FDA Rejects OTC Morning-After Pill Sales
LAURAN NEERGAARD, AP Medical Writer, WASHINGTON 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.
But in a letter to Barr Laboratories late Thursday, the FDA said there wasn't yet proof that 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 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.
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