RU 486: FDA HAS APPROVED 10 IND APPLICATIONS

RU 486: FDA HAS APPROVED 10 IND APPLICATIONS for research with the Roussel-Uclaf abortifacient RU 486, Solomon Sobel, MD, director of FDA's Division of Metabolism and Endocrine Drug Products, testified Nov. 19 at a House Small Business/Regulation subcommittee hearing. The hearing was called by Rep. Wyden (D-Ore.) to discuss an action imposed by FDA in June 1989 to bar importation of RU 486 for personal purposes. FDA said the ban was imposed to ensure that the compound was not brought into the U.S. surreptitiously for use as an abortifacient without proper medical supervision. Sobel told the subcommittee: "There is no reluctance by the agency to stimulate research" using RU 486. In imposing the ban, FDA was taking a "cautionary position" not meant to halt research, he testified. Sobel said that a researcher had informed FDA that he/she had difficulty in getting RU 486 for studies of Cushing's Syndrome, a sometimes fatal condition caused by an excess of glucocorticoids. Sobel pointed out that the company has contributed to the restraints on research with the drug. "We've had investigators," Sobel said, "who want to bring in the drug [from France] and I can't mention the IND . . . but Roussel-Uclaf has refused to give the drug." In July, the San Francisco Medical Study Group withdrew its IND application from FDA to study RU 486, because it was unable to obtain the drug's master file from the company ("The Pink Sheet" Sept. 24, T&G-10). The protocol involved comparing a combination of RU 486 with progesterone to surgical abortion. Sobel added: "I think we have to keep a line straight on what FDA's contribution is and what Roussel-Uclaf's contribution is." Roussel-Uclaf said that it was not invited to or informed about the hearing. The company stated that it would supply the drug to researchers on the condition that the protocols are acceptable to the company. The subcommittee heard testimony from researchers and patient advocates who said the availability of RU 486 has been limited for purposes of research because of the ban and the reaction of the drug's manufacturer, Roussel-Uclaf. Subcommittee Chairman Wyden asserted that the ban contributed to the "railroading" against American research on RU 486 into such diseases as Cushing's Syndrome and breast cancer. Wyden's staff has been reviewing FDA files on RU 486 since January. He urged FDA to lift the import ban until proof can be gathered that the drug is being misused in the U.S. National Institute of Child Health and Human Development researchers George Chrousos, MD, chief of pediatric endocrinology, and Lynette Neiman, of the developmental endocrinology branch, summarized their research with RU 486. Chrousos' work focuses on new diagnostic procedures and treatments for Cushing's Syndrome, while Neiman's research centers on RU 486's effects on female reproductive conditions. Chrousos testified that he has treated eight Cushing's patients with RU 486. The drug's efficacy was 100% in five of the eight patients. The researcher told Wyden that "we would like to continue our studies of RU 486 into the second phase . . . however, we will not be able to initiate such a study, and accept patients for treatment before we receive an definite commitment from Roussel-Uclaf for adequate supplies of the drug." He noted that the company "has publicly refused to make such a commitment at the present time," but that he had "not had a formal refusal by the company so we don't know, they may finally make it available." Kathryn Horowitz, PhD, a University of Colorado professor of medicine, told the panel that basic research she is conducting on RU 486's effects on breast cancer is "absolutely thwarted" because she can no longer get the drug. She suggested that the ban not only could slow research on other abortifacients, but also have a "chilling effect" on the desire of U.S. drug companies looking into development of similar drugs. Wyden asserted that in response to political pressure from anti-abortionists, the agency moved to limit the drug's supply before there was any evidence that it would be misused in the U.S. Wyden noted that the ban was imposed 19 days after a May 1989 letter from 11 members of Congress led by Sen. Jesse Helms (R-N.C.) was sent to then-FDA Commissioner Young urging the ban. FDA Associate Commissioner of Regulatory Affairs Ronald Chesmore testified that the agency "started drafting this policy many months" before it received the letter from Congress.