Jewish World Review April 29, 2003 / 27 Nisan, 5763


FDA asked to make 'morning-after' pill over-the-counter

By Katrina Woznicki

http://www.NewsAndOpinion.com | (UPI) A small pharmaceutical company said it would ask the Food and Drug Administration to permit the over-the-counter sale of its emergency contraceptive pill, a move that anti-abortion advocates said they would fight.

The pill, manufactured by Women's Capital Corporation, is called Plan B and was approved by the FDA for prescription use in 1999. It contains the same hormones found in other oral contraceptives, except at higher doses, and can prevent pregnancy if taken within 72 hours after unprotected sexual intercourse occurs.

"Women are having difficulty getting a prescription and getting it filled within the 72 hours they need to start treatment," Sharon Camp, WCC's founder and chief executive officer, told United Press International. "It really needs to be out there on the shelves on the ... morning after the condom breaks. I don't see why anyone would be opposed to it. This is not an abortion pill. It's an anti-abortion pill. It will prevent pregnancy, and if we can prevent pregnancy, we will prevent abortions."

WCC, which is located in Washington and was founded in 1997, has submitted a 15,000-page application to the federal government containing clinical data on almost 11,000 women who have used the progestin-based pill. The studies show when used correctly, Plan B reduces the risk of pregnancy by 89 percent and is most effective when used within 24 hours after unprotected sex. The treatment, dubbed the "morning-after pill," works by preventing a fertilized egg from attaching to the womb.

Camp said if the FDA approves her company's application, women could see Plan B available on store shelves as early as next year.

"This product passes the test," Kristin Moore, president of Reproductive Health Technologies Project, an advocacy group based in New York City, told UPI. "It can be safe enough without a doctor's prescription. All things being equal, we expect this to be received well. Within a year is a real possibility."

There will be political hurdles to overcome, however. Judie Brown, president of the American Life League, an anti-abortion organization headquartered in Stafford, Va., said her group and others will lobby the FDA to prevent emergency contraceptives from selling over the counter.

"Plan B is one of the highly marketed products by Planned Parenthood and other pro-abortion groups," Brown told UPI. "I don't see any reason why the FDA would provide over-the-counter access to a chemical that can kill people. It's a human embryo whose life is taken by these pills."

Brown added, "I see the FDA making an effort to act responsibly on what it does on behalf of mothers and I see the FDA, therefore, rejecting this proposal."

Dr. Jeffrey Waldman, medical director for Planned Parenthood and a physician in Shasta-Diablo, Calif., said the anti-abortion groups are ignoring the science behind emergency contraception.

"It would be really interesting, wouldn't it, if we could base this on science and not the politics," Waldman told UPI. Emergency contraception pills do not destroy embryos, Waldman explained. Instead, they prevent the pregnancy from starting in the first place because pregnancy cannot begin until a fertilized egg has attached itself to the uterus. When the egg fails to attach to the uterus, there is no pregnancy, he said.

Although the pill is most effective if used within hours of unprotected sex, Waldman said studies have shown it still works even five days later.

Perhaps more important, he said, if a woman takes the morning-after pill but already is pregnant unknowingly -- even for a few weeks -- the clinical data show it would not harm the already developing fetus or the mother. That is why the pill makes a good candidate for over-the-counter use, he said.

"If it's over the counter and inappropriately used, which would happen, there's no negative consequences to that," Waldman said. "There's no untoward event either to the mother or the fetus (by inadvertently taking) this medication. That's the protection. Let the science speak for itself."

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