Transcript: Dr. Scott Gottlieb on “Face the Nation”

The following is a transcript of an interview with Dr. Scott Gottlieb that aired Sunday, May 15, 2022, on “Face the Nation. “

MARGARET BRENNAN: And we turn now to Dr. Scott Gottlieb, former Trump FDA commissioner and Pfizer board member. Good morning to you, Doctor.

DR. SCOTT GOTTLIEB : Good morning.

MARGARET BRENAN: I’d like to hear your perspective as someone who managed the FDA. You heard the administration say that the shortage of baby formula is really the fault of one company and that the FDA isn’t responsible for making sure that things are okay at that facility. I wonder how you respond to that.

DR. GOTTLIEB : These were problems that have been persistent and seem to have been poorly handled by the company. FDA didn’t exercise all the oversight they could have over that facility. There were problems with the facility dating back many years. Also, there were findings from previous inspections. The agency had a 34-page whistleblower report in hand, making pretty serious allegations that there was data falsifications and data falsification information withheld from inspectors. These should have prompted more aggressive actions earlier. I believe that Abbott has shut down the facility and that production is halted. It will be difficult to clear the facility. The agency will have to deal with a lot of data falsification allegations. Even if they aren’t able prove a causal link between the infections we saw in children, and the facility itself, which the agency hasn’t been able so far to prove, they may never be capable of doing that.

MARGARET BRENNAN: Mm hmm. You just stated that the FDA didn’t do everything it could. We know that they didn’t inspect the Abbott facility in 2020.. They stopped inspecting certain places that weren’t critical during the pandemic. Isn’t baby formula mission critical? How is it possible that the FDA DR has not inspected the facility? GOTTLIEB: Well, look, it is mission critical, and during the government shutdown, we actually preserved inspections of infant formula plants because of the risks associated with those facilities–

MARGARET BRENNAN: When you were in office.

DR. GOTZLIEB: Probably should have been inspected, especially since I was in office and given previous findings. It is concerning that FDA found five different strains Cronobacter in the facility. Based on the 483. findings, it doesn’t seem to have been a state-of-the-art facility. They should have been closely monitored. We have the worst of both worlds. We have a strict regulatory system that makes it difficult for new entrants to enter the market. There’s only been one new entrant in the last 15 years that’s a domestically based manufacturer, company by heart. It doesn’t have enough oversight to control the resulting oligopoly. Three companies control 80% of the market to ensure that there’s no snafus that can cause shut down those facilities. When the market is so concentrated, it can cause a distributed shortage that’s very difficult to fix. They will eventually have to reopen the facility. It’s not clear when that will happen.

MARGARET BRENNAN I’m sure that the FDA commissioner will be asked about this on Capitol Hill this week. But you claim it’s a market that is broken and you point to regulatory failures. According to the whistleblower report, they did not keep proper records and released untested formula. This report contains a lot of allegations. Do you think this sounds like criminal behavior?

GOTTLIEB: Potentially. That whistleblower report was also sent to the FDA’s Office of Criminal Investigations. It appears that the whistleblower was a skilled one. This FDA division has nine employees. It was even smaller when I was there. It has grown over the years, and we made budget requests to increase its size. The entire industry in this country now has nine people overseeing it. This is a part of the agency that has been under-resourced for a long time. That’s contributing to the challenges the agency is facing in trying to exert more vigorous oversight and be more efficient. Those allegations will be difficult to prove. Another issue is that the whistleblower could be the same person who made representations to FDA about the safety and security of the facility. This could complicate matters.

MARGARET BRENNAN: We have more to talk about with you as always. Keep following us. We’ll be back on the other side of this break to continue the conversation. Stay with us on Face the Nation.

(COMMERCIALS)

MARGARET BRENNAN: Welcome back to Face the Nation. We’d like to continue our conversation with Dr. Scott Gottlieb, former FDA commissioner and Pfizer board Member. Dr. Gottlieb, we have been discussing the shortage of baby formula. I would like to ask you about COVID but to follow up on what you said, I believe you told me that there are only nine people in the country who oversee the entire industry of baby formula. Nine?

GOTTLIEB: That’s right. I believe there were three when i started at the FDA. We were able to provide more resources for this group. Since then, more resources have been added and the current administration has requested a budget to add four additional people. However, there are only nine people who currently oversee, oversee, and oversee the entire United States industry. It was much lower than that a few years ago.

MARGARET BRENNAN: That’s astounding. Let me ask about COVID. This week, we reached a horrendous milestone of 1,000,000 deaths in the entire duration of this pandemic. We’re currently averaging 326 deaths per week. We’ve made a lot of progress. We heard this week from Dr. Fauci as well as Dr. Walensky that they have begun wearing masks indoors. There is concern that there may be an increase in the number of people who are using masks. What trends do you see? Where are we now?

GOTTLIEB – We are definitely experiencing a surge in infection, especially in the Northeast and parts the mid-Atlantic. The infections are at their peak right now, according to modeling in these states, including New York and Connecticut. It’s mostly due to Omicron variant B.2 and B.2. 12.1 that appears to be more contagious and have more immune escape than prior variants of Omicron. It seems that most people infected with Omicron are not people who have been infected with it before. But some portion of the 40% of people who escaped the prior wave of Omicron and are now getting caught by this current wave. I believe that the number of cases will continue to drop. Overall, the cities’ wastewater data shows that there are fewer cases and that we shouldn’t see a large wave of infections this summer. There are models that show an increase in infection, but it is not the same as what was reported by the administration. We didn’t see it in 2020.. We didn’t see it in 2021 when B117 emerged in the spring. This summer should provide a buffer against the spread of this variant. However, it does present a risk for the possible fall. It will be crucial to find out if the new vaccines being developed will adequately cover this variant of B2. They will, I hope. They will, I believe, but it remains to be seen.

MARGARET BRENNAN: So you reject the idea of a summer surge, even though scientists like Dr. Birx, who was on this program just a few weeks ago, is predicting and seeing a trend line that makes her very concerned that could happen because it’s happened before.

GOTTLIEB: Yeah. The White House was briefed last week on a model that shows a large surge in infection during the summer, driven by B2 as the virus moves into the Midwest. It is possible, but others disagree with that model. There is the possibility that you will see a gradual decline in infection levels over the summer. It’s more likely that infection levels will drop. Remember, we thought that there was going to be a big surge last year and this summer with B117 when it emerged in the spring. As we moved into the later spring, the infection levels began to drop. We had a quiet June in July. Then Delta arrived in late August and created a new wave. That’s likely the pattern we’ll see again. June, July, and relatively low people feel safe again. As we enter the summer, B.2. 12.1 is going to emerge or B2 mostly in the south.

MARGARET BRENNAN: Dr. Gottlieb, we’ll be watching that. As always, thank you for your insight.