On May 11, Dr. Scott Gottlieb was sworn in as the 23rd Commissioner of Food and Drugs. A New Jersey native, Dr. Gottlieb is physician specializing in internal medicine at the NYU Langone Medical Center, a clinical assistant professor at the New York University School of Medicine as well as a resident fellow at the conservative think tank The American Enterprise Institute.
What Does the FDA Commissioner Do?
The Commissioner of the FDA oversees the The Food and Drug Administration (FDA), a 15,000 person, $5 billion federal agency of the US Department of Health and Human Services. The FDA is responsible for protecting and promoting public health primarily through the enforcement of the Federal Food, Drug and Cosmetic Act, a set of laws passed in 1938 that gives the FDA the authority to regulate food, drug and cosmetic safety. Importantly for food and farming, the FDA also implements the Food Safety Modernization Act, a law signed by President Obama in 2011 that provided the biggest overhaul of food safety laws in 70 years by shifting the agency's focus from responding to food contamination and safety problems to preventing them.
The USDA and FDA both play critical roles in regulating food safety in the US, but sorting out who regulates what foods and why is incredibly confusing. To spare you the wonky details, here is our cheat sheet version of what the FDA regulates:
- Imported foods
- Food additives and drugs given to food animals (but not vaccines for animals - this is overseen by the USDA)
- The pasteurization of milk
- Infant formula
- Shelled eggs
- All other foods except meat, poultry and egg products (these are all regulated by the USDA too)
Who Is Scott Gottlieb?
Scott Gottlieb, a practicing physician, attended medical school at the Mount Sinai School of Medicine and completed his residency in internal medicine at Mount Sinai Hospital. He's also a former member of the editorial staffs of the prestigious British Medical Journal and the Journal of the American Medical Association.
As a medical policy expert and public health advocate, Gottlieb has worn many hats in the federal government over the past decade. From 2005 to 2007, Gottlieb served as both the FDA's Deputy Commissioner for Medical and Scientific Affairs and as a senior advisor to the FDA commissioner, where he worked on the development of the FDA's generic drug user fee program. He was also a member of the White House Biodefense Interagency Working Group convened after September 11th to help create a strategic plan for protecting the US against biological attacks. And in 2013 he was appointed by Senate Majority Leader Mitch McConnell to serve as a member of the Federal Health IT Policy Committee which advises the Department of Health and Human Services on health care IT issues.
Gottlieb also has many deep ties to the pharmaceutical industry - which he will now be regulating in his role at FDA. He's served as an independent director at the biopharmaceutical companies Tolero Pharmaceuticals and Daiichi Sankyo, Inc. and as a member of the British pharmaceutical company GlaxoSmithKline's product investment board. Before the 2016 Presidential Election, Dr. Gottlieb served as a member of Trump's transition team. After news of his nomination emerged in early March 2017, he promised to divest himself from several health care companies and expressed his intention to recuse himself "for one year from any agency decisions involving about 20 health care companies he worked with" under an ethics agreement.
As a survivor of Hodgkin's lymphoma, Dr. Gottlieb has a deep personal interest in the fight against cancer, serving on the policy boards of the Leukemia and Lymphoma Society, and an advisor to Cancer Commons and the National Coalition for Cancer Survivorship.
What are Gottlieb's Priorities and Vision for the FDA Under the Trump Administration?
Some insights into Dr. Gottlieb's priorities from the FDA can be gleaned from a 2012 article he wrote for National Affairs in which he criticized the FDA for establishing too many regulatory hurdles. He blamed these requirements on a culture that "values excessive desire for certainty" and distrusts the doctors that prescribe medication. However, at his confirmation hearing in April, Gottlieb assured senators that he would be an "absolutely objective regulatory watchdog" and would not do anything to undermine public confidence in the FDA's work.
So far, Dr. Gottlieb has indicated that he will move forward with the Trump Administration's promise to ease regulations and "cut the red tape"at the FDA to make sure that drugs reach the market more quickly by implementing the 21st Century Cures Act signed by President Obama. He's also promised to make addressing the nation's opioid epidemic a top priority. Going forward, one of the most significant decisions he will have to make in his new role as FDA Commissioner is whether he should accept proposals from the drug industry to reduce standards under which drugs can be advertised - regulations put in place 50 years ago to protect consumers and ensure that drugs are not only safe but also effective in treating patients as claimed.
What Are the Implications for Sustainable Agriculture?
Despite the fact that FDA regulates most of the food we eat, very little has been said about what Dr. Gottlieb's plans are for the food or farming industry. What we do know is that as the FDA Commissioner, he will oversee the implementation and administration of some very important programs that impact sustainable agriculture, including the Food Safety Modernization Act's Produce Safety Rule which establishes science-based standards for the growing, harvesting, packing and holding of fruits and vegetables for food and farm businesses. These rules come into effect in January 2018 for most large farms and 2019 and 2020 for most small farms.
In addition, Dr. Gottlieb will be overseeing the implementation of a voluntary program to reduce the use of antibiotics in industrial meat production. The program, which was established in 2013, has done little to curb the use of antibiotics on farms as data indicates that producers are now using more drugs per animal than they did just a few years ago. Researchers have also found that the rise in antibiotic use in the farming industry is correlated with the rise of antibiotic resistant bacterial infections in humans, which the CDC estimates kills 23,000 people per year. Of particular concern is that fact that 62 percent of the antibiotics sold to farmers in the US are medically important to humans whose lives may depend on those antibiotics. It remains to be seen what, if anything, Dr. Gottlieb will do to address the issue as the head of the FDA or whether it will be a priority for him given his ties to the pharmaceutical industry that produces and benefits from the sales of these antibiotics to farmers.