agency to justify with scientific or regulatory rationales, she said.

"It's time to call F.D.A.'s bluff," Ms. Moore added.

Mr. Downey, of Barr, said the company was considering a new label-comprehension trial and added that it would provide comments to the F.D.A. during the next 60 days.

Whether the agency will listen to those comments is unclear.

"We volunteered repeatedly to put proposals forth to the F.D.A.," Dr. Ben-Maimon said. "They didn't really seek out our opinions or thoughts on how we could implement them."

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