- The Washington Times - Saturday, December 2, 2000

Distribution of the controversial abortion pill RU-486 to doctor's offices began last week. The many

media reports about the Food and Drug Administration's September approval of this drug omitted one rather significant detail. Approval of the drug occurred pursuant to "subpart H" of FDA regulations, which allows fast-track clearance of experimental drugs intended for "serious or life threatening illnesses." Accelerated approval means less testing of drugs before they're available. It also means drug companies may be able to avoid strict liability for injuries resulting from their use, since it is understood "there is no assurance of safety" for new and experimental treatments. (This is called "comment k" immunity, and is described in section 402A of the Restatement of Torts, accepted in most states.)

Subpart H was drafted in 1992 as a result of lobbying efforts by AIDS patients, many of whom wanted access to new medications, even if they were experimental. For dying patients, this is understandable, since existing treatment cannot cure them. But how do pregnancy and abortion fit in? Is pregnancy now considered a "life threatening" illness for which chemical abortion is a needed medication?

In short, yes. An FDA office memo to the Population Council, RU-486's sponsor in this country, states that the "FDA has determined that the termination of an unwanted pregnancy is a serious condition within the scope of subpart H." Never mind that pregnancy "termination" is not a "condition."

The FDA abused its own procedures by classifying pregnancy as a "life threatening illness" and then by using an "accelerated approval" process intended for experimental drugs in the treatment of AIDS and other life-threatening illnesses. In addition to being dishonest, this action shortchanges women, since subpart H protects the marketers of RU-486 rather than the women and children who may be injured by its use.

The FDA's action is troubling on a number of fronts. First is the obvious violation of public trust by an agency founded to protect consumer and patient health. Researcher Vivian Orlando, who has written on the FDA's new approval process, repeatedly describes Subpart H drugs to be of "limited safety" or actually responsible for "creating safety hazards." The process bypasses some testing (phase 2 and 3 clinical trials) and reduces opportunities to discover serious side effects or contraindications (health conditions that recommend against a drug's use).

Those dying of cancer or AIDS may well be willing to assume risks from such fast-track clearance. But the woman in an unintended pregnancy probably is not. At the very least, if she is contemplating use of RU-486, she should know it was approved under subpart H, that is, as an experimental drug with unknown risks. She should also know that its makers and sellers cannot be found strictly liable for injuries she sustains from its use.

But nowhere in the many pages of "warning" and "labeling" submitted for RU-486 is this information included.

Second is the FDA's bad faith. According to Vivian Orlando, critics of the new approval process worried about the potential for abuse specifically, that the FDA would expand the number of conditions eligible for subpart H drug approval. (Some even proposed that subpart H be limited to drugs for terminal illness.) The FDA itself assured critics that approval would not be expanded to cover non-serious or non-life-threatening diseases. But now we are supposed to believe pregnancy qualifies.

Is it any wonder the public is cynical about what happens in Washington, D.C.?

One can't help but marvel at the audacity of the abortion lobby and its lackeys in this administration. The approval of RU-486 was extremely big news. Those involved in the process must have known that this abuse of process would be made public. But no matter: They saw a need for accelerated clearance, given a close presidential race and the possibility of a new administration with reservations about abortion-on-demand. What's a little abuse of process to further the cause?

Besides, pro-abortion forces complain they have been waiting years for this drug, though they fail to mention the delay was due to infighting on their side about a patent, and the inability to find a U.S. manufacturer for such a controversial product. Eventually they found a Chinese manufacturer with a record of tainted drug production. This raises even more safety issues, as well as the more obvious problem of the need to collaborate with a country notorious for human rights abuses rather fitting for the making of an abortion pill.

That the FDA is so willing to put women at risk-to the point where it protects drug companies more than an injured woman plaintiff should bother all concerned. It has never been so clear that the interests of the abortion lobby are at odds with the interests of women.



Teresa R. Wagner is an analyst for human rights and life issues at the Family Research Council.

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