WASHINGTON -- Federal health officials are debating if it's timeto put emergency contraception -- also called the morning-afterpill -- on pharmacy shelves right next to the aspirin, availablewithout a prescription.
Proponents say such a move would greatly increase women'sability to get the pills in time to prevent pregnancy: preferablywithin 24 hours but no more than 72 hours after rape, contraceptivefailure or just forgetting birth control.
The Food and Drug Administration says emergency contraception isvery safe to use, but the question is whether women will understandexactly how and when to take it without any professionaladvice.
Indeed, the morning-after pill marks the first in a series ofever more complex over-the-counter switch decisions facing FDA.Next year, the agency will be asked to allow nonprescriptionMevacor, one of the popular cholesterol-fighting statins; itexpects to eventually consider over-the-counter blood pressuremedicine, too.
And as OTC drugs evolve from quick symptom relief to morecomplex therapy, the FDA is mulling whether it's also time tochange how some of them are sold -- perhaps beginning''behind-the-counter'' sales for certain nonprescription drugs,where the pharmacist hands over the pills after giving healthadvice or, say, a cholesterol check.
Already, five states allow women to buy the morning-after pilldirectly from certain pharmacists without a doctor's prescription.The state programs -- in Washington, California, Alaska, Hawaii andNew Mexico -- aim to increase access to emergency contraception,especially on weekends and holidays when finding a doctor in timeis particularly hard.
Now the maker of one emergency contraceptive brand, called PlanB, has asked the FDA to go further and allow the pills to sellover-the-counter nationwide, as is done in numerous othercountries.
FDA's scientific advisers will debate the request next month. IfFDA ultimately does end the requirement for a doctor'sprescription, the question becomes whether Plan B can sit on anydrugstore shelf next to the cold remedies, or if the governmentprefers behind-the-counter access like in Washington and the otherfour states. A senior FDA official says all options are open.
Contraception advocates are pushing hard for no restrictions.They say easy over-the-counter access could spur wider use ofemergency contraception, in turn preventing up to 1.7 millionunplanned pregnancies each year and hundreds of thousands ofabortions.
''Emergency contraception is extremely safe. It needs to be onthe shelf beside aspirin,'' says Dr. Vanessa Cullins of PlannedParenthood.
Morning-after pills are higher doses of the hormones in regularbirth control pills, and have been sold under the brand names PlanB and Preven since 1998. Use is growing slowly: a Kaiser FamilyFoundation survey last summer found 6 percent of women ofchildbearing age had used morning-after pills, up from 2 percent in2000.
Taken within 72 hours of unprotected sexual intercourse, thepills are at least 75 percent effective at preventing pregnancy.They work by preventing ovulation or fertilization of an egg. Iffertilization already has occurred, they prevent the egg fromimplanting into the uterus -- the medical definition ofpregnancy.
If a woman already is pregnant, emergency contraception won'thave any effect. So it hasn't proved nearly as controversial asRU-486, the abortion pill.
But emergency contraception does have opponents, including theVatican, who oppose any interference with a fertilized egg. Criticscontend if regular birth control pills are too risky fornonprescription use then emergency use is, too -- and that broaderaccess to emergency contraception actually could increase sexuallytransmitted diseases.
''You will have people ... falling back on this idea we'll alljust go to the drugstore in the morning and get a morning-afterpill,'' says Wendy Wright of Concerned Women for America, anorganization that opposes abortion.
There's no evidence that access to emergency contraception makeswomen more careless about regular contraception, says Dr. FeliciaStewart of the University of California, San Francisco's Center forReproductive Health Research & Policy.
Still, it's a question FDA will consider. As for side effects,the quick-ending hormone dose from emergency contraception doesn'tcause problems like blood clots that longtime use of regularbirth-control pills can, says FDA drug chief Dr. John Jenkins.
''It's proven to be very safe,'' he said. ''The fundamentalthing we'd be looking at is ... do the women understand theinstructions'' and take it properly.
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