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Regulatory Focus™ > News Articles > 2019 > 11 > FDA Nominee Hahn Faces Limited Opposition From Senate Committee

FDA Nominee Hahn Faces Limited Opposition From Senate Committee

Posted 20 November 2019 | By Zachary Brennan 

FDA Nominee Hahn Faces Limited Opposition From Senate Committee

Senators from both sides of the aisle on Wednesday offered little opposition to the new FDA commissioner nominee Stephen Hahn, while questioning him on everything from speeding new drugs to market to banning flavored e-cigarettes to drug prices and importation.

Hahn, chief medical executive of the MD Anderson Cancer Center in Houston, deflected on questions related to the Trump administration’s reversal on a plan to ban flavored e-cigarettes, but he noted: “This is an urgent crisis – tobacco and nicotine, we need to take action. Nothing is more important than protecting our youth.”

He also reiterated multiple times throughout the hearing that he makes decisions based on data, science and the law, and that he has depended on FDA for the entirety of his career in providing him with confidence in the treatments he’s prescribed. “I’m humbled to be in a position to lead that agency I trusted for my entire career,” he said.

As a lung cancer doctor, Hahn stressed the need to ensure FDA can protect the public health and ensure medical products are safe and effective. He also mentioned the need to accelerate innovation with “greater accuracy and certainty” to keep up with the pace of science. And he agreed that speeding competition is important, noting the “biosimilar pathway is crucial,” and that “anti-competitive practices should be eliminated.”

Hahn mentioned an area of "particular interest" is figuring out what endpoints could help expedite some medical product development, but he cautioned that, "we have to be pragmatic and make sure they’re validated."

In response to a question from Sen. Tammy Baldwin (D-WI) on his position on lowering drug prices, Hahn said: “I don’t spend a lot of time on the price side. But rarely a day goes by that this isn’t an issue addressed by patients – it’s an urgent issue and the American people want us to act on this. Ultimately, this is an access issue.”

On a question on drug importation, Hahn discussed FDA’s role in assessing the safety and security of the nation’s drug supply, adding: “I look forward to looking at the data and providing it to HHS.” He also committed to working with Congress on drug shortages and over-the-counter drug monograph reform.

On the role of patients in drug development, Hahn noted that physicians often make better decisions when patients are involved.

Implementing all of the provisions of the 21st Century Cures Act is another priority Hahn mentioned (here’s a look at the remaining deliverables).

In addition to support from multiple senators in the Senate Health, Education, Labor & Pensions Committee, five previous FDA commissioners under both Democratic and Republican administrations also endorsed Hahn.

According to Hahn’s public financial disclosure report, he makes more than $2 million per year in salary and bonuses at MD Anderson. And he has investments in several companies that are regulated by FDA, including Thermo Fisher Scientific, Procter & Gamble and Apple, which he said he will divest.

Senate HELP Hearing

Hahn Disclosure Report

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