Advancing Regulatory Science for Public Health

Having read through a lot of articles and researched other topics related to Bioethics in the Medical Industry, I find myself returning to the same question over and over again: am I more a proponent of the advances in the medical field, or am I helping to enhance the dialogue of bioethics and thus hindering the advances of medical technology? What role do I play as a regulatory scientist at work? To answer these questions and adequately reflect on what role I play in this world of bioethics and medical advancements, I turned to an article written by the chief scientists at the FDA called "Advancing Regulatory Science for Public Health." This article can be found at http://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ucm228131.htm. This article discusses the role of the FDA and regulatory bodies in the advancement of medical technologies and public health, but does so in the framework of a regulatory body that limits what companies and scientists can do to promote medical advancement. I struggle with the apparent contradiction that regulatory work furthers the field of medical technology by limiting what it can do. Ultimately I discovered that for advancement to take place, there must be barriers, limitations, and discussions set forth to correctly advance medical technology.

The field of regulatory science is essentially a body of people devoted to evaluating the bioethics of medical technologies. I would have never thought before I started this project that I myself was in the field of bioethics, contributing to the body of work that strives to control, regulate, and caution the advancement of certain medical technologies and practices. At one point in the article I read, the following definition of regulatory science was given: "regulatory science: the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products." Nowhere in the article did it discuss regulatory science as a body who's main goal is to prevent the advancement of medical science. Yes, regulatory scientists question the value of products and practices; yes they question the efficacy of products and practices; yes they question the safety of products and practices, but they do so with the hope that medical advancements can be made in a quick, efficient, and correct matter. This new angle on bioethics helped me to understand what the field is all about. I had been thinking this whole time that bioethicists were all about preventing medical advancements out of some moral reasoning, but now I see that there can be two kinds of bioethicists. One kind tries to prevent advancement out of some moral obligation, and the other kind (the kind I like to think I'm a part of) facilitates medical advancements through tested standards of safety and efficacy. I still don't want certain medical technologies to be created because of health reasons, but overall my position is that of medical advancement in the correct way.

Now the next time a coworker at work is teasing us regulatory people for preventing them from designing and implementing the next big thing, I can argue that our goal is not to prevent, but make sure the design and implementation of the new device is done correctly and as efficiently as possible. People should be thanking us for the work we do, not grumbling about how difficult we make the process. After all, we're keeping them out of prison or from filing for bankruptcy!