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Executive Summary

The Department of Health and Human Services would encourage Treatment INDs for AIDS therapies through public notices of the potential usefulness of experimental drugs in AIDS patients under an amendment prepared by Rep. Waxman (D-Calif.) for his AIDS bill (HR 5142). Waxman's amendment was agreed to by the full House on Sept. 22, and the bill passed the House by a vote of 367-13 Sept. 23. The amendment is designed to encourage Treatment IND distribution of experimental AIDS drugs by using Federal Register notices to identify potential therapies for IND testing, to encourage IND sponsors to submit Treatment IND applications, and to encourage others to submit Treatment IND applications if the original sponsor does not. The amendment responds to the concern that FDA is not receiving a sufficient number of Treatment IND applications for AIDS drugs. During recent congressional hearings, FDA Commissioner Young has testified that Treatment IND applications have not been filed for all potential AIDS drugs. The agency "cannot, regretfully, approve something that we do not have the applications for," he said ("The Pink Sheet" July 18, p. 10). The amendment provides that after IND is granted for the testing of a potential AIDS therapy, HHS will "encourage the sponsor of the new drug to submit to the secretary . . . an application to use the drug in the treatment of individuals (i) who are infected with the etiological agent for AIDS; and (ii) who are not participating in the clinical trials conducted" under the IND. If Treatment IND use is approved, the amendment continues, HHS will "encourage, as appropriate, licensed medical practitioners to obtain . . . the new drug from such sponsors for the purpose of treating such individuals." The amendment further directs HHS to seek Treatment IND applications from medical practitioners if the firm sponsoring the IND does not apply for one. "If the sponsor of [an IND] does not submit to the secretary an application" for Treatment IND distribution, the amendment states, HHS "shall, through statements published in the Federal Register," encourage, as appropriate, licensed medical practitioners to submit to the secretary such applications." HHS will help identify potential AIDS drugs for IND sponsors, under the amendment. "If, in the determination of [HHS], a new drug has potential effectiveness with respect to the prevention or treatment of AIDS, the secretary shall," by notice in the Federal Register, "A) announce the fact of such determination; and B) with respect to the new drug involved, encourage [IND] applications for an exemption for investigational use of the new drug." The amendment adds that recommendations for appropriate drugs would be made by the AIDS Clinical Research Review Committee established by HR 5142. It also authorizes FDA to give "technical assistance" either "directly or through grants or contracts" to parties applying for INDs or Treatment INDs, or trying to obtain experimental drugs for use under approved Treatment INDs. Another amendment adopted on the House floor Sept. 22, offered by Rep. Madigan (R-Ill.), replaces provisions for staffing of the Public Health Service with a more general requirement that 780 new positions be added, without specific quantitative allotments of new personnel to specific Public Health Service agencies; and also requires that the requirement for expanded staffing expire on Oct. 1, 1989. Previously, the bill had provided FDA with an additional 50 staffers to work on AIDS-specific research activities ("The Pink Sheet" Sept. 12, p. 4).

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