Company makes second attempt at nonprescription morning-after pill
Thursday, July 22nd 2004, 1:36 pm
By: News On 6
WASHINGTON (AP) _ A maker of morning-after birth control asked the government Thursday to reconsider allowing over-the-counter sales of the pills _ but only for women 16 and older.
The Food and Drug Administration in May rejected nonprescription sales of emergency contraception, overruling its own scientific advisers, who had overwhelmingly called easier access to morning-after pills a safe way to prevent thousands of abortions.
The FDA argued that its decision reflected concern about how young teenagers might use the pills. Agency officials pledged to reconsider if manufacturer Barr Laboratories either provided data on young teens' use _ or proposed a way to sell over-the-counter only to those 16 and older.
The FDA has never formally approved such a mixed-marketing approach, which would require drugstores to check customers' ages. But Barr, maker of the Plan B emergency contraception brand, on Thursday sent the FDA a formal application to try. Under the proposal, younger teens could continue to buy Plan B with a doctor's prescription, as they can today, while older teens and adults skipped that step.
``Our counsel does believe we have found a way to do that'' that meets all FDA regulations, said Barr spokeswoman Carol Cox.
The FDA doesn't usually comment on drug applications, but the agency by law will have six months to review Barr's application and make a decision.
Until then, Plan B remains available as a prescription product for all ages except in six states _ Maine, California, Washington, Alaska, Hawaii and New Mexico _ that already allow women to buy morning-after pills from certain pharmacists without the doctor's note.
The morning-after pill is a higher dose of regular hormonal contraception. Taken within 72 hours of unprotected intercourse, it can cut a woman's chances of pregnancy by up to 89 percent. But it can be hard to find a doctor to write a prescription in time, especially on weekends and holidays _ and the earlier it's taken, the more effective it is.
If a woman already is pregnant, morning-after pills have no effect.
Contraceptive advocates and doctors' groups say easier access could cut in half the nation's 3 million unintended pregnancies each year. In December, FDA's scientific advisers agreed, on a 23-4 vote backing OTC sales.
But the FDA came under months of intense political pressure from conservatives who argued that unfettered access could encourage teen sex.