In First Speech to FDA as Commissioner, Gottlieb Emphasizes Opportunities

On Monday, days after he was sworn in as the new commissioner of the FDA, Scott Gottlieb, MD, delivered a speech to staff acknowledging the substantial challenges the agency must tackle but expressing an optimistic drive to “fulfill FDA’s special mission.”

Gottlieb, a physician and former Deputy Commissioner of the FDA, framed his speech around the agency’s importance in protecting America’s children, as he described explaining to his young daughters that he would be working to help make sure foods and medicines are safe. He made a point to thank the career scientists and previous leaders of the FDA, and said he was humbled to have the chance to lead the agency through “a time of great promise.”

First, Gottlieb reminded the audience that scientific advances are allowing for new devices and treatments like gene therapy to be developed at a rapid pace, including in FDA labs or at other federal centers. These advances, combined with the increasing regulatory scope of the FDA, “have given us better tools and prospects” to achieve the agency’s core goals of ensuring safety in foods, cosmetics, and drugs.

He singled out smoking cessation as the mission with the most capacity to prevent illness and death, saying that the FDA must focus on efforts to keep kids safe from tobacco, offer programs to help smokers quit, and look into harm reduction alternatives for smokers who cannot quit, which could refer to e-cigarettes.

Another imminent challenge is that “too many consumers are priced out of the medicines they need.” While the FDA cannot directly regulate the prices of drugs, it can and should encourage competition in the drug market by efficiently approving less costly alternatives like generics and biologics, Gottlieb said. The issue of drug pricing has been a frequently mentioned priority of President Donald Trump, who nominated Gottlieb for the position.

Gottlieb cited the 21st Century Cures Act as a “key priority” for the FDA to implement and an example of how the agency will need to pursue innovative solutions and technologies while maintaining the foremost goal of protecting public health. He also acknowledged the importance of the FDA’s food safety mission, and vowed to work closely with the Center for Food Safety and Applied Nutrition in enacting new frameworks to further this task.

However, he said the “greatest immediate challenge” is the opioid epidemic, which he referred to in his Senate confirmation hearing as a “staggering human tragedy that will require dramatic action.” Gottlieb noted that the FDA can play its part in the multifaceted efforts to curtail opioid abuse by training clinicians to only prescribe the painkillers in appropriate circumstances, and expressed his hopes to soon develop plans for “even more forceful steps to address this crisis.”

Taking a broader view of the FDA and its direction, Gottlieb said he disagreed with some employees’ feeling that the agency is in a state of uncertainty. Instead, he argued, there is “a clear and historic opportunity” to build on the continued efforts of the career workforce and “help Americans realize more opportunities from science and medicine.”

In closing, Gottlieb implored the audience to remember the unique “larger societal purpose” at the heart of their jobs, as well as his: ensuring public safety, regulating effective medicines, and making it possible for Americans to improve their health. “People can’t live a life of dignity if they don’t have access to these opportunities—if they don’t have access to the consumer protections that we provide and the tools of public health,” he said.