With a doctorate in chemistry from Princeton, Alberto Gutierrez was formerly with the FDA and is currently a partner with NDA Partners in the Washington, DC area. He was recently quoted in The New Yorker article “What Went Wrong with Coronavirus Testing in the US?” He has two sons, Daniel ’10 and Benjamin ’10, who are finishing medical school this spring.
What was your role at the FDA?
I worked for the FDA for twenty-five years, seventeen of which in what became In Vitro Diagnostics and Radiological Health—the office that regulates laboratory testing. I was the head of that office 2009–2017. We dealt with a lot of companies that made promises they couldn’t back up, including Theranos.
Whenever there’s an emergency and there are no tests, that is the office that figures out what to do about it, to issue Emergency Use Authorizations for tests. I went through swine flu, Zika, Ebola. I know well what happens during an emergency—how the agency deals or in this case doesn’t deal with it, what can happen, and what can go wrong.
What are you doing now?
I left the agency a little more than two years ago and now do consulting. NDA Partners was founded in 2003 by ex-center directors [centers within the FDA] and other FDA-ers. We mostly help small drug manufacturers go through the process of getting FDA approval, but when I joined, I brought more diagnostic expertise. I am working with companies now to get their tests for the coronavirus authorized.
You have a unique perspective on what went wrong with early testing.
There’s been a lot of discussion about who is at fault. The people on the ground were doing what they could. They needed direction from the top. There has to be close coordination with the CDC, which is the leading group trying to figure out what’s happening. Usually, they take the lead in the first test, clearing problems. All those things—when they work well—are coordinated from the top. The cuts we’ve had, including the White House office on pandemic preparedness, all affect how the government responded.