Monday, August 07, 2006



August 1, 2006 Edition > Section: National
Bush May Okay Morning After Pill Without Rx
BY JOSH GERSTEIN - Staff Reporter of the Sun
August 1, 2006

In a snub to anti-abortion groups, the Bush administration is signaling that it is prepared to act soon to allow adult women to buy the so-called morning after pill without a prescription if a system can be devised to limit access to minors.

The move toward easier availability of the drug, known as "Plan B," came on the eve of today's Senate confirmation hearing for the administration's nominee for Food and Drug Administration commissioner, Andrew von Eschenbach.

The development, contained in a press statement and letter the FDA sent to the drug's manufacturer yesterday, seemed aimed at clearing the way for Dr. von Eschenbach's confirmation, which has been held up over the issue by Senator Clinton and Senator Murray of Washington.

However, the FDA's action was greeted with suspicion by both sides of the abortion debate. The two Democratic senators said they had no intention of allowing the nomination to go forward until the agency makes a final decision on the matter.

"They're just slow-walking this," Mrs. Clinton told reporters during a conference call yesterday. "They're just trying to have a process that can get the nominee through the political confirmation hearings."

The senators said they felt burned after they released holds last year on another FDA nominee, Lester Crawford, in exchange for an administration pledge to make a quick decision about Plan B. "They said they made a decision, and their decision was not to make a decision," Mrs. Clinton said.

"Fool me once. We're not going to go there again," Mrs. Murray said. "We just don't believe them."

While Mrs. Clinton said pressure from the White House was behind the agency's years of delays, a Republican abortion rights opponent, Senator Coburn of Nebraska, suggested political considerations triggered yesterday's announcement.

"The Bush administration's policy on the morning after pill should be based on protecting the health of women, not their nominees," Dr. Coburn, who is a physician, said. "Bowing to short-term political concerns in this debate could endanger the health and safety of thousands of Americans."

Anti-abortion groups contend that the drug is unsafe and far riskier than traditional birth control pills, which still require a prescription. At least five deaths have been linked to Plan B in America.The drug's backers claim that the rate of complications is similar to or lower than that of surgical abortion or pregnancy.

In the new letter, Dr. von Eschenbach, who is serving as the FDA's acting commissioner, said the agency wanted more information about how the manufacturer, Barr Pharmaceuticals, planned to ensure that pharmacies would confirm the age of women seeking to purchase the pill over the counter.

"We are very interested in learning how you plan on enforcing the restrictions if a pharmacy fails to comply with them," Dr. von Eschenbach wrote.

In a written statement, the FDA said approval for over-the-counter marketing of Plan B could take place in short order. "The agency hopes that as both sides are committed to working diligently through these issues, the process can be wrapped up in a matter of weeks," the statement said.

The morning after drug was approved for use with a doctor's prescription in 1999. In 2003, the company proposed making the medication available for over-the-counter purchase by those 16 or older. Last year, the FDA's drug safety office said it would be safe to allow direct access by those over 17. In the latest letter, Dr. von Eschenbach moved the bar up another year.

"Because of enforcement considerations, we believe that the appropriate age for OTC access is 18," he wrote.

A spokeswoman for an organization opposed to Plan B, the Family Research Council, said the age limit was unlikely to work. "The FDA doesn't have the enforcement authority to say store clerks are checking age IDs," the spokeswoman, Moira Gaul, said.

Age limits on over-the-counter drugs are rare, but not unheard of. When the FDA allowed nicotine patches and gum to be sold without a prescription, it restricted sales to people 18 and over.

While the FDA has not yet cleared Plan B for nonprescription use, at least six states allow pharmacists to prescribe the drug without a physician's involvement. While popularly known as the morning after pill, it can be taken immediately following unprotected sex or the failure of another birth control method and for up to three days thereafter. The medicine, which is a higher dose of hormones used in some birth control pills, averts pregnancy by preventing implantation of a fertilized egg.

A Government Accountability Office study released last year found that political appointees at the FDA had overruled staff scientists and outside advisory panels in blocking immediate access to Plan B.

Mrs. Clinton and Mrs. Murray insisted that they were not pushing the FDA to act one way or another but simply to act. "This could go on with the same song and dance that we've seen for over three years," Mrs. Clinton said.

Under Senate custom, senators can delay floor action on a nomination indefinitely. Such holds can be overridden, but that is rare.

August 1, 2006 Edition