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Did politics play role in Plan B rejection?

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The Food and Drug Administration defended its decision to reject over-the-counter sales of emergency contraception even as women's groups and medical experts accused the government agency of allowing political pressure to interfere with a public health issue.

Dr. Steven Galson, acting director of the FDA’s Center for Drug Evaluation and Research, said Friday that he had overruled an earlier recommendation by his staff and the FDA's own scientific advisors to approve easier access to so-called "morning after" pills. Galson said he based the decision on the lack of research on use by young teenagers, particularly by females between 11 and 14, without a doctor's guidance.

"There was no data concerning that age group where we know there is a substantial amount of sexual activity," Galson told reporters.

Barr Laboratories, maker of the Plan B emergency contraception brand, was warned in February of the FDA's concern about underage usage. In response, Barr offered a proposal to allow nonprescription sales to anyone 16 and older — and make drugstores check ages and require a prescription from younger teens, the company said.

Galson said Friday he was unable to complete a review of the last-minute proposal.

FDA may revisit issue
The FDA left open the possibility of making morning after pills available without a prescription at a later time. In a letter of non-approval sent to Barr Labs late Thursday, the FDA had urged the drug company to provide additional data showing that Plan B can be used safely by women under 16 without medical supervision.

"We're going to be working towards the expeditious evaluation of Barr’s response," Galson said. "If the product is approved for nonprescription use, it would dramatically increase access to all contraceptives and would represent an important, incremental step forward to the availability of contraception in the U.S. We think this is very important to public health."

But the president of a women's group accused the FDA of "betraying the public health mandate."

"I cannot understand how one officer at the FDA can overrule the advice of his own expert advisory committee and his staff. To us this decision smacks of political interference," said Kirsten Moore of the Reproductive Health Technologies Project, a nonprofit organization based in New York. "We believe the public health benefits of making this widely available far outweigh the risks."

In a statement Friday, the American College of Obstetricians and Gynecologists called the FDA's decision "morally repugnant."

'A tragedy for American women'
"The FDA's action is a tragedy for American women, and a dark stain on the reputation of an evidence-based agency like the FDA," wrote Dr. Vivian Dickerson, president of the medical group.

Emergency contraception is a concentrated dose of birth control pills used by women after unprotected sex. If taken within 72 hours of sexual intercourse, the hormone pills can reduce the chances of getting pregnant by up to 89 percent. Proponents suggest that half of the estimated 3 million unintended pregnancies each year could be prevented by easier access to emergency contraception like Plan B.

If a woman already is pregnant, morning-after pills have no effect.

Emergency contraception has been available by prescription in the United States since 1998 and is considered safe and highly effective by doctors' groups.

In December 2003, the FDA’s scientific panel agreed, voting 23-4 in favor of it being sold without a prescription.

Since the December vote, the FDA has met with intense political pressure from conservatives and religious groups who argue that easy access to emergency contraception would result in more teen promiscuity. A group of 49 conservative members of Congress sent a letter to President Bush and FDA Commissioner Mark McClellan urging the agency to reject the panel’s recommendation.

Galson repeatedly insisted Friday that he had not been swayed by political influence from the White House, maintaining that he consulted only with the FDA commissioner and his internal staff.

"We get letters from Congress. We read the letters...But they’re not what helps us make the decision," he said. "The decision I made had to do with looking at all the data and looking at all the transcripts [of the advisory committee hearings]."

Women's health advocate Dr. David Grimes of Family Health International in Durham, N.C., countered that the FDA's decision was "based on ideology and not on science."

"There is clear and uncontrovertible evidence that [Plan B] is safe," he said.

Conservatives welcomed the decision.

“The FDA is siding with our nation’s teens and their health,” said Rep. Dave Weldon, R-Fla., a doctor.

“The FDA is right to be cautious about having a potent drug that can harm women next to candy bars and toothpaste,” said Wendy Wright of Concerned Women for America, a group that opposes abortion.

Within the FDA, reaction to the decision was mixed. An internal agency memo, obtained by The Associated Press, suggests medical reviewers backed nonprescription sales but were overruled by senior officials.

“Some staff have expressed the concern that this decision is based on non-medical implications of teen sexual behavior, or judgments about the propriety of this activity,” said Galson’s memo. “These issues are beyond the scope of our drug approval process, and I have not considered them in this decision.”

It's unusual, but not unprecedented, for the FDA to override an advisory committee's recommendation.

"I didn’t concur with the recommendation of the staff in making this decision," Galson said Friday.

Company to keep pushing for approval
Barr Labs said it would continue to work with the FDA to gain nonprescription approval of Plan B, possibly within the next year. Spokeswoman Carole Cox said the company would now decide whether to conduct additional research on younger teens or focus on the over-16 market. Either option would require re-submitting data and waiting six months for another FDA review.

Meanwhile the company will continue to market Plan B as a prescription product through education campaigns for medical professionals and consumers.

"We're not going to sit still while we work with the FDA," said Cox.

Studies on college campuses show a decline in pregnancy and abortion with wider availability of the morning after pill.

To improve access, five states — California, Washington, Alaska, Hawaii and New Mexico — already allow women to buy morning after pills from certain pharmacists without a prescription. The FDA’s decision does not affect those programs.

Fallout from the FDA's decision is only beginning, Plan B proponents say. Women's health advocates say they will continue to push for over-the-counter status.

"We will keep the pressure on both the company and the FDA to meet the challenge to get this done quickly," said Moore. "We'll do what we can to remind women that it’s a safe product and its time sensitive.