FDA signals Plan B move

Agency says it might allow the sale of morning-after pill over the counter

August 01, 2006|By JONATHAN D. ROCKOFF | JONATHAN D. ROCKOFF,SUN REPORTER

WASHINGTON -- In a surprise move on the eve of confirmation hearings for a permanent commissioner, the Food and Drug Administration said yesterday that it might soon allow sales of the morning-after pill to some women without a prescription.

Dr. Andrew C. von Eschenbach, the FDA's acting commissioner, asked Plan B's manufacturer to meet within the next week to discuss the possibility of over-the-counter sales of the pill to women 18 and older.

The manufacturer, Barr Pharmaceuticals Inc., has been asking the FDA to permit over-the-counter sales to women 16 years and older. In a letter, von Eschenbach asked Barr to meet about increasing the minimum age by two years.

"Assuming the issues can be addressed, we assume this process can be wrapped up in a couple of weeks," said Susan Bro, an FDA spokeswoman.

That would mark the end of three contentious years of consideration that ensnared the FDA in abortion politics. Abortion opponents had claimed that easy access to the pill would increase promiscuity while abortion-rights groups said the agency was sacrificing women's health to a conservative agenda.

Plan B is essentially a high dose of birth control. The first of two pills is supposed to be taken up to 72 hours after sex, the next 12 hours later. Unlike RU-486, which terminates a pregnancy, the regimen aims to stop impregnation from taking place.

Studies show the pill is safe and reduces the risk of pregnancy by 89 percent. Since 1999, the FDA has permitted its sale by prescription, and doctors have written more than 3.3 million prescriptions in the past two years, the company says.

Over-the-counter sales would provide a valuable option to women whose contraception failed or who didn't use contraception, said Dr. Beverly Winikoff, president of the women's public health group Gynuity Health Projects in New York City. But Moira Gaul, a policy analyst at the conservative Family Research Council, said the long-term effects of easy access to Plan B were not fully understood yet and required further study.

Barr first asked the FDA for permission to sell the drug over the counter in 2003. Two years later, Democratic Sens. Patty Murray of Washington and Hillary Rodham Clinton of New York held up the confirmation of Lester M. Crawford as FDA commissioner until receiving a promise that the agency would take action.

After his confirmation, Crawford announced the agency needed more time to study. Then he left the FDA and was replaced by von Eschenbach, whom Bush formally nominated in March. A subsequent nonpartisan congressional investigation found top FDA officials had reached their decision to reject over-the-counter sales without additional study before staff members finished their safety reviews.

Bro acknowledged that the timing of the FDA decision - a day before von Eschenbach is expected to face questions about Plan B during his confirmation hearing before the Senate Health, Education, Labor and Pensions Committee - was not a coincidence.

The hearing was "absolutely" a factor in von Eschenbach's decision to take action, Bro said. But she emphasized he was able to do so because the FDA had finished its review.

In his letter to Barr, von Eschenbach said the agency had received 47,000 public comments on over-the-counter Plan B sales and the "overwhelming majority" supported approval.

Murray and Clinton said in a conference call with reporters yesterday that they remained unconvinced that FDA was ready to take action on Plan B and vowed to continue blocking a vote on von Eschenbach's confirmation until the agency took final action.

"Fool me once - we're not going to go there again until we get a decision on Plan B," Murray said.

Clinton dismissed the letter as a ploy to get a vote on von Eschenbach's nomination. "Neither Senator Murray or I believe this is a good-faith effort to make a decision," she said.

A particular concern, Clinton said, was a line in von Eschenbach's letter to Barr telling the company it would need to assure the FDA that Plan B wouldn't be used by young girls "without the supervision of a practitioner licensed by law to administer the drug."

Sen. Barbara A. Mikulski, a Democrat from Maryland, sounded similar skepticism. "The FDA's decision is designed to influence President Bush's nomination, not an important policy issue," she said in a statement.

Liberal advocates worried the company wouldn't be able to make that guarantee and that a final resolution would fall through.

But Wendy Wright, president of the conservative Concerned Women for America, feared the opposite: that the FDA would grant approval and adults would buy the drug for use by teenage girls.

"I'm disappointed with the FDA and whoever was involved with this decision. It appears they're buckling to political pressure," Wright said.

Health and Human Services Secretary Michael O. Leavitt issued a statement describing FDA's move as a "good faith effort" by von Eschenbach to resolve the issue and calling on the Senate to now "move his confirmation forward."

A vote on von Eschenbach's nomination is not scheduled for tomorrow but might be considered after members return from August recess in September if the FDA makes a decision by then, said Craig Orfield, the committee spokesman.

Clinton and Murray suggested they would not object if the minimum age for over the counter sales were raised to 18 years.

jonathan.rockoff@baltsun.com

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