Scott Gottlieb and Reforming the FDA

In his first address to Congress last month, President Trump criticized the Food and Drug Administration’s “slow and burdensome” drug approval process for preventing “too many advances…from reaching those in need.” Indeed, the FDA has repeatedly proven to be a bureaucratic quagmire that slows the development of effective, affordable medication and helps to inflate the price of some drugs to absurd levels.

Needless to say, the FDA is in need of some significant reforms.

Enter Scott Gottlieb – President Trump’s pick to save the sinking ship. As a physician, investor, health policy analyst, and former Deputy Commissioner for Medical and Scientific Affairs at the FDA, Gottlieb has extensive experience tackling public health issues in the public, private, and nonprofit sectors.

Gottlieb is familiar with the inner workings of both the government and the pharmaceutical industry, and recognizes the importance of balancing the need for meaningful regulations with providing consumers with affordable options. Naturally, this makes Gottlieb a superb pick to head an agency that has long been plagued by mismanagement and ineffective policies.

Several Democratic senators have raised concerns about Gottlieb’s ties to the pharmaceutical industry, calling him a “dangerous” pick to head the agency. However, Gottlieb has already vowed to recuse himself from agency decisions that might present a conflict of interest. Democrats also claim that Gottlieb’s lack of an academic science background makes him unqualified for the position, but this actually strengthens the case for Gottlieb.

According to the American Enterprise Institute’s David Shaywitz, Gottlieb “can leverage his experience as a company builder (along with his experience as a doctor, policy wonk and cancer patient)… to unleash the latent passion within the FDA and inspire its innate creativity.” Gottlieb’s knowledge of the public health issues that exist in both the public and private sector shouldn’t disqualify him from the position – it should have both Republicans and Democrats scrambling to confirm a man who might actually be able to fix the agency once and for all.

At his confirmation hearing before the Senate Health, Education, Labor and Pensions Committee, Gottlieb clearly stated his intentions to prioritize efficiency as head of the FDA while also being aware of necessary safety standards. Gottlieb rejected the “false dichotomy that it all boils down to a choice between speed and safety.” Instead, he asserted, “We can have better efficiency and better safety and also remain faithful to FDA’s gold standard for regulatory conduct.”

It’s clear that Gottlieb represents a shake up for the FDA, but given the numerous problems that have stemmed from the agency’s history of mismanagement, that isn’t necessarily a bad thing. Indeed, Gottlieb’s leadership could “introduce a new regulatory paradigm focused on competition to accelerate innovation, dramatically shorten the time from development to patient access, and sharply reduce the prices for new drugs – all to the ultimate benefit of patients.” It’s hard to see how any of this would make Gottlieb a “dangerous” choice to head an agency in need of some significant changes.