Day-after pill sales intensely lobbied

Over-counter availability up for FDA decision soon

Activists link issue to abortion

August 25, 2005|By Jonathan D. Rockoff | Jonathan D. Rockoff,SUN NATIONAL STAFF

WASHINGTON - Liberal and conservative groups have stepped up their lobbying in the days before the Food and Drug Administration is expected to announce whether to allow sales of a "morning-after" contraceptive pill without a prescription.

In what they call one of the most highly politicized FDA issues in years, the advocates are urging supporters to contact the White House and FDA Commissioner Lester M. Crawford in advance of the decision on the pill, known as Plan B.

The FDA says it decides whether to approve based on a drug's tested safety and effectiveness. But the last-minute frenzy suggests the degree to which interest groups, at least, believe the FDA's decision-makers can be pressured to consider factors beyond science.

Ted Miller, a spokesman for NARAL Pro-Choice America, said his group is urging hundreds of thousands of members to send a petition to the agency in support of over-the-counter sale of Plan B.

Likewise, conservative advocates argue that a flurry of e-mail, letters and calls might prompt President Bush's aides to put pressure on the FDA, which is expected to announce a decision by next Thursday, to reject nonprescription sales.

"The White House is where you want to pressure the FDA - they're more politically sensitive," said Colleen Parro, executive director of the Republican National Coalition for Life, which recently issued an e-mail alert urging 4,000 activists around the country to call the White House.

High-profile issue

Political interest groups say there's no other agency matter that has attracted their attention like the morning-after pill, at least since the approval of the abortion drug RU-486 five years ago.

Their recent alerts ask supporters to e-mail, write and call the White House or the FDA commissioner's office.

By mid-June, the FDA had received more than 17,400 letters, and advocates say more are coming.

An FDA spokeswoman, Suzanne Trevino, said: "We value public input, but we make our decision based on science."

In 2003, Plan B's manufacturer asked the FDA to approve over-the-counter sales. But a top agency official rejected the request, pointing to concerns that teenage girls wouldn't be able to take it safely.

Decision delayed

The manufacturer, Barr Laboratories, then asked for approval for females 16 or older. The FDA missed a statutory deadline for making a decision on that request, prompting liberal groups to complain that it was delaying because of political pressure from social conservatives.

Earlier this summer, Democratic Sens. Hillary Rodham Clinton of New York and Patty Murray of Washington held up Crawford's confirmation for weeks until a Sept. 1 deadline for a decision was set.

House Republican Leader Tom DeLay and 45 other Republican congressmen sent a letter to Crawford a month ago urging rejection of sales without a prescription.

Some advocates say the issue now matters more to them than Bush's nomination of Judge John G. Roberts Jr. for the Supreme Court.

"The Roberts nomination is seeming more and more secure, so I think people want to spend more time on issues like the morning-after pill. It's an issue where we feel we could have more political influence," said Marc Tuttle, a spokesman for Pro-Life Wisconsin.

On Monday, the anti-abortion group e-mailed 5,000 supporters, urging them to pressure the FDA.

Linked to choice

Miller, the NARAL Pro-Choice America spokesman, said the organization viewed the Supreme Court and Plan B fights as complementary: "The FDA's decision only reinforces the importance of the right to privacy and women's right to choose in this country."

The morning-after pill, which is already available by prescription, is essentially a high-dosage birth control pill taken within 72 hours of unprotected sex as an emergency contraceptive.

While part of the debate over the drug echoes arguments over abortion, both sides are emphasizing positions with crossover appeal. Supporters of over-the-counter sale say it would reduce abortions; opponents say it would increase the spread of sexually transmitted diseases.

Advocates for each side also invoke science to support their position. Liberal groups stress that Plan B has been proven safe and effective and that the FDA's staff and expert panels have recommended approval. Conservatives say studies haven't examined the long-term effects of the drug's use or its impact on teenage girls.

Undercut opponents

"The people in the FDA who are making the decision may not care whether a drug kills an unborn child," said Wendy Wright, senior policy director at the conservative Concerned Women for America, which e-mailed its 80,000 members yesterday. "And it helps to undercut our opponents."

Adapting arguments normally associated with consumer groups, Wright expresses concern that the FDA will support over-the-counter sales of the morning-after pill under the sway of a sales-hungry manufacturer and will discover too late that the drug causes serious harm.

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