This Science Progress article discussed the involvement of the FDA within personalized medicine. We have learned that, with such a new topic and an area of science that is growing exponentially, there needs to be some restrictions and regulations on personalized medicine. The FDA has taken the initiative to create a new position, the Senior Genomics Advisor, whose main focus will be to orientate the FDA to provide scientists and physicians with genetic background information to help create a medicine for patients that will bring individual patient attention and drug dosage. The article states that two main goals need to be met before the US healthcare system can incorporate personalized medicine into everyday use: use of digital medical records and a reformed reimbursement process that rewards positive clinical outcomes. The FDA has also partnered with Medco, a pharmaceutical benefits manager that could supply the FDA with a plethora of knowledge such as de-indentified patients' tests, dosage, and clinical outcomes.
The FDA's focus on personalized medicine is expected, especially because regulation on genetic testing sites is very spotty (as claimed by The Experimental Man author, David Ewing Duncan) and results seem to vary between different genetic testing sites. This article doesn't really focus on the regulating power of the FDA on personalized medicine procedure, but actually a push for this type of medicine to be used in the near future. One tends to wonder if the clinical results will be useful, as there have been problems with ignoring negative clinical outcomes due to a push for pharmaceutical drugs to be placed on the market. I hope that the information used by the Medco-FDA partnership would be used appropriately, and that precautions would be taken if there are any negatives to how individualized dosage is carried out.
In the future, I expect more positions to be created by the FDA as personalized medicine becomes more prominent in the US. For such a fast growing topic, there may be a need for more guidelines and supervision of how records and genetic histories are handled.
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