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Produced for LMC-TVbyFran Snedeker |
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Produced for LMC-TVbyFran Snedeker |
August 13, 2005
By LAURAN NEERGAARD
AP Medical Writer
WASHINGTON - By month's end, federal health officials will decide whether
to let women buy emergency contraception without a prescription - and
if so, if the morning-after pill will be treated more like aspirin off
the shelf or like cigarettes.
Regardless of how the Food and Drug Administration ends the two-year
saga, it isn't likely to settle the issue. States already are moving
to expand access to Plan B, the pill that can prevent pregnancy if taken
soon after unprotected sex, amid some competing efforts to restrict it.
And if the FDA does allow easier access, the pills probably would come
with an age limit - anyone younger than 16 would still need a prescription.
So drugstores would have to "card" young customers seeking
to prevent pregnancy much as they now check cigarette buyers' ages.
How is unclear. Would morning-after pills sit next to other over-the-counter
drugs or condoms? Cash registers could be programmed to block purchase
pending an age check. That's doable: Walgreen's, the nation's largest
drugstore chain, just last month took that step to prohibit sales to
minors of cold medicines containing a sometimes-abused ingredient.
Or would the contraceptive be treated like cigarettes, put behind cash
registers as a reminder against teenage sales?
Or would morning-after pills be sold only "behind the counter," meaning
the pharmacist still must hand them over even though no doctor's prescription
is required?
Laws in seven states - Alaska, California, Hawaii, Maine, New Hampshire,
New Mexico and Washington - already allow women to buy Plan B that way,
with no age restrictions. Massachusetts is set to become the eighth this
fall, as lawmakers are expected to override their governor's veto of
nonprescription sales.
Whether drugstores even agree to carry nonprescription Plan B will depend
largely on whether such steps are required.
"
A lot of it is going to be the ease with which it can be handled in the
retail store," says Mary Ann Wagner of the National Association
of Chain Drug Stores.
If FDA rejects nonprescription sales nationally, the small but growing
Plan B state rebellion is sure to continue. It's legal for states to
allow behind-the-counter sales because states, not the federal government,
regulate how pharmacists practice, explains Dr. Alastair Wood of Vanderbilt
University, a well-known pharmacologist who advises the FDA.
Still, Wood says conflicting state policy over a drug long considered
safe makes little sense.
Plan B contains a higher dose of the hormones in regular birth control
pills. It cuts the chances of pregnancy by up to 89 percent if used within
72 hours of rape, condom failure or just forgetting routine contraception.
The earlier it's taken, the more effective it is. But it can be hard
to find a doctor to write a prescription in time, especially on weekends
and holidays. Hence the push to allow nonprescription sales here, just
as in Britain and Canada.
If a woman already is pregnant, the pills have no effect. They prevent
ovulation or fertilization of an egg; they also may prevent the egg from
implanting into the uterus, the medical definition of pregnancy, although
recent research suggests that's not likely.
Contraceptive advocates and doctors' groups say easier access could halve
the nation's 3 million annual unintended pregnancies. FDA's own scientists
call the pills extremely safe, used by more than 2.4 million Americans
and millions more women abroad with few side effects. FDA's independent
scientific advisers overwhelmingly backed over-the-counter sales in December
2003.
But FDA rejected that move, citing concern about young teens' use of
the pills without a doctor's guidance.
Maker Barr Laboratories reapplied, asking that women 16 and older be
allowed to buy Plan B without a prescription while younger teens continue
to get a doctor's note. When FDA missed a January deadline to decide,
members of Congress refused to seat the agency's new commissioner until
he pledged a new deadline - Sept. 1.
Opponents argue that unfettered access to Plan B could increase teen
sex and are pushing states to restrict prescription access, too, such
as by blocking requirements that emergency rooms or pharmacies sell it.
If the drug is sold without a prescription, FDA has no way to enforce
an age restriction, says Wendy Wright of the conservative Concerned Women
for America. "The person who buys the drug is not necessarily the
person who takes the drug," she says. "It's a ludicrous proposal."
Plan B's proponents don't like the age restriction, either, saying teens
are most in need of a second chance at avoiding pregnancy - and that
there's no evidence easier access increases teen sex or makes women of
any age more careless about regular contraception.
If FDA rejects even age-staggered nonprescription sales, Planned Parenthood
may sue, says president Karen Pearl.
"
The FDA really ignored the scientific evidence," Pearl says. "This
is absolutely the best way of assuring that when something does go wrong,
that people have that second opportunity to prevent the unintended pregnancy."
(© 2005 by The Associated Press. All Rights Reserved.)