FDA Panel Moves on RU 486

Recently, an advisory panel to the US Food & Drug Administration recommended the approval of marketing of the French abortion pill, RU 486, in the United States.

Sadly, this predictable, political event bore little relationship to the usual scientific evaluation that we expect from the FDA.

Soon after President Clinton’s inauguration, he announced that one of his goals would be to have RU 486 quickly approved for marketing. The commissioner of the FDA, Dr. David Kessler, announced, contrary to everything that’s ever come out of the FDA, that, when the drug application was submitted, he would see that it would be approved within six months.

The minimum time any life-saving drug has been approved in recent years was 19 months. Typically, other drugs take three to five years. This is not a life-saving drug – it is a life-taking drug.

From the beginning, the advisory panel was stacked with abortion-supporters. Life Issues Institute and 10 other leading national pro-life, pro-family organizations addressed this issue with the FDA in a letter requesting that six of the people on the panel be removed, complete with documentation.

In an unusually rapid reply one week later, the FDA denied that there was any conflict of interest and stated that these people’s previous activities would have no bearing on their judgment. However, three of the six did not participate, likely because of our letter.
There were three that did: The panel chairman, Dr. Ezra Davidson, had signed on to a full-page ad in the Washington Post defending unrestricted abortion and opposing any legislation restricting it. He was a member of the steering committee of Physicians for Choice of Planned Parenthood.

Dr. Diana Petitti also had a public pro-abortion track record.

Dr. Philip Corfman, executive secretary of the panel, was responsible for overseeing the planning and conduct of the hearing. He has been an employee of Planned Parenthood, and was a founding member of a leading pro-RU 486 lobbying organization, the Reproductive Health Technology Project.

The panel reviewed data from two French clinical trials that reported on a total of 2,500 women. It also accepted preliminary results from more recent American trials involving 2,100 women. The American data were preliminary, and have not been thoroughly reviewed nor verified. One of the members of the panel, Dr. Mary Jo O’Sullivan, Professor and Director of Obstetrics at the University of Miami School of Medicine, publicly stated, “I don’t know why this meeting is being held at this time when the data are not finalized.” She pointed to the fact that this has never happened before – that the final data were not due for at least another six months, and that to accept preliminary data on such a controversial drug was unheard-of.

The final approval by the FDA does not have to follow the advisory panel’s recommendations. However, it usually does.

Of the eight members of the panel, the final vote was seven in favor, with one abstention. An earlier vote had been six to two to affirm that the French studies had established the efficacy of using RU 486. A third vote, six to two, stated that the benefits outweighed the risks.

Panel member Dr. O’Sullivan, when discussing the risk/benefit ratio, pointedly asked, “Benefit to whom? If you’re talking about the woman, it may be beneficial to her, but it’s of no benefit to the baby whatsoever.”

Another disturbing issue was who should not take the pill. In France the pill cannot be given to those who smoked 10 or more cigarettes a day, had heart and circulation problems, asthma, glaucoma, diabetes, high blood pressure, kidney, liver or adrenal problems, anemia, and if they were over age 35. No recommendation was voted on by this panel as to whether women with such health problems would be excluded in the United States if this drug were licensed.

Another disturbing fact was that the US tests did not examine women 18 and under. The recommended approval does not exclude its use for women 18 and under, further evidence of the unscientific approach that is being taken in licensing this drug.
One of the few good things that came out of the hearing is that advocates of RU 486 wanted approval for use up to nine weeks, or 63 days, after the first day of her last normal menstrual period. The panel, however, recommended that it only be used from 5 to 7 weeks. This means that if she comes in when she is one week overdue for her missed period, the pill can only be used in those next two weeks.

And who would administer it? The panel merely stated that the abortionist who uses the RU 486/Cytotec combination must be able to diagnose and date pregnancy, identify a tubal pregnancy, have ultra-sound available and be able to do an emergency D&C to stop hemorrhage or to complete the abortion. Any doctor with a license to practice medicine could qualify under these recommendations.

Very disturbing was their recommendation that RU 486 must be administered “under the supervision of a physician”. It did not say “given by a physician”. This means that a nurse or physician assistant, rather than a doctor, may be the only person the aborted woman sees.

In short, this panel relied upon the experience of France which has a far more rigid and controlled patient population than the US. The testing that they relied on from France is not comparable to the medical practice in the US.

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