Trump and His Impact on the FDA and Clinical Research


Naturally many people in Life Sciences are interested in understanding what Trump’s presidency means for the research industry and the pharmaceutical industry in general. What is so far clear is Trump wants to make the drug development process faster and he thinks there's too much regulation right now. So everyone is speculating what this will mean. As of the date of this article he has yet to appoint a new FDA head.

I interviewed Darshan Kulkarni of Kulkarni Law Firm, and the video interview can be seen in it’s entirety below.  According to Darshan, the way this works is, the FDA is actually a part of the Executive branch. The head of the FDA is appointed by the president, so when the president changes they are allowed to change whoever the previous president appointed and you see this happen all the time. The big thing that happened recently involved the temporary head of the department of justice, Sally Yates. She was fired by Trump, but usually there is a transition team in these instances. Typically, you will have someone who is continuing from the previous administration into the new administration. What happened with Sally Yates was that she did not agree with the immigration ban that took place and got fired as a result of that. Now it’s not particularly unusual for them to fire the heads of particular agencies under the Executive branch. DOJ is one of them and so is the FDA.


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