FDA - No over-the-counter morning-after pill yet

WASHINGTON -- The government rejected over-the-counter sales of morning-after birth control Thursday, citing concern about young teenagers' use of the pills. But regulators left open the possibility they will reconsider. Proponents immediately accused the Food and Drug Administration of bowing to conservative political pressure -- noting that the agency had overruled its own scientific advisers, who had overwhelmingly called easier access to emergency contraception a safe way to prevent thousands of abortions.

In a letter to Barr Laboratories late Thursday, the FDA said there wasn't any evidence that teens younger than 16 could safely use the pills without a doctor's guidance.

The FDA had told Barr about the teen concern in February, and the company proposed allowing nonprescription sales for everyone 16 and older but requiring a prescription for anyone younger.

Such a step, which presumably would require drugstores to check customers' ages, has never been tried. The FDA said the company didn't provide many details, making it impossible to decide if such a program would be legal and doable.

But Thursday, FDA officials left open the door for Barr to try again, telling the company what information they would need to reconsider: either data showing young teens could use the pills safely without a prescription or details on how to make the mixed-marketing approach work.

"Wide availability of safe and effective contraceptives is important to public health," the FDA letter said. "We look forward to continuing to work with you if you decide to pursue either of these options."

Barr chief executive Bruce Downey said in an interview that the company would rapidly pursue one or both options -- even as it more actively advertises the prescription version of its morning-after brand, called Plan B, so more women know that taking the pills within 72 hours of intercourse can greatly reduce their risk of pregnancy.

"It's a matter of weeks and months to deal with this objection," Downey said, saying that means FDA could reconsider the issue within a year. "Clearly ... the door's open, and we plan to go through it."

Contraceptive advocates decried the decision, saying easier access to emergency contraception could have cut in half the nation's 3 million unintended pregnancies each year -- by lifting barriers to women getting them in time after rape, contraceptive failure or just not using regular birth control.

"The decision blatantly disregards the overwhelming scientific evidence," said Kirsten Moore of the Reproductive Health Technologies Project. "But the Bush administration has denied American women timely access to a safe, proven second chance to prevent pregnancy."

The FDA's move will "have a negative impact on the public health," said Dr. Alastair Wood of Vanderbilt University, one of the FDA advisers who voted 23-4 in December to back the nonprescription switch.

Noting that emergency contraception is sold without a prescription in numerous other countries, he added: "It seems a tragedy to me that American women don't have the same access to effective drugs that English and Canadian women do."

Conservatives who had argued to FDA that easier access to Plan B would encourage teen sex lauded the decision.

"The FDA is siding with our nation's teens and their health," said Rep. Dave Weldon, R-Fla.

Within the FDA, the decision was mixed. An internal agency memo, obtained by The Associated Press, suggests medical reviewers backed nonprescription sales of Barr's brand, called Plan B, 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 the memo, written by FDA acting drug chief Dr. Steven Galson. "These issues are beyond the scope of our drug approval process, and I have not considered them in this decision."

Galson noted that some 11- to 14-year-olds are sexually active but that "despite the urgent need to prevent pregnancy in these young adolescents, the application contained no data in subjects under 14 years of age."

The memo pledged that Galson "will be working toward the expeditious evaluation of Barr's proposed access plan when we receive a complete version."

The morning-after pill is simply a higher dose of regular hormonal contraception. Taken within 72 hours of intercourse, the pills cut the chances of getting pregnant by up to 89 percent.

The sooner they're taken, the more effective they are. But it can be hard to find a doctor to write a prescription in time, especially on weekends and holidays.

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