-
eac25 started the topic Potential FDA Changes under Trump in the forum Introduction to Project Management 8 years, 2 months ago
This concerns information we covered past in week 2 but I feel like this is a pretty relevant topic.
Based on a recent executive order that Trump has made, it seems that Trump is trying to cut the amount of FDA regulations. The executive order itself amounts to a “one in, two out” policy where an agency will have to identify two regulations to be repealed before instating a new one. This by itself seems pretty unimpactful but at a recent White House meeting, Trump stated, “We’re going to get the approval process much faster,” and, “one thing that’s always disturbed me is that you come up with a new drug for a patient that’s terminal and FDA says you can’t have this drug used on this patient and patient will be dead… we don’t know if drug works or doesn’t work, but the patient’s not going to live for more than 4 weeks.”
I’d like to avoid purely political discussion and focus more on the possible ramifications of an FDA that has much less regulations. Do you think cutting regulations would result in more terminal patients being saved?I’ll also try to keep this thread updated with future news seeing as Trump has yet to appoint a new FDA Commissioner. One of his supposed choices, Jim O’Neill, was said to favor a “post-marketing approval” mindset, where instead of being required to show both safety and efficacy before marketing as it currently is, a company would instead have to show just safety first, with efficacy shown later. What may be some pros and cons to a system like that?
Sources:
https://www.whitehouse.gov/the-press-office/2017/01/30/presidential-executive-order-reducing-regulation-and-controlling
http://www.raps.org/Regulatory-Focus/News/2017/02/01/26751/Trump-Pledges-to-Gut-FDA-Which-Regulations-Need-to-Go/
https://www.bloomberg.com/politics/articles/2017-01-31/trump-meets-with-drugmakers-as-industry-fears-price-controls
http://www.natlawreview.com/article/how-will-trump-change-fda