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Executive Summary

TREATMENT IND DRUG LIST SHOULD BE MADE AVAILABLE along with procedures for obtaining the unapproved products, Washington, D.C. lawyer Peter Hutt (Covington & Burling) maintained at a Feb. 16 seminar sponsored by FDA and the American Medical Association (AMA). "We need some very hardcore, practical information," Hutt said, "and I would propose four concrete steps": A "lead article in JAMA [the Journal of the AMA] that explains all this nonsense in ordinary English," a how-to, "cookbook type of directions," An FDA pamphlet to explain how to obtain an IND, "A list of IND drugs for compassionate use, emergency use, treatment use," and other uses for which experimental drugs may be obtained, "Finally, designation of a single person or single office in FDA that people can call . . . to get some real answers." FDA Commissioner Young asked Hutt how FDA could release information about the progress of a sponsor's proprietary IND. "Would your clients object, or is it truly possible for FDA to give its impression of what the status is based on its knowledge of IND investigations?" Young inquired. Although many INDs "remain trade secrets and their existence is not known and is kept confidential" by FDA, Hutt replied, others are made public through Securities & Exchange Commission filings and press reports. "With regard to the vast majority which are known, I think it's entirely possible that FDA could have a list, on a voluntary basis, from the companies," Hutt said. Such a list would include the companies' "view of the status" of the INDs "in terms of whether an open label study is being conducted that a physician could tie into, whether a compassionate use is available, whether a treatment protocol has been filed, whether a Treatment IND has been filed by another [independent] physician, or whether one of these other categories applies." Obviously, he added, "you couldn't force [a sponsor] onto that list, but you could make it voluntarily available," and the physician and patient populations "would find it enormously useful." Hutt asserted there are three "practical problems" with the Treatment IND regulations. First, noting that FDA distinguishes between Treatment INDs, commercial INDs, individual investigator INDs, emergency INDs, and compassionate INDs, Hutt said "there is confusion about the different types of INDs that are available." Second, "there is uncertainty how anybody in the world, any doctor or any patient, can go about getting a Treatment IND or any of those other fancy INDs," he said. "Third, there is a lack of information about what drugs are actually out there and available" and how to obtain them. At the close of the meeting, FDA Center for Drug Evaluation and Research Director Carl Peck, MD, commented that the one message clearly conveyed at the conference was the need for additional information sharing. He noted that the agency publishes a monthly list of publically disclosable AIDS drugs under investigation, and that FDA would look into making information about Treatment INDs more accessible.

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