FDA APPROVES FIRST `MORNING-AFTER' PILL

NEWARK, N.J. (AP) -- The Food and Drug Administration today allowed
the first-ever sales and marketing of a kit of emergency contraceptive
pills that women can take the morning after unprotected sex to prevent
pregnancy.

The PREVEN kits will be available by prescription by the end of
September, said Roderick Mackenzie, chairman and founder of Gynetics
Inc of Somerville, N.J., which won the first approval to advertise and
sell morning-after pills.

The FDA has long told women, and doctors, how to use standard birth
control pills in this manner, and the agency last year gave out
specific information about which pills and dosages were effective as
contraception up to 72 hours after unprotected sex.

But today's approval, for the first time, allows a pharmaceutical
company to advertise and to sell special morning-after packets that
women can keep in their medicine cabinets.

``It's not only a scientific but an ethical advance,'' said Arthur
Caplan, director of the Center for Bioethics at the University of
Pennsylvania. ``Women now have more options, and have long deserved to
have the rights to prevent unplanned pregnancies.''

Anti-abortion groups, however, have criticized the method.

The morning-after pills are different from RU-486, the French abortion
pill, which actually ends a pregnancy several weeks after it has begun.

Gynetics had said the company would market the emergency kit last
year, becoming the first U.S. company to take action since the FDA
approved using contraceptive pills for emergency birth control.

In February 1997, the FDA said six brands of birth control pills were
safe and effective as morning-after pills, the first federal
acknowledgment of the emergency birth control method that European
women have been prescribed for years.

Until now, however, contraceptive manufacturers have refused to sell
the form of emergency birth control here, citing litigation and
political fears.

The pills prevent or delay ovulation, experts said. Some say the pills
could possibly prevent a fertilized egg from implanting in the uterine
wall so it can grow into an embryo.

If an embryo is already implanted and growing, the morning-after pills
will have no effect -- unlike with RU-486.

The FDA said the regimen is effective 75 percent of the time. It
consists of taking two oral contraceptive pills within 72 hours of
unprotected sex, and another two pills 12 hours later.

For every 100 women who have unprotected sex during the second or
third week of their menstrual cycle, eight would normally become
pregnant -- but only two would if the women took the emergency birth
control, according to studies.

The emergency contraceptive's side effects are nausea and vomiting,
sometimes severe. More than 4 million women have taken emergency
contraception in Britain alone, and studies there have shown no
serious side effects.

Checked-by: Patrick Henry