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FDA Won't Allow Over The Counter Sales of "Morning After" Pill

by Steven Ertelt
LifeNews.com Editor
May 7, 2004

Washington, DC (LifeNews.com) -- In a decision that is receiving praise from pro-life organizations, the Food and Drug Administration decided late Thursday that it will not allow over-the-counter sales of the so-called morning after pill. Pro-life groups oppose the use of the drug because it is dangerous for women and can sometimes cause abortions.

The FDA made its decision based on concerns about the effects of the drug on teenagers. However, it left the door open to allowing the drugs to be sold to adults.

The agency also said it would reconsider its decision if Barr Laboratories, maker of the Plan B morning after drug, would provide more details on teen's use of the drugs.

"Wide availability of safe and effective contraceptives is important to public health," FDA acting drug chief Dr. Steven Galson wrote the company. "We look forward to continuing to work with you if you decide to pursue either of these options."

The agency said Barr's main basis for approval was a study of 585 people who had used the drug. However, the FDA pointed out that only 29 of the subjects were 14-16 years old.

Barr Labs said it was disappointed by the FDA's decision. Barr chief executive Bruce Downey said his company would seek nonprescription sales approval again, but this time for people 16 years or older.

"The FDA has also provided us with pathways to a future approval, and we are committed to following the pathways until we get this product on the market over-the-counter," Downey told the Washington Post.

Downey said he expected to be able to accomplish that in a matter of months.

Pro-life groups hailed the agency's decision as a victory for women and teenagers.

Tony Perkins, president of the Family Research Council, said his group "applauds the FDA for putting the safety of American women and girls above the wishes of the pro-abortion lobby and we encourage them to hold their ground."

"Women taking the birth control pill consult with their doctors once a year for medical check-ups. The morning-after pill is 50 times stronger, and yet over-the-counter access would have allowed women and girls to take this dangerous drug without any medical oversight," Perkins added.

Cathy Cleaver Ruse, Esq., of the United States Conference of Catholic Bishops, agrees.

"A drug which can destroy human embryos and increases health risks to women and girls does not belong on the drugstore shelf," Ruse said.

Ruse said the morning after pill has been associated with a heightened risk of ectopic pregnancy, a potentially fatal condition. Medical authorities in the U.K. and New Zealand have issued warnings about the drug's dangers.

But groups advocating abortion were incensed by the FDA's decision.

Amy Allina, project director for the National Women's Health Network, a group backing abortion, told the Post, "It's quite outrageous and flies in the face of the scientific evidence."

"This has happened because of politics in this election year. They're pandering to the anti-choice extremists," Allina said.

That view isn't surprising to FRC's Perkins.

"It is worth noting that the self-described 'protectors of women's health,' the pro-abortion lobby, repeatedly calls for such decisions to be made between 'women and their doctors,'" Perkins explained. "But, in this case, they were asking for these decisions to be made between young girls and a pharmacy counter, with no accountability or safeguards in place. We are glad the FDA saw it differently."

Likely Democratic nominee John Kerry also criticized the agency's decision.

"The White House is putting its own political interests ahead of sound medical policies that have broad support," a spokesman for Kerry told the Associated Press.

The FDA decision comes after a panel of advisors had overwhelmingly recommended that the drug be approved for sale without first consulting a physician.

California, Washington, Alaska, Hawaii and New Mexico already allow women to buy the morning after drug from certain pharmacists without a prescription.

Related web sites:
Part of the FDA letter to Barr can be found at:
http://media.corporate-ir.net/media_files/nys/brl/news/fda_letter.pdf


Enter your email address to receive news from LifeNews.com via email. Do you prefer to receive news daily or weekly? Daily Weekly Do you favor or oppose abortion? Favor Oppose Click here to make a PayPal donation to LifeNews.com!	FDA Won't Allow Over The Counter Sales of "Morning After" Pill by Steven Ertelt LifeNews.com Editor May 7, 2004 Washington, DC (LifeNews.com) -- In a decision that is receiving praise from pro-life organizations, the Food and Drug Administration decided late Thursday that it will not allow over-the-counter sales of the so-called morning after pill. Pro-life groups oppose the use of the drug because it is dangerous for women and can sometimes cause abortions. The FDA made its decision based on concerns about the effects of the drug on teenagers. However, it left the door open to allowing the drugs to be sold to adults. The agency also said it would reconsider its decision if Barr Laboratories, maker of the Plan B morning after drug, would provide more details on teen's use of the drugs. "Wide availability of safe and effective contraceptives is important to public health," FDA acting drug chief Dr. Steven Galson wrote the company. "We look forward to continuing to work with you if you decide to pursue either of these options." The agency said Barr's main basis for approval was a study of 585 people who had used the drug. However, the FDA pointed out that only 29 of the subjects were 14-16 years old. Barr Labs said it was disappointed by the FDA's decision. Barr chief executive Bruce Downey said his company would seek nonprescription sales approval again, but this time for people 16 years or older. "The FDA has also provided us with pathways to a future approval, and we are committed to following the pathways until we get this product on the market over-the-counter," Downey told the Washington Post. Downey said he expected to be able to accomplish that in a matter of months. Pro-life groups hailed the agency's decision as a victory for women and teenagers. Tony Perkins, president of the Family Research Council, said his group "applauds the FDA for putting the safety of American women and girls above the wishes of the pro-abortion lobby and we encourage them to hold their ground." "Women taking the birth control pill consult with their doctors once a year for medical check-ups. The morning-after pill is 50 times stronger, and yet over-the-counter access would have allowed women and girls to take this dangerous drug without any medical oversight," Perkins added. Cathy Cleaver Ruse, Esq., of the United States Conference of Catholic Bishops, agrees. "A drug which can destroy human embryos and increases health risks to women and girls does not belong on the drugstore shelf," Ruse said. Ruse said the morning after pill has been associated with a heightened risk of ectopic pregnancy, a potentially fatal condition. Medical authorities in the U.K. and New Zealand have issued warnings about the drug's dangers. But groups advocating abortion were incensed by the FDA's decision. Amy Allina, project director for the National Women's Health Network, a group backing abortion, told the Post, "It's quite outrageous and flies in the face of the scientific evidence." "This has happened because of politics in this election year. They're pandering to the anti-choice extremists," Allina said. That view isn't surprising to FRC's Perkins. "It is worth noting that the self-described 'protectors of women's health,' the pro-abortion lobby, repeatedly calls for such decisions to be made between 'women and their doctors,'" Perkins explained. "But, in this case, they were asking for these decisions to be made between young girls and a pharmacy counter, with no accountability or safeguards in place. We are glad the FDA saw it differently." Likely Democratic nominee John Kerry also criticized the agency's decision. "The White House is putting its own political interests ahead of sound medical policies that have broad support," a spokesman for Kerry told the Associated Press. The FDA decision comes after a panel of advisors had overwhelmingly recommended that the drug be approved for sale without first consulting a physician. California, Washington, Alaska, Hawaii and New Mexico already allow women to buy the morning after drug from certain pharmacists without a prescription. Related web sites: Part of the FDA letter to Barr can be found at: http://media.corporate-ir.net/media_files/nys/brl/news/fda_letter.pdf