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

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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: As someone who managed the FDA, I would like to hear your point of view. The administration just stated that there is a baby formula shortage because of one company and the FDA doesn’t have to be responsible for the safety of that particular plant. I wonder how you respond to that.

DR. GOTTLIEB : These were problems that persisted and seemed to have been poorly handled by the company. FDA did not exercise all of their oversight over that facility. The facility had problems dating back to many years and was found out by 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 led to more aggressive actions earlier. Abbott has shut down the facility and no production will continue, I believe. The facility will be difficult to clean up. It will be difficult for the agency clear the allegations about data falsification and the overflow of other allegations. They may not be able prove causality between infections seen in children and those at the facility. This is something that the agency might never prove.

MARGARET BRENNAN: Mm hmm. The FDA failed to do everything it could, you just stated. They didn’t inspect the Abbott facility in 2020.. They stopped checking some areas that were not mission-critical during the pandemic. Isn’t baby formula mission critical? What is the reason 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, particularly since I was there – and especially considering the previous findings. It is concerning that FDA found five strains of Cronobacter in the facility. Based on what was found in the 483. report, it doesn’t seem to have been an advanced facility. They should have had close surveillance. We have the best of both worlds. Our regulatory system is so strict that it does make 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 control over the resultant 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 disruption that makes it very difficult to fix. The facility will eventually have to be reopened. It’s not clear when that will happen.

MARGARET BRENNAN It’s likely that the FDA commissioner will be asked about this on Capitol Hill. You said that it was a market in crisis and are pointing out regulatory failures. According to the whistleblower, they did not keep proper records and gave untested formula. This report contains a lot of accusations. Do you think this sounds like criminal behavior?

GOTTLIEB: Potentially. That whistleblower report was also sent to FDA’s Office of Criminal Investigations. It appears that the whistleblower was a skilled one. This FDA division has nine employees. It was smaller when I was there. The organization has grown over the years, and budget requests were made to expand it. The entire country’s industry is now overseen by nine individuals. For a long time this has been a low-resourced area of the agency. This is contributing to the challenges the agency faces, as it tries to exercise more rigorous and efficient oversight. Those allegations will be difficult to prove. Another issue is that some of the whistleblowers who were interviewed by FDA may also be making statements to FDA about safety at 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 end of the break to continue our conversation. Stay with us at Face the Nation.

(COMMERCIALS)

MARGARET BRENNAN: Welcome back to Face the Nation. Now we want to talk with Dr. Scott Gottlieb, former FDA commissioner and Pfizer board Member. We’ve talked about the shortage of baby formula, Dr. Gottlieb. You asked me about COVID. However, to follow up on what you just said, you indicated that there were only nine individuals who are responsible for overseeing the whole baby formula industry. Nine?

GOTTLIEB: That’s right. When I first started with the FDA, I’m sure there were at least three. This group received additional resources. Since then more resources have been added and the current administration has requested a budget to hire four additional people. However, there are only nine individuals who currently oversee and oversee all aspects of the American industry. It was much lower than this just a few years back.

MARGARET BRENNAN: That’s astounding. I have a question about COVID. This week, we reached a horrendous milestone of one million deaths in the entirety of the 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 Dr. Walensky that both have begun wearing masks indoors. There is concern that there may be an increase in the number of people who are using masks. Which trend lines do you see? Which direction are we heading?

GOTTLIEB – We are definitely experiencing a rise in infection, especially in the Northeastern and mid-Atlantic. The infections seem to be peaking if you take a look at what is happening in these states (New York and Connecticut). This is mostly due to the new Omicron Omicron B.2 variant. 12.1 that appears to be more contagious and have more immune escape than prior variants of Omicron. Most people infected by Omicron are not people with previous B 1 infections. But some portion of the 40% of people who escaped the prior wave of Omicron and are now getting caught by this current wave. My belief is that the number of cases will decrease. Overall, the cities’ wastewater data shows that there are fewer cases and we should not have an epidemic this summer. There are many models that show an increase in infection, but this is what it shows. We didn’t see it in 2020.. We didn’t see it in 2021 when B117 emerged in the spring. This summer is a good time to stop the spread of this variant. However, it can pose a threat for fall. It will be crucial to find out if the newly-formulated vaccines currently in development will adequately cover the B2 variant. They will, I hope. They will. But that is yet to be determined.

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 received a briefing last week on a model showing a surge in infection during the summer, as B2 moves into the Midwest. It is possible. However, other experts disagree. You may see some slow-burning through the summer. It’s likely you will see your infection rates 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 second spring, infections dropped. After a quiet July and August, Delta arrived in late August to bring on a new wave. That’s likely the new pattern that we will see, with June, July and relatively low levels of people feeling safe. As we enter the summer months, 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 insights.

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