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FDA rejects non-prescription morning after pill

The government rejected over-the-counter sales of morning after birth control because of concern about young teen-agers’ use of the pills. But regulators left open the possibility they will reconsider.
/ Source: The Associated Press

The government rejected over-the-counter sales of morning-after birth control on Thursday because of concern about young teenagers’ use of the pills. But regulators left open the possibility they will reconsider.

The Food and Drug Administration was under intense political pressure from both sides on whether to lift the prescription requirement for emergency contraception. Conservatives argued doing so could encourage unsafe sex. Proponents said easier access to the pills could prevent thousands of abortions — and the FDA’s own scientific advisers had overwhelmingly backed the change.

Concern over use by teens
But in a letter to Barr Laboratories late Thursday, the FDA said there was no evidence teens younger than 16 could safely use the pills without a doctor’s guidance — and it thus was rejecting the move until Barr could provide that evidence.

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 anyone younger to have a doctor’s prescription.

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 exactly 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.”

'The door's open'
Barr chief executive Bruce Downey said in an interview that the company would rapidly pursue one or both of those options — even as it more actively advertises the prescription version of its morning-after brand, called Plan B, so more women know it’s an option.

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

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.