Why You Should Get Behind Scott Gottlieb and the FDA – Whether You’re a Trump Supporter or Not

The recent shutdown is reminding us all (not that we need to be reminded) of ongoing political division and partisan bitterness. In these heated times, there is an unfortunate tendency to dismiss anything or anyone associated with an opponent as being bad or wrong. In all the back-and-forth political bluster, opponents and supporters of the Trump administration alike often lose sight of positive developments that call for common recognition. The sea of change at the Food and Drug Administration (FDA) led by Scott Gottlieb is an example of good things happening under the polarized surface, and we need to make sure we do not let partisanship derail this progress.

As with other administration figures, Gottlieb has been criticized for allegedly pursuing the president’s “deregulatory” agenda at the expense of public safety and health. A New York Times editorial last year criticized what it regarded as increasingly lax standards (i.e., shortening the time required) for drug approval by the FDA, arguing “Lest it [the FDA] lose … standing, the agency should demand more of the drugs … it approves.” It is difficult to disagree with that point in principle, but does it really necessitate longer approval times?

The problem with the well-meaning Times editorial is that it confuses regulation itself with a positive impact, and (perhaps unconsciously) views this issue through the political lens of Trump’s deregulatory push rather than through the latest trends in medical science. Specifically, breakthroughs in detecting signs of disease through protein biomarkers – biologically relevant indicators of disease found in blood, tissue or bodily fluids – have progressed rapidly. The FDA recently authorized the first blood test to evaluate concussions– the first blood test ever approved for any brain biomarker. This marks an innovative and monumental approach to disease monitoring and prevention that is also having an impact on the drug approval process. Recent advances in utilizing biomarkers are speeding up the process of determining whether or not drugs are effective.

A great case in point is the recent statement by Commissioner Gottlieb announcing the FDA is issuing guidance on using the biomarker Minimum Residual Disease (MRD) in clinical trials of drugs to treat certain blood cancers. MRD are remaining cancer cells found in a person’s body during or after treatment and are cause of relapse. Detecting them during or after treatment can determine whether a drug has been effective long before full-blown cancer reappears. What this means for some cancer patients is that instead of having to “wait and see” if a treatment worked, and then having to undergo a different treatment after the disease returned, they will know earlier if they need to switch to a different drug. In clinical trials for new drugs, it means the approval process can be shortened and fewer tests need to be carried out, leading to new drugs getting to market and saving lives faster. Anyone who has suffered from cancer or lost a loved one to it should understand the significance of these developments and the FDA’s embrace of MRD as a potential game changer.

MRD is just one biomarker that could streamline and shorten drug approval. The evidence is mounting that another biomarker, neurofilament light chain (NfL), can be accurately used to measure both disease activity and responsiveness to drug treatment in people who suffer from multiple sclerosis (MS). Actress Selma Blair’s recent diagnosis with MS has put this disease into the public spotlight. Given that it takes months or longer before the efficacy of a particular drug treatment for MS can be measured using the conventional approach of an MRI, MS is the ideal candidate for a drug treatment process that utilizes blood-based biomarkers, which can quickly and cost-effectively measure disease activity and whether the therapeutic agent is in fact working. MRD and NfL are two examples of how biomarkers can potentially be used to measure a drug’s effectiveness earlier and with less invasive testing. If this consequently cuts down on the number of tests required – and the time it takes to approve life-saving drugs – this is a definite positive, not a negative.

In reducing the time it takes to approve drugs, Gottlieb and the FDA are proactively adapting to the quiet revolution going on in biotech, not trying to turn the clock back.
When viewed as part of an administration pursuing deregulation as its core principle, Scott Gottlieb may seem like an opponent to the anti-Trump camp. But look deeper, and you will find a determined individual whose goal is the mitigation and eradication of disease. A physician as well as a survivor of Hodgkin’s lymphoma, Gottlieb has deep insight into what it is like to be both a caregiver and patient. He had personally been given a diagnosis which he then reversed through treatment and hopes that more people with illnesses can experience the same feelings of relief and joy when told that they are no longer sick. Accordingly, he is guiding the FDA toward a future based on the most cutting-edge innovation in biotech.

As Gottlieb noted in his fall 2018 Agenda, his goal is not deregulation in and of itself, but “Leveraging innovation and competition to improve health care, broaden access, and advance public health goals.” There is little reason to believe that faster drug approval will mean less effective drugs. On the contrary, it’s possible faster drug approval will lead to better, more effective drugs, and the mitigation of disease before crippling or fatal symptoms occur. And regardless of where you stand politically – whether you love or loathe Donald Trump – that is undoubtedly something to celebrate.

Kevin Hrusovsky is founder and chairman of Powering Precision Health.