FDA+and+NIH+Guidelines

FDA and NIH Guidelines for Research
 * The current guidelines have stemmed as responses to two of the therapy trials we have already discussed:
 * INDENT: The case of Jesse Gelsinger.
 * INDENT: French gene therapy leukemia case.


 * REFERENCE: http://www.ornl.gov/sci/techresources/Human_Genome/medicine/genetherapy.shtml

__Gene Therapy Legislation in the U.S. __ Both the National Institute of Health and the Food and Drug Administration serve to protect Americans by regulating the use of gene therapy.

NIH and the RAC – · The National Institute of Health established the Recombinant DNA Advisory Committee (RAC) on October 7, 1974. · The main job of the RAC is the review of human gene transfer research. They analyze all of the studies involving recombinant DNA technology and then report back to the NIH about their findings and give recommendations for legislation regarding the technology. All human gene therapy trials that take place at institutions which receive federal funding from the NIH are reviewed by the Recombinant DNA Advisory Committee.

FDA & CBER – · The U.S. Food and Drug Administration is a U.S. government agency put in place to protect the health of our citizens by making sure that drugs, medicine and other products are safe and effective before they are put in use. · The FDA’s Center for Biologics Evaluation and Research (CBER) regulates human gene therapy because if falls under the legal definition of a “biologic," which is a biological product, like a vaccine, used in medicine.

__CBER Requirements for Gene Therapy Research __
 * Manufacturers of gene therapy products must go through extensive tests and meet requirements put out by the FDA before they can even test a product in a lab.
 * If lab results are successful, they can test the gene therapy treatment on animals.
 * <span style="font-family: Tahoma,Geneva,sans-serif; font-size: 120%;">At this point, they must receive a special exemption, an Investigational New Drug Application (IND), from the FDA in order to test their product on humans.
 * <span style="font-family: Tahoma,Geneva,sans-serif; font-size: 120%;">They also must get approval from an institutional review board, which is a committee of advisors, specializing in science and medicine, and consumers.
 * <span style="font-family: Tahoma,Geneva,sans-serif; font-size: 120%;">In addition, the researchers conducting the study must receive consent from participants, informing them of potential risks and benefits.

<span style="font-family: Tahoma,Geneva,sans-serif; font-size: 120%;"> SOURCE: <span style="font-family: Tahoma,Geneva,sans-serif; font-size: 120%;">Bleijs, D.A., comp. Gene Therapy Legislation in the United States of America. Issue brief. Gene Therapy Net, 2010. Web. 1 Dec. 2010. <http://www.genetherapynet.com/united-states-of-america.html>.

__<span style="font-family: Tahoma,Geneva,sans-serif; font-size: 120%;">Gene Therapy Legislation Around the World __ <span style="font-family: Tahoma,Geneva,sans-serif; font-size: 120%;">China – <span style="font-family: Tahoma,Geneva,sans-serif; font-size: 120%;">China is the first country to release commercial gene therapy drugs.

<span style="font-family: Tahoma,Geneva,sans-serif; font-size: 120%;"> SOURCE: <span style="font-family: Tahoma,Geneva,sans-serif; font-size: 120%;"> Bleijs, D.A., comp. Gene Therapy Legislation in China. Issue brief. Gene Therapy Net, 2010. Web. 1 Dec. 2010. <http://www.genetherapynet.com/asia/china.html>.

<span style="font-family: Tahoma,Geneva,sans-serif; font-size: 120%;">Europe – <span style="font-family: Tahoma,Geneva,sans-serif; font-size: 120%;">· There are many discrepancies regarding to legislation across Europe and scientists are calling for a ‘best practice philosophy’ across the European Union.

<span style="font-family: Tahoma,Geneva,sans-serif; font-size: 120%;">SOURCE:

<span style="font-family: Tahoma,Geneva,sans-serif; font-size: 120%;">John Illman. Gene Therapy in Europe: New Initiatives Seek Streamlined Debate. J Natl Cancer Inst 2000 92: 188-190. <span style="font-family: Tahoma,Geneva,sans-serif; font-size: 120%;">[]