"RU-486" - It's Worse Than You Think

The most recent issue of Life Insight covered developments concerning mifepristone ("RU 486") prior to its final approval by the Food and Drug Administration (FDA) on September 28. As it turns out, the final guidelines are even worse than anticipated. Relaxing significantly the relatively modest safety standards reportedly proposed as recently as June 2000, they represent an almost total capitulation to the abortion lobby.

In discussing the troubling aspects of mifepristone/ misoprostol ("M/M") approval, one suffers an embarrass de richesses—possible procedural irregularities in the FDA actions, manufacturer concerns and the drugs' inherent dangers.

Has the FDA Violated Its Own Regulations in Rushing M/M to Market?

Lawyers looking into the mifepristone/misoprostol approval have raised a question whether the FDA has misused its regulatory authority. The approval letter states: "The application is approved under 21 CFR 314 Subpart H." This subpart, entitled "Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses," was promulgated in 1992, in response to criticism that the FDA was too slow in approving experimental drugs to combat HIV/AIDS. It allows patients with very severe or terminal illnesses to obtain experimental drugs and antibiotics even before their safety and efficacy are fully explored. Expedited processing and approval under Subpart H are limited as follows:

"This subpart applies to certain new drug products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments (e.g., ability to treat patients unresponsive to, or intolerant of, available therapy, or improved patient response over available therapy)" (21 CFR §314.500; emphasis added).

Every drug approved under Subpart H prior to July 2000 is conveniently listed on the FDA website at http://www.fda.gov/cder/rdmt/accapp.htm. About a third of the 28 listed drugs combat HIV, another 7 deal with specific types of cancer. One governs the use of thalidomide in treating leprosy. All apparently relate to the treatment of life-threatening illnesses.

The FDA's reliance on Subpart H to expedite approval of two extremely risky drugs for abortion seems a mockery of the regulatory purpose. Pregnancy is not an illness and certainly not one that is life-threatening in the first seven weeks (unless it is a tubal pregnancy in which case M/M abortions are absolutely contraindicated). Other "safe" methods of abortion are readily available. There is no medical urgency in approving the drug combination before completing customary studies; the only urgency is dictated by the approaching end of the current Administration which has fought so long and hard for approval.