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.

Trump in general is not a fan of regulations anyways, so how this plays out is going to be interesting. Here’s what the Executive order said: If the FDA is going to put a new regulation in, they have to take 2 regulations out. That sounds like a really good way to do spring cleaning, but the problem with that is you can’t necessarily run a government the same way you do spring cleaning in a house. “It’s not that it’s a bad idea, I just don’t know if anyone has ever even considered doing that”, said Darshan Kulkarni in the below interview. The first question is, who does this even help? Are pharmaceutical companies even asking for less regulation? It really depends where you fall in the industry. If it’s a small organization that does not have significant legal resources, then trying to keep track of the things that they’re responsible for is difficult enough. So for those companies, less regulation would be great. But then let’s take a big company like Pfizer into consideration, a company that has to pay billions in fines for not following certain requirements. To say that the government will stop telling them what to do and keeping them in limbo by not giving them enough information, then that becomes problematic because they need to know the details on what the government deems as necessary. So it’s not fair to say that all pharmaceutical companies want less regulation.

There may be many indirect and direct impacts on the clinical research industry. Technically speaking we’re looking at two kinds of changes: what the Trump Administration will change, and what changes the industry will make in response.

Jerry Stein, PhD, president and owner of Summer Creek Consulting, LLC and vice chair of ACRP’s Editorial Advisory Board, advises that it’s necessary to first take a deep breath for he does not expect to see clinical trial regulations, individual clinical research professionals, or clinical research organizations feel any immediate impact. With very little data it is very difficult to predict what president Donald Trump has in store for the clinical research industry. Paula Smailes an RN, MSN, CCRC, CCRP, a training and optimization analyst for clinical research at The Ohio State University Wexner Medical Center and member of ACRP’s Editorial Advisory Board, states that she cannot recall any mention of research and development funding, not even once during the Presidents campaign.

President Trump made a campaign promise that he will bring manufacturing, such as drug manufacturing, back to the U.S. If this happens,  job opportunities for those in the clinical research industry may increase especially from the logistics and operational business units.. However, President Trump cannot force companies to bring back to the U.S. their company’s manufacturing plants. Instead, the President could impose tariffs on goods/drugs manufactured outside the U.S. by U.S. companies. The effect of such tariff, especially for drugs, is that it will be passed on to consumers and insurers, who will still buy the drugs because they need them regardless of the cost. 

Although, it is a known fact that President Trump has promised to reform the healthcare system, he has said many times that he is against the Affordable Care Act (ACA) Obamacare promising to work with Congress to repeal the Affordable Care Act (ACA) The Obamacare Among the many uncertainties related to the election of Donald Trump is the fate of the National Institutes of Health, the largest public funder of biomedical research in the world. In fiscal year 2016 it had a budget of $32 billion. Trump has promised voters he will cut federal spending, and last year he expressed a negative opinion about the NIH to conservative radio host Michael Savage, saying, I hear so much about the NIH, and it’s terrible. But in response to a question about research from, Trump said that scientific advances “require long-term investment.” Former House Speaker Newt Gingrich, who is a top republican and a Trump’s supporter, could influence the president’s views on the NIH. Gingrich has been a longtime advocate of the NIH and last year appealed to Congress to double the agency’s budget.

 The U.S. National Institutes of Health, located in Bethesda, Maryland, is the largest public funder of biomedical research in the world.

The U.S. National Institutes of Health, located in Bethesda, Maryland, is the largest public funder of biomedical research in the world.

In a statement provided to MIT Technology Review, NIH said it has a long history of bipartisan support and stands ready to work with the new administration to improve people's health and reduce the burden of disease through biomedical research. “Others in the biomedical research community are similarly urging support for medical research. We look at the new administration as needing to understand the real benefits that fundamental scientific research brings to everyone,says Hudson Freeze, president of the Federation of American Societies for Experimental Biology (FASEB), a major industry group that advocates for biomedical research.

Researchers at Boston University and research universities nationally are worried that the new administration will not be supportive of academic research as the previous one, and that there may be significant cut backs.  The researchers at Boston University think that the challenge to the clinical research industry (at least those in academia), right now is due to the fact that the Trump administration has not said much on research and clinical research for that matter. He has less in writing available to us right now, as with my peers at other universities, my job is to get in there early with president Trump's advisors and make the case for funding research and why research is important" says Grodsky, who is being advised on these matters by technology billionaire Peter Thiel, was reported in December by Bloomberg to be considering venture capitalist and Thiel associate Jim O’Neill for the job. Also in the running is Balaji Srinivasan, an engineer and former biotech executive. Unlike previous FDA commissioners, neither O’Neill nor Srinivasan is a doctor or clinical scientist, though O’Neill did serve as an associate deputy director in the Department of Health and Human Services (of which the FDA is part of) during the George W. Bush administration. Both O’Neill and Srinivasan, and Thiel as well, have questioned whether pharmaceutical companies should be required to show that their drugs are safe and effective before selling them to patients.