FDA’s decision to refuse over-the-counter access of morning-after pill is ‘solid’ and ‘scientific’

Washington D.C., May 24, 2004 / 22:00 pm

A public policy analyst with the Secretariat for Pro-Life Activities of the U.S. Conference of Catholic Bishops is defending the recent decision, made by the Food and Drug Administration, refusing to make the morning-after pill available over-the-counter.

Since the FDA’s decision, pro-abortion groups have accused the government body of having mixed politics with science and of not having based their decision on sufficient scientific evidence. They have called for an investigation into the decision process and pro-abortion members of Congress have also introduced a bill, the Science Over Politics Act. The act would require the FDA commissioner to state, under penalty of perjury, that his decision was not influenced by politics.

However, Maureen Kramlich, a public policy analyst with the USCCB, has argued that the FDA’s decision is on “solid scientific ground” and that it places “the health interests of women, especially young women and girls, above a for-profit drug company’s financial interests.”

The FDA’s concern about the impact that an over-the-counter designation would have on adolescent girls’ health is well founded, she said. 

In an article she wrote, Kramlich cited the experience of a pharmacist in the United Kingdom, where the pills are available without a prescription. The pharmacist reported that a 10-year-old girl, who had requested the pills, said she had already used the morning-after pill four times.

“Other UK pharmacists have reported seeing boyfriends lurking in the back of the store, and have expressed concerns that less assertive women and young girls are being coerced to take the pills,” said Kramlich.

The FDA made its decision based on the insufficient research done on the effects of the drug on adolescents. During an FDA meeting, the manufacturer, Barr Laboratories, admitted that there were no animal studies of the drugs’ effects on adolescents, reported Kranlich.

The FDA also considered that many women are not aware of the drug’s abortifacient properties – it blocks the implantation of an embryo in the womb – and that such information should be printed on the box.

Physicians noted that an over-the-counter designation could be used to exploit young women’s fears of becoming pregnant and that many women would take the drug unnecessarily, even in their times of infertility, said Kramlich. The designation could create a tendency for this drug to be used and sold much more than is really needed.

“One financial news Web site provided estimates that over-the-counter availability of the drugs could bring $25-$100 million in annual revenues for Barr,” wrote Kramlich.