FDA and Gene Therapy Term Paper

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Gene Therapy

FDA

Ethics can be considered to come from personal values. From both a medical and a business perspective, ethics are the reasons that some news stories should be followed from beginning to end and all in between. "On Sunday morning, 23 February 1997, the world awoke to a technological advance that shook the foundations of biology and philosophy. On that day, we were introduced to Dolly, a 6-month-old lamb that had been cloned directly from a single cell taken from the breast tissue of an adult donor." (Brannigan 10) This report is not about cloning per se, but it is about the underlying industry for gene therapy and the Food and Drug Administration regulations as they pertain. The secondary goal is to point out who controls the legal aspects of a new drug application process. Like cloning, gene therapy is in some circles a great medical and scientific breakthrough while in other circles it is the be all and end all of the human race. That is why it is wise to understand not just the technology, but it is also prudent to see who regulates any new technology like gene therapy.

"Since the issuance of the "Points to Consider (PTC) in Human Somatic Cell Therapy and Gene Therapy" in 1991, the range of gene therapy proposals has expanded to include additional classes of vectors and use of vectors in vivo via direct vector administration to patients.

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This guidance document updates and replaces the 1991 PTC with new information intended to provide manufacturers with current information regarding regulatory concerns for production, quality control testing, and administration of recombinant vectors for gene therapy; and of preclinical testing of both cellular therapies and vectors. These guidance's are not regulations, but rather represent issues that the Center for Biologics Evaluation and Research (CBER) staff believes should be considered at this time." (Murphy)

Gene therapy is a surprisingly simply process where genes are manually inserted into an individual's cells and tissues with the intention of treating any inherent diseases. The methodology shows promise in several areas but currently has seen more success in the treatment of known hereditary diseases. Current research has both the business and governmental sectors vying for breakthroughs in areas like cancer, cystic fibrosis, heart disease, hemophilia, wounds, infectious diseases such as AIDS, and graft-versus-host disease. This is a relatively new industry and the growth potential is very high. The key with gene therapy is that new discoveries are made not annually but daily. This process has already made its way into the daily options of mainstream medicine for physicians dealing with certain viable diseases and conditions. There are some who still feel that the….....

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