Click HERE to watch Sen. Collins’ Q&A on Infant Formula.
Click HERE to watch Sen. Collins’ Q&A on COVID Antivirals.
Click HERE to watch Sen. Collins’ Q&A on Mask Mandates.
Washington, D.C.—At a Senate Health Committee hearing today, U.S. Senator Susan Collins questioned U.S. Food and Drug Administration (FDA) Commissioner Dr. Robert Califf and Centers for Disease Control and Prevention (CDC) Director Dr. Rochelle Walensky on the infant formula shortage and the ongoing COVID-19 response.
In February, a major infant formula plant in Michigan was shut down due to the presence of a deadly bacteria that has killed as many as nine children. The FDA received a whistleblower’s report on food safety issues at the plant last October, but it didn’t reach top FDA officials until February due to “mailroom issues” that were related to employees working remotely.
Senator Collins asked Dr. Califf to explain how the FDA’s remote working policy hampered the agency’s response to unsanitary conditions at the plant, which precipitated a nationwide shortage of infant formula.
“We know that the baby formula crisis was exacerbated by the fact that people weren't working in the mailroom, and that [FDA] inspectors were not working a normal schedule in the baby formula plants,” observed Senator Collins. “[Y]ou referred to a return-to-work pilot program. How many FDA employees are part of that pilot program, as opposed to working full time right now in the office or in the field?”
Dr. Califf responded that all of the employees in the pilot program are working full time, and if they hold a job where they'll do their work best if they are present, they are required to be there. He pledged to provide Senator Collins with the data on the program.
Transitioning to the COVID-19 response effort, Senator Collins asked Dr. Califf about the availability of Paxlovid, an anti-viral pill intended to alleviate COVID-19 hospitalizations and deaths for high-risk patients. Senator Collins expressed alarm at a proposal for patients not in high-risk groups who test positive to call a 1-800 number to have Paxlovid delivered to them without consulting a doctor or pharmacist.
“PAXLOVID interacts in a negative way with a lot of commonly taken medications, including blood thinners, for example. Second, just on Tuesday Pfizer announced it was halting enrollment in a trial for PAXLOVID in standard risk patients, both vaccinated and unvaccinated, after its study revealed that the treatment was not effective in reducing symptoms in that group,” said Senator Collins. “Do you really think calling 1-800 is a good way to handle the prescription of a drug that's been found to not be effective for standard risk patients and has interactions with a lot of medications?”
Dr. Califf said he wants to make sure that COVID-19 patients, particularly in rural states, have equal access to Paxlovid. But he clarified that he did not believe it would be a good idea for patients to call a 1-800 number without involving a clinician.
“I think there does need to be an intermediary, either a pharmacist or a physician who can look at the risks and the drug interactions and make a good judgment,” said Dr. Califf. “But the concept is right, that having to find a physician, get an appointment, can take over five days for many Americans. So we have to have a system that deals with that issue.”
Senator Collins went on to ask Dr. Walensky about a recent column in the New York Times that cited evidence suggesting that broad mask mandates have had a minimal effect on reducing COVID-19 caseloads over the past two years. According to the column, daily average cases per capita during last winter's surge were practically the same in counties and states that had mask mandates as those that did not.
“There are proven ways to lower hospitalizations and deaths. We know that—vaccinations, therapeutics. But mask mandates have contributed to a breakdown of trust in public health officials given the scant evidence that they actually lower caseloads. What specific data has the CDC examined that demonstrates that broad-based mask mandates lead to lower caseloads?”
Dr. Walensky responded by claiming other studies have shown decreased rates of COVID-19 due to mask mandates.