Former FDA Director Califf: Congressional 'Dysfunction' is the Biggest Challenge Facing the FDA

Key points:

1. Former US FDA Commissioner Robert Califf pointed out that the "dysfunction" in Congress is the biggest challenge facing the FDA.
2. He believes that the United States has failed to establish an effective regulatory system to address public health controversial products such as e-cigarettes, marijuana, etc., and that congressional division is a key reason.
3. Regarding e-cigarettes, Califf supports the Australian model of selling them in pharmacies, but acknowledges that the American belief in personal freedom hinders the implementation of similar policies.
4. He suggested that his successor, Marty Makary, should prioritize internal professional teams and rely on evidence to formulate policies.

According to a report by MedPage Today on April 8th, former FDA Commissioner Dr. Robert Califf admitted in an interview that the biggest challenge during his tenure did not come from the FDA itself, but from a "dysfunctional Congress.

Working in federal agencies is extremely dependent on reaching consensus in Congress, but they are fundamentally unable to communicate with each other," Califf said. "This has led to many problems that could have been solved becoming complex or even stagnant." He cited examples such as products like e-cigarettes and marijuana, which do not fully meet traditional drug or medical device standards and need independent regulatory systems, but the divided stance in Congress is preventing progress.

On the issue of e-cigarettes, Califf agrees that they can serve as harm reduction tools under certain conditions, but he points out that the emphasis on individual freedom in American society makes it difficult to implement strict regulatory measures.

If I were king, I would adopt a system similar to Australia's where e-cigarette products must be purchased from pharmacies as part of nicotine addiction treatment. However, in the United States, it is your freedom as long as you are over 21 years old and desire to vape e-cigarettes.

He further pointed out that current US law only requires manufacturers to obtain approval from the FDA, without limiting the intended use by adults. He emphasized the need to protect children, but respect for adult freedom poses a regulatory dilemma.

When it comes to the new FDA Commissioner Dr. Marty Makary, Califf proposed three suggestions.

• A deep understanding of the internal team: The FDA has many professional talents, and it is crucial to understand their experiences and advice. 
• Respect for evidence: Policy-making must be based on ample data support, especially in controversial areas. 
• Realistic awareness of limitations: With over 20% of FDA employees being dismissed upon the new director's appointment, along with frequent political interference, future work will be exceptionally challenging.

Califf emphasized that the public should recognize that the FDA is not the "team owner," but rather the "referee." "Congress is the rule maker, and we can only enforce within that framework." He called on society to reconsider the responsibilities and powers of the FDA, especially against the backdrop of increasingly prominent cross-sector issues such as food, nutrition, and new addictive products.

Califf served as the Commissioner of the United States Food and Drug Administration (FDA) twice. He first held the position from 2016 to 2017 and then again from 2022 to 2025.