TREATMENT IND "COOKBOOK" IS UNDER DEVELOPMENT, FDAer LEVITT TELLS PRENTICE HALL SEMINAR; COM. YOUNG TRACKING IMPORTANT NDAs VIA COMPUTER PROGRAM

FDA is developing a "cookbook" for Treatment IND filing procedures in order to help explain "more of what the process is about," Office of Executive Operations Director Joseph Levitt reported at a Prentice Hall Law & Business seminar, Nov. 17 in Washington, D.C. The agency's decision to develop such a guidance may have been influenced by suggestions made in February at an FDA/American Medical Association seminar on Treatment INDs. At the meeting, D.C. attorney Peter Hutt (Covington & Burling) observed a need for further information on the Treatment IND process, including "a cookbook type of direction" and a list of IND drugs for treatment use, emergency use and compassionate use ("The Pink Sheet" Feb. 22, T&G-2). The Treatment IND "cookbook" is indicative of the proactive approach being taken by FDA to encourage Treatment IND submissions. FDA Commissioner Young said at the meeting that he is setting up a computer program that will list those drugs in which he is interested, and will identify where they are in the agency and who is reviewing them. "I will follow them very carefully, and I will follow them in your shops as well," Young told the seminar participants. Noting that he is "not at all shy at calling up CEOs and asking for things," Young related one recent incident when he called a company on a Monday for labeling information and demanded a response by the following Friday. The lack of information on how to go about obtaining Treatment IND status of drugs is apparently only one of the reasons why industry has not taken full advantage of the procedure. Bristol-Myers Pharmaceutical Division VP-Worldwide Regulatory Affairs George Ohye described another as "fear of the unknown." He observed that "managements of the various pharmaceutical companies are concerned that the Treatment IND may slow down the approval process." Companies see FDA taking the view of why rush approval of an NDA when the drug is already available, he said. Ohye said that his personal view is that Treatment INDs are beneficial. "I think that if your drug is accepted for a Treatment IND it means an important milestone has been passed, that there is sufficient evidence that the drug is safe and effective." He noted that when a drug has Treatment IND status, a sense of urgency with respect to the NDA is created. In addition, the granting of a Treatment IND presents a publicity opportunity for the drug and the company. Industry's perception that a Treatment IND compromises the company's ability to recruit patients for controlled trials was discussed during Q&A. Ohye responded that Treatment INDs are not granted "unless there is a significant body of evidence to show that the drug is working, so that presupposes that you have the appropriate trials under way." FDA Office of Drug Evaluation I Robert Temple noted that for two drugs, Somerset's Eldepryl (selegiline) and Ciba-Geigy's Anafranil (clomipramine), all the clinical work was completed prior to the granting of the Treatment INDs. However, he acknowledged the inherent difficulty when ongoing trials are broken. "I think commercial sponsors are very cautious about doing that because they are afraid it will interfere with the trials," Temple said. One way to avoid the problem, Temple suggested, is for sponsors to provide a drug under a Treatment IND for severely ill patients and conduct clinical trials with another category of patients. He noted that trials are currently ongoing for deoxycoformycin (Warner-Lambert's Pentostatin), which received "initial" Treatment IND status in July for treatment of refractory hairy cell leukemia ("The Pink Sheet" Aug. 8, T&G-1). Deoxycoformycin is in Phase III study at the National Cancer Institute.