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RU-486: FDA Hesitates Once More. Why the Delay?

ve8QAd   |   April 01, 2000

Three months ago we had what seemed final notification that the US Food and Drug Administration (FDA) would be approving the French abortion pill, RU 486. Now we are told that there may be another delay of 6 months or more. Two reasons have been given, but not elaborated on. One mentioned is the manufacturer, while the other mentions labeling. Let’s look at these two.

It has long been routine, standard policy, when preparing to approve any drug, that the FDA has investigated the pharmaceutical manufacturer. They go to the factory and inspect the entire process of purification, manufacturing, packaging, etc. This, of course, is a logical and necessary thing to do. We certainly wouldn’t want to be taking drugs that came from, e.g., an unsanitary or inadequate operation. So here’s the problem. In order to facilitate an inspection, the company will have to give the address of its production facility. At this point, all that has been made public is Danco, the name of the company. But when the address of the production facility is made public, rest assured there will be protesters on the sidewalk, and the pro-life movement will instantly publicize this location. Could it be that this failure to disclose is because such disclosure might reveal some type of vulnerability to pro-life pressure? It seems like a logical reason.

The second reason mentioned, and without any explanation, is that the FDA has merely stated there are problems with labeling. This one looks clearer. As our readers know, there are two drugs involved in the RU 486 abortion. One of them is the drug itself. The company can and will propose the labeling to be used. The Food and Drug Administration will critique or possibly suggest some modification, and the Danco Pharmaceutical Company then will be free to accept or reject any suggested changes for RU 486. We see little reason for a delay here.

The problem is with the second drug used – Cytotec. G.D. Searle manufactures this drug, and it has been on the market for over a decade. Its labeling, created by G.D. Searle, is very clear. It notes that the drug is to be used to protect the stomach from damage caused by anti-arthritic drugs. It also clearly states that this drug is contraindicated in pregnant women. Searle has been asked, on a number of occasions, to change that labeling and has consistently refused. Assuming that remains its position, this offers a major problem for the FDA. Can it recommend the use of this drug for a purpose which the drug’s owner publicly objects to? If Searle did agree to change the labeling so as to permit it to be used during pregnancy and, of course, to end a pregnancy, then it would lay itself open to legal liability for any complications that may occur to the pregnant woman or to her post-born child that can be traced back to the use of Searle’s drug. We assume that Searle does not want to take this medical, legal risk and so does not want to change the label. The impasse, then, is whether the FDA can approve its use in such a situation. Who will the woman sue if she is injured by the drug? Not Searle. Would she sue the FDA?

Let’s hope they don’t find an answer to the two reasons mentioned why the most recent delay has occurred. If the FDA approval is delayed long enough, and then we have the good fortune to elect a pro-life president who takes office in January, perhaps RU 486 will never be licensed. Tens of thousands of innocent unborn babies would strongly agree.

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