Applied Clinical Trials
Gottlieb’s tenure included record new drug approvals and steps taken to curb opioid abuse.
Nothing like bowing out at the top of your game. FDA Commissioner Scott Gottlieb’s surprise announcement of his plan to leave FDA in a month comes at a time when the agency and health policy makers can chalk up multiple successes. FDA approved record numbers of new drugs and generic products in the two years of Gottlieb’s tenure, tackled important clinical research issues, and took steps to promote competition and innovation in the biopharmaceutical industry. And the commissioner was successful in navigating the political pitfalls of Washington to gain a notable increase in funding for the agency, at a time of lean budgets for many federal programs.
Two critical public health issues drew considerable attention from Gottlieb. He took steps to curb inappropriate prescribing of opioids while also encouraging the development of safer and more effective painkillers. He currently is promoting a high-profile campaign to further reduce the use of tobacco, particularly teen “vaping” and flavored cigarettes.
Gottlieb supported a range of initiatives for bringing innovative medical products to market. He recently highlighted the importance of industry investment in modern drug manufacturing systems to ensure product quality and reduce shortages. He backed new approaches for overseeing cutting edge-gene and cellular therapies and encouraged more streamlined development and oversight for breakthrough treatments with potential to save lives and tackle serious illnesses.
In an administration troubled by scandals and vehement partisanship, Scott Gottlieb stood out as an effective and knowledgeable policy maker and administrator, winning praise from conservatives for facilitating innovation in the biopharmaceutical industry, and from liberals for promoting competition likely to reduce drug costs and increase patient access to medicines. He avoided pressure to launch a highly deregulatory agenda with weaker oversight of industry, while gaining support from biopharma companies for facilitating more drug approvals.
Yet, the commissioner leaves many important initiatives in flux. The Office of New Drugs in the Center for Drug Evaluation and Research is in the midst of a broad reorganization that may require legislative action. And drug pricing remains highly contentious and could undermine FDA’s traditional opposition to widespread importing of medical products. Gottlieb promoted efforts to increase the use of real-world evidence and to streamline research practices to accelerate drug development and testing, despite loud concerns that such approaches exposed patients to drugs not fully documented as safe and effective.
Despite these FDA efforts, adulterated and poor-quality drugs have continued to emerge, often resulting in drug shortages and concerns about the agency’s ability to monitor the growing volume of drug products and ingredients imported from overseas. And despite Gottlieb’s emphasis on the need to streamline and improve FDA’s ability to hire and retain quality scientists and experts, staff shortages remain a serious problem for the agency.
Only a few weeks ago, Gottlieb insisted publicly that he had no plans to leave FDA, so his resignation surprised many Washington insiders. His stated reason is the desire to end his weekly commutes from Connecticut to DC in order to spend more time with his young family. President Trump indicated support for Gottlieb, as did leaders of Congress and industry. The administration will name an acting commissioner, who may hold that position for months to come. And with expert command of social media, we may hear more from Gottlieb in the future.