Trump Effect on FDA Regulated Industry
​[Posted on: Thursday, November 10, 2016]

In an obligatory article on the shocking presidential election results, let’s discuss the expected affect of the political upheaval on the pharma industry. It is purely speculative as nobody can say with authority what President Trump would do. The politics of the time does affect the regulatory environment. The good things first. Last eight years have seen some major developments at FDA to speed up drug approvals and incentivize innovation. It should not get affected much as the Republican administration is likely going to be industry-friendly and will not reduce the good things for the industry. So, if you are worried about changes to the breakthrough designation, the priority review vouchers, and precision medicine, you can breathe easy; those programs are here to stay. Similarly, you should not expect much change to most of the review processes, applications, interactions with the reviewers, and public presentations by FDA. Some controversial areas of research are probably going to get in trouble. Embryonic stem cell work should see the same negative impact as the Bush administration. Drug pricing control initiatives is most likely going to get shelved. Last two years had seen major campaigns to control the drug prices; it was expected that price control measures may be introduced soon but with all three branches of the government and the Supreme Court to be in conservative control, all of which do not support price control, drug price control is likely not happening anytime soon. Healthcare overhaul was one of the biggest issues of this election and we should expect major changes linked primarily to repealing Obamacare. Overall, the regulatory processes governing the FDA-regulated industry should not see much change but the business aspects are expected to change substantially. So, for us regulatory experts and drug developers, it should be good times financially.