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FDA Puts Women's Interests Over Profits


by Maureen Kramlich

May 21, 2004

Ever since the Food and Drug Administration (FDA) wisely declined to make Plan B "morning-after" pills available over-the-counter, pro-abortion groups have reacted hysterically. The groups charge the FDA with injecting politics into science. Planned Parenthood is calling for an investigation into the FDA. And pro-abortion members of Congress introduced a bill, the "Science Over Politics Act," to require the FDA commissioner to state under penalty of perjury that his decision was not influenced by politics.

In fact the FDA is on solid scientific ground — putting the health interests of women, especially young women and girls, above a for-profit drug company's financial interests. Consider these facts:

One of the FDA's stated concerns, the impact of over-the-counter availability on minors, is well grounded. A pharmacist in the United Kingdom, where the pills are distributed without a prescription, reported encountering a ten year-old requesting the pills. The pharmacist said, "I found it quite shocking, and she told me she had already used [morning-after pills] 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.

And there are important physical health concerns. During an FDA meeting, the manufacturer, Barr Laboratories, admitted that there were no animal studies of the drugs' effects on adolescents. The chairman of the FDA non-prescription drug committee commented, "it seems to me like the population that we have extremely little information on are the adolescents."

Many FDA panelists raised concerns about informing women of the drugs' abortifacient properties, since they may block the implantation of an embryo in the womb. The chair of the reproductive drug committee and six other members favored putting this mechanism of action on the box, so women who object to abortion would be informed before purchasing the drugs.

One physician noted that the indication for use of the drugs isn't really unprotected intercourse, but rather unprotected intercourse during the window of fertility, which on average is five days out of every cycle. So, most women and young girls who take the drugs will do so "unnecessarily." One doctor emphasized her concern about the "exploitation of young women's fear of becoming pregnant, and that there will be a tendency for this medication to be used over the counter much more and to sell much more than is really needed."

But that's the point, right? Barr would make big profits if a large population of girls and women purchase the drugs out of fear. One financial news website provided estimates that over-the-counter availability of the drugs could bring $25-$100 million in annual revenues for Barr.

Dr. Galson, the acting FDA commissioner who made the final decision on Plan B was present at this hearing. Undoubtedly, the concerns raised by members of his advisory panel made sense to him as they should to anyone. This is not "politics as usual" but the FDA fulfilling its mandate — to put health interests over commercial interests.

Maureen Kramlich is a public policy analyst with the Secretariat for Pro-Life Activities in the United States Conference of Catholic Bishops 

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