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REP. WYDEN INVESTIGATING RU 486 HANDLING BY FDA

Executive Summary

REP. WYDEN INVESTIGATING RU 486 HANDLING BY FDA, the Oregon Democrat said at a Sept. 18 breakfast meeting with the press. "Since January, I've had my staff going into the files at FDA." Wyden said. "What I'm interested in with respect to RU 486 is one thing, and that's that it is treated as a drug, with the notion that the government is going to determine whether or not it's safe, and not play politics with it." He added: "The answers I've gotten from FDA in the written responses to questions, plus our review of the files leads me to think" the agency would consider factors other than "whether or not its safe." The abortifacient drug, which has drawn strong opposition from anti-abortion groups, is marketed in France by Roussel-Uclaf. The company's U.S. affiliate, Hoechst-Roussel, has not sought regulatory approval to test or market the drug in this country. The San Francisco Medical Study Group said it submitted an IND to FDA in June but withdrew the application in July. The group said it needed Roussel-Uclaf's entire master file on the drug and has been unable to obtain it from the company. The San Francisco Medical Study Group also submitted a research protocol for RU 486 to the University of California/San Francisco's Institutional Review Board earlier this year. The protocol would cover a study comparing RU 486 combined with progesterone to surgical abortion in early stage pregnancy. Wyden hinted at the possibility of future congressional hearings on RU 486. However, he said he did not "have anything to announce" yet on the issue. "One of the things that we're thinking about is a hearing" before the Congress, Wyden said. He suggested that "there is some real benefit in having officials from the Administration, the FDA and the NIH [National Institutes of Health] come on up and testify to the United States Congress in sworn testimony that [safety and efficacy are] the basis they'll make a decision on" regarding RU 486. In April, 14 California representatives in Congress wrote to President Bush enlisting his cooperation to ensure that any application to FDA be given "fair review based on its scientific merits." They also noted that FDA "will not permit personal importation of RU 486 although it is allowed for other unapproved drugs." Wyden said his review indicates that FDA's position against importation is not backed up by any written documentation of its justification. The Oregon congressman also noted that the drug has other potential therapeutic applications, including breast cancer and Cushing's disease, a condition usually seen in women that involves excess production of cortisone. An editorial in the Aug. 22/29 issue of The Journal of The American Medical Association noted that the "threat of boycott by antiabortion advocates is blocking or delaying the availability of RU 486 (mifepristone) as a drug of proven or potential value in Cushing's disease, meningioma and breast cancer." The editorial writers recommended that RU 486 "be made available for study in the 'crisis constituency,' those patients with limited life expectancy or serious compromise of quality of life whose medical needs have nothing to do with abortion or contraception." Wyden was also asked about his effort to develop legislation to tighten regulation of cosmetics. "We're going forward with it," he said. The proposal is expected to address premarket testing for cosmetic products and ingredients, FDA access to safety and adverse reaction data, and regulation of cosmetics with drug-like features, dubbed "cosmeceuticals." "My own sense is that we're moving toward a period of time when the Food, Drug & Cosmetics statute has got to be rewritten," Wyden continued. "We've got a statute out of the '30s; we're in the '90s. The whole drug industry has changed very dramatically. I have been looking in a number of areas. I'm doing an investigation now into the way FDA is handling RU 486, I'm looking at the question of cosmeceuticals. My sense is that the Food Drug & Cosmetics statute has not kept up with the times."
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