About six months ago, the Reagan-Udall Foundation sent the Food and Drug Administration its Operational Evaluation of FDA's Tobacco Program. this is a report that the FDA itself requested in July of 2022. How is the Center for Tobacco Products (CTP) implementing the recommendations of the report to date?

I was skeptical that the report would be anything more than a whitewash, calling only for more funding and more authority for the CTP. However, the report proved me wrong: it was thorough, specific, and hard-hitting, calling for many substantive changes in how the CTP operates.

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When Robert Califf was selected by President Biden for a second stint as FDA commissioner, we called it a safe but uninspired choice. Unfortunately, we have been proven right.

Califf is a distinguished academic cardiologist and clinical trial specialist, but the day-to-day regulatory decision-making happens at organizational levels below the commissioner, and he seems unwilling to engage with them. He has also made it clear that he's not interested in criticism from the public, even though the FDA is required by law to consider public comments as part of the rule-making process.

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If there's a silver lining to the Covid-19 pandemic, its a renewed focus on the importance of science in policy-making. The credibility of our scientific institutions are essential to every aspect of our lives.

Yet, perhaps because of their critical importance, those institutions remain vulnerable to manipulation by special interests.

Consider the latest development in a long-running effort to prevent sugar cane farmers in Florida from continuing their use of prescribed pre-harvest burns.

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The Food and Drug Administration has problems in many of the product areas it oversees. These include the slow approval of drugs, unnecessary and prolonged shortages of infant formula, and the problematic, ineffective regulation of tobacco products. To his credit, FDA Commissioner Dr. Robert Califf seems to realize his agency has issues.

He commissioned a report to recommend corrective actions.

So far, so good.

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Kudos to Food and Drug Administration Commissioner Dr. Robert Califf for acknowledging his agency needs help. Recognizing a problem is a prerequisite to making amends.

On July 19th, Califf conceded, as only a government official could, "the agency has confronted a series of challenges that have tested our regulatory frameworks and stressed the agency's operations, prompting me to take a closer look at how we do business." He also commissioned a report to help figure things out.

The FDA's bungled response to contamination at the Abbott Nutrition infant formula plant in Michigan drew attention to broader problems within the agency's food regulation bureaucracy.

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