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TIL GENE MARKER IND DID NOT REQUIRE NIH COMMITTEE REVIEW, FDA

Executive Summary

TIL GENE MARKER IND DID NOT REQUIRE NIH COMMITTEE REVIEW, FDA Commissioner Frank Young suggested at the Human Genome Conference in Washington, D.C. April 24. "When the French Anderson experiment came forward, it did not have to go to the NIH committees at all for review," Young said. "The only requirement for introduction of genes into mankind is the review and action by the FDA." The IND for the gene-marked Tumor Infiltrating Lymphocyte (TIL) was submitted to FDA in October 1988 by National Heart, Lung and Blood Institute Chief of Molecular Hematology W. French Anderson, MD, and National Cancer Institute Chief of Surgery Steven Rosenberg, MD. By the time of submission of the IND to FDA, the protocol for use of the gene-marked cancer agent had been reviewed by six National Institutes of Health committees. Young also discussed the implications for drug discovery of the Human Genome Project, which is scheduled to be completed in 15 years. "We will have the capacity within probably the next decade to begin to design drugs that will be specifically fitted for subpopulations," Young predicted. The commissioner pointed out that resulting therapies may test the boundaries of orphan exclusivity: "As we know more about the genome," Young asked, "are diseases that were once thought to be very rare within the population and found now to increase those that we should break this exclusivity for?" Noting a movement afoot in Congress, led by Sens. Kennedy (D-Mass.) and Hatch (R-Utah), to place greater controls on the products that qualify for orphan exclusivity, Young cautioned that "breaking exclusivity should not be done casually or not granting it should not be done casually." In a separate presentation to the conference, Johnson & Johnson Corporate Director for Advanced Technology Jack McConnell suggested that a consortium of human genome research coordinated by a national advisory panel should be established. McConnell, co-inventor and developer of the Tine test for tuberculosis, explained that the consortium would, among other things, "develop a strategy for mapping and sequencing the human genome, ensure the quality of scientific work, ensure that we are proceeding on a timely and cost effective basis, and manage international cooperative relationships." McConnell argued that the consortium would foster public sharing of technological advances and guard against competitiveness within the national effort. The national advisory panel would include the secretary of the Department of Energy, the directors of NIH, the National Library of Medicine and the National Science Foundation, and four genome experts each from private industry, academia and national labs. NIH will soon begin work on a comprehensive planning program for the human genome project with the Department of Energy, NIH Office of Human Genome Research Director Elke Jordan, announced at the conference. NIH's human genome advisory committee has been mandated to issue a report on the plan by early 1990, and will establish a working group for the report at its June meeting.
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