Don’t let Dr. Scott Gottlieb’s work go up in smoke

Earlier this month, Food and Drug Administration Commissioner Dr. Scott Gottlieb suddenly announced that he will leave the agency at the end of the month. We fear that this leadership change could have adverse consequences for public health policy in the Trump administration.

When President Donald Trump nominated Dr. Gottlieb to lead the FDA, many people worried that Gottlieb’s strong ties to the pharmaceutical industry and past support for loosening regulations meant that he would not serve the public interest. Two years later, we have been pleasantly surprised by Dr. Gottlieb’s leadership and are concerned about what his departure will mean for some of the important initiatives he has promoted.

President Trump ran on an anti-regulatory agenda and many of his nominees pursued that direction. Instead, in Dr. Gottlieb’s first days on the job, he took action to regulate opioids, expressing regret that the FDA had failed to act sooner.

Tobacco control advocates welcomed Gottlieb’s September 2018 declaration that ‘vaping’ is an epidemic. He has since proposed restrictions on the sale of flavored e-cigarettes and other tobacco products that appeal to young people and has chastised several companies for selling tobacco products to minors.

Nearly all tobacco users start young and tobacco use remains the leading cause of preventable death and disease in the United States. E-cigarettes have been the most commonly used tobacco product in the United States since 2014. Between 2017–2018, use among high schoolers surged by nearly 80 percent. That sudden uptick among young people threatens to unravel decades of progress to reduce smoking.

While e-cigarettes are a relatively new threat, the rise of antibiotic-resistant bacteria has long been on the FDA’s radar. A recent estimate suggests that up to 162,000 Americans die each year from antibiotic-resistant infections, making it the third leading cause of death in the United States. The World Health Organization ranks those infections among its top health threats, warning that without swift action we could soon live in a world where antibiotics no longer work.

Nearly two-thirds of the antibiotics important to human medicine sold in the U.S are for use in meat production, often to compensate for unsanitary, overcrowded, and stressful living conditions. Dr. Gottlieb introduced a five-year plan to address overusing antibiotics in meat production — and contributed ideas on how to effectively develop new antibiotics.

Now, with Gottlieb’s departure, tobacco and e-cigarette companies are breathing a sigh of relief. His other initiatives, including his plan to combat antibiotic overuse, may fall by the wayside if his replacement has different values and priorities.

Given the health risks of e-cigarette use and their increasing popularity among young people, the next commissioner should make good on Gottlieb’s threat to pull e-cigarettes off store shelves immediately pending further review and regulation. The American Academy of Pediatrics recently sued the FDA to take that action. Additionally, we urge the next commissioner to move forward to ban e-cigarette advertising and flavorings — such efforts have helped to decrease the prevalence of teenage smoking.

The next commissioner should also quickly implement Gottlieb’s five-year action plan on antibiotics, including setting limits on how long antibiotics can be used. About 30 percent of medically important antibiotics approved for use in food producing animals have label indications with open-ended or undefined durations of use. Meat producers can use the drugs continuously on large numbers of animals, with no end date. That’s a surefire recipe for breeding antibiotic-resistant bacteria. The FDA should set duration limits of no more than 21 days for all medically important antibiotics used in meat production.

We’re sad to see Dr. Gottlieb go. We hope his successor shows the same active spirit in addressing these critical health threats. Taking on the e-cigarette epidemic and the antibiotic resistance crisis will make Americans healthier and safer.

Authored by:

Matthew Wellington

U.S. PIRG Director, Campaign to Stop the Overuse of Antibiotics

Saul R. Hymes, MD, FAAP

Medical Director of Pediatric Antimicrobial Stewardship

Assistant Professor of Pediatrics

Stony Brook Children’s Hospital

Stony Brook University Renaissance School of Medicine

Steering Committee Member, Clinician Champions for Comprehensive Antimicrobial Stewardship (CCCAS)

Rachel Boykan, MD, FAAP

Clinical Associate Professor, Department of Pediatrics

Stony Brook University School of Medicine

Associate Director, Pediatric Residency Training Program

Attending Physician, Stony Brook Children’s Hospital