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Agnieszka replied to the topic Potential FDA Changes under Trump in the forum Introduction to Project Management 8 years, 2 months ago
This is a really great topic because it is relevant and controversial. My thoughts are these: Trump has the right intent, there are problems within the regulatory practices/policies of the FDA and we need a concrete, forthright solution. However, his idea for a solution, deregulating the FDA/loosening the reins on their approval processes, is dangerous.
Firstly, removing efficacy as a requirement means not being concerning with whether the product will do what it was designed to do. Also, it would seem that any side effects (especially medically concerning ones), as long as they pass safety requirements, would not be a great concern. If a cancer drug causes your eyes to become overtly sensitive to light and your spit becomes radioactive, this would not matter as long as it is killing the cancer. This lax mindset might also impede the desire to improve on any existing product.
Secondly, not being concerned with the welfare of terminally sick patients echos the medical experiments run by Nazi doctors during WW II. Even though they are terminally ill, should they be subjected to the pain and/or serious after effects of an uncertain drug? (This is more of an ethics question). This is what happens when doctors take it upon themselves to determine the public health care system of their nation, they forget about the individual patient.
Thirdly, in their role, the FDA keeps a check on the integrity/honesty of the companies, manufacturers, and people that create new drugs. They make sure no one is cutting corners for a quick profit. Therefore a deregulated FDA would then rely on these organizations as well as doctors and engineers to do the regulating. This is especially dangerous in a capitalist country where businesses are always relentlessly competing with one another to stay alive.