- The Washington Times - Thursday, May 6, 2004

The government rejected over-the-counter sales of morning-after birth control yesterday because of concerns about young teenagers’ use of the pills.

Regulators, however, did leave open the possibility that they will reconsider the sale of the drug.

The Food and Drug Administration had been under intense political pressure about whether to lift the prescription requirement for emergency contraception, with conservatives arguing that doing so could encourage sexual promiscuity.

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

“The FDA is siding with our nation’s teens and their health,” said Rep. Dave Weldon, Florida Republican and a physician in private life.



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, never has been tried. The FDA said the company did not provide many details, making it impossible to decide whether such a program would be legal and doable.

Proponents said easier access to the pills could prevent thousands of abortions — and the FDA’s scientific advisers had backed the change in a 23-4 vote in December. Kirsten Moore of the Reproductive Health Technologies Project accused the FDA of bowing to political pressure.

“The decision blatantly disregards the overwhelming scientific evidence,” she said. “But the Bush administration has denied American women timely access to a safe, proven second chance to prevent pregnancy.”

Democratic presidential candidate Sen. John Kerry criticized the move through a spokesman.

“The White House is putting its own political interests ahead of sound medical policies that have broad support,” campaign spokesman Phil Singer said.

But yesterday, FDA officials left open the door for Barr to try again, telling the company what information they would need to reconsider their decision. Barr would have to either show that young teens could use the pills safely without a prescription or provide 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 the company rapidly would pursue one or both of those options — while it more actively advertises the prescription version of its morning-after brand, called Plan B.

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

An agency memo, obtained by the Associated Press, suggests medical reviewers backed nonprescription sales of Plan B, but were overruled by senior officials.

“Some staff have expressed the concern that this decision is based on nonmedical 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.”

Dr. 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.”

Wendy Wright, senior policy director for the pro-life group Concerned Women for America, said the FDA was “right to be cautious about having a potent drug that can harm women next to candy bars and toothpaste.”

The morning-after pill is 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.

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