Q&A Monday

This week’s questions:

• State public health officials are having to make difficult decisions about whether to follow CDC guidance on vaccines and other topics. Could there be a similar erosion of trust by states regarding FDA guidance?

• Anti-vaccine policies poll poorly and Republicans are worried that Secretary Kennedy’s approach could hurt them in the 2026 election. What do you think?

This week’s questions:

• Is there something that received less attention but particularly concerns you? (Yes, termination of the Household Food Security survey)

• Will there be a government shutdown? What are the likely impacts for FDA if there is one?

This week’s questions:

• Is Secretary Kennedy at risk of losing his job?

• What is Kenvue? Doesn’t J&J make Tylenol?

• How realistic is it to dramatically shorten product review cycles?

This week’s Q&A Monday features these questions:

• What’s at stake when a CDC director won’t sign off on the Administration’s vaccine policies, is fired, and several senior center leaders resign?

• What happens next at CDC?

• What are the possible impacts of the CDC situation on FDA and NIH?

This week’s Q&A Monday features these questions:

• Did your column on MAHA intend to deliver a specific message to journalists and lead advocacy groups?

• What is the most critical FDA issue in September?

• What are some FDA issues that are simmering and will eventually surface?

• Do you have suggestions for how I (and others like me) can take meaningful action or contribute to defending FDA, NIH, and CDC?

This week’s Q&A Monday features these questions:

• Why has CDRH seemed uniquely untouched by this year’s upheaval at the FDA?

• How does the WSJ editorial on drug approvals (here) relate to your late July article (here) calling for a National Agenda for Advancing Therapies for Chronic Progressive Diseases?

This week’s Q&A Monday features these questions:

• Were you surprised by Dr. Prasad’s return to the agency?

• How important is Dr. Kessler’s citizen’s petition and why do you think it moves the needle on the ultra-processed foods debate?

This week’s Q&A Monday features these questions:

• What is FDA’s most pressing top-down need over the next few months?

• Does USDA’s plans to move more staff to regional centers have any consequences for FDA?

• Why did you choose to write about the need for better understanding and tools to evaluate chronic progressive diseases that are severely disabling or fatal?

This week’s Q&A Monday features these questions:

• Is there a “revolving door” issue with Dr. Tidmarsh’s appointment as head of CDER?

• Why is the Administration so apparently indifferent to the need for national investment to avoid falling behind China in the life sciences?

• What is an important story that is not being widely discussed? (FDA’s headcount)

This week’s Q&A Monday features these questions:

• What do you think of this week’s FDA panel on HRT therapy for menopausal women?

• Is there any current issue that you feel is not getting the media attention it deserves?

• What are standards of identity--why do we have them, why is FDA withdrawing some now?

This week’s Q&A Monday features these questions:

• What is the farthest reaching, most consequential idea that you have advanced in FDA Matters?

• What concept has been the most useful in explaining FDA during H1/2025?

• A subscriber asked: your June 30 column, “All of Us Need to Be Rooting for FDA” (here) is an interesting take. Are you hearing a lot of stakeholders rooting for FDA failure?