Q&A on Medical and Food Safety Advocacy

Q: Why should those involved with medical products (research advocates, patient groups, industry) care that FDA is experiencing difficulties with its human food safety programs?

A: The easy punchline is “because we all have to eat.” However, the more specific and more serious answer is that FDA is devoted to safe food and safe and effective medicines. It is viewed by the public as one organization. If “FDA is the gold standard” is challenged for foods, it also affects the public’s view of FDA as the gold standard for medical products. The reverse is also true: any challenge to FDA’s gold standard for medical products affects the agency’s standing as the world’s premier food safety agency.

Q: Why were there mixed reactions to Commissioner Califf’s announced food safety reforms?

A:  The Alliance, along with most of the food community, has advocated for food leadership empowered to make decisions so that monies can be spent effectively and with appropriate intentionality. Although we took no position on different organizational options, Commissioner Califf creation of a Deputy Commissioner for Human Food appears to satisfy our position, pending additional details that FDA has said it will release by the end of February.

Those groups with less favorable reactions were primarily focused on the ambiguous relationship between the new Deputy Commissioner and the Office of Regulatory Affairs, which will also have some changes.  Many advocates want all food inspectors reporting to the new Deputy. How that will work and whether it represents less than full control are questions that we believe will be answered in the end of February announcements.

Another issue that came up in various responses is the status of CVM. As proposed, the Center would not report to the Commissioner through the new Deputy, which recognizes that CVM is responsible for both animal food and animal medicines. Again, we would expect more clarification in the next set of announcements.  

Q: How will this year’s budget battle be resolved?

A: No one knows. The need to increase the debt ceiling by summer 2023 has created a perceived stand-off.

House Republicans (and at least some Senate Republicans) say they are not willing to increase the debt ceiling without major spending cuts in FY 24—which presumably would take the form of budget ceilings much lower than actual FY 23 spending. The President and most Democrats in both the House and the Senate are against sweeping cuts and are unwilling to consider budget policy or spending changes tied to the debt ceiling.

Both sides cannot get what they want and there is no obvious compromise. FDA and all domestic discretionary programs will have to live with this uncertainty, perhaps for months. Congressional leaders also have no idea—they like to control the narrative when they can—but this story is not yet written and there is no recent precedent to say how it might end.