Q&A Monday

This week’s questions (answers below):

• Commissioner Makary appears to be on shaky ground with HHS and the White House. What is your reaction?

• What is going on in food policy? Are we on the right track?

• According to the Washington Post (here), Dr. Pazdur has several areas where he disagrees strongly with Commissioner Makary. How is that going to work out?

• The newly-revised CDC website states that vaccines could be a cause of autism. What do you think?

This week’s questions:

• Any initial thoughts on CDER Director George Tidmarsh’s response to being accused of abusing his office?

• Your column on national uniformity and federal preemption (here) was critical of both industry and consumer advocates who are involved in the fight over food ingredient safety. Did you wind up in hot water?

• The FDA’s newly-announced reforms of the approval process for biosimilars are being greeted with both plaudits and yawns. Which is the correct response?

This week’s questions:

• What do you think about this past week’s stories on increased lobbying by pharma (and others) this year?

• Why was your analysis (here) of the nine vouchers awarded under the National Priority Review Voucher Initiative more positive than most?

This week’s questions:

• It appears that no progress has been made to end the federal government shutdown. What happens next?

• There have been recent headlines that FDA’s FY 26 funding might be appropriated, separate from resolution of the shutdown. Is this true and how likely is it?

• FDA has announced the first nine companies to be granted vouchers under the Commissioner’s National Priority Review Voucher Initiative. What do you think?

This week’s questions:

• How long is the shutdown likely to continue?

• Did Commissioner Makary offer companies accelerated review if they make the pricing concessions requested by the Administration?

• Where does the farm community fit into the MAHA agenda?