What do President Trump’s deregulatory executive orders mean for the industry? In this article in Pharmaceutical Online, Catalyst’s Nancy Bradish Myers and Anne Petruska McNickle explore Trump’s “2-for-1” and Task Force executive orders and the accompanying guidance from the Office of Management and Budget’s (OMB), and offer their perspective on implications for FDA and innovators.
For FDA, which issued 27 significant proposed or final regulations in 2016, implementation of the orders will likely require significant time and manpower, and some elements remains up in the air at this point.
Despite some ambiguity that exists for now, “we see this shift in White House policy as an opportunity,” they state. For example, strategic companies, trade associations, and patient groups may seek ways to craft credible cost estimates to share with the FDA and the administration to move policy priorities forward, whether they are withdrawals or advancement of significant regulations.