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From Health Law Daily, April 5, 2017

Gottlieb’s ‘financial entanglements’ troubling or heartening, depending on the senator

By Sarah E. Baumann, J.D.

FDA Commissioner nominee Scott Gottlieb, M.D. answered questions about his financial ties to a venture capital firm at an April 5, 2017 confirmation hearing before the U.S. Senate Committee on Health, Education, Labor & Pensions (HELP). Democratic senators expressed concern over his ties to New Enterprise Associates (NEA) and his investments in life sciences companies, while Republicans viewed his work with those organizations as evidence of his experience. Gottlieb also responded to questioning regarding his views on the FDA’s role in combatting the existing opioid crisis and balancing drug approval speed with safety.

Gottlieb, a cancer survivor and former Deputy FDA Commissioner, is a physician who serves as a clinical assistant professor at a medical school and a resident fellow at a conservative think tank. However, opposition senators were more interested in what Sen. Patty Murray (D-Wash) called his "unprecedented financial entanglements," particularly his role as a partner in NEA, which invests in various health companies, including medical device companies, and his pharmaceutical company investments. Gottlieb responded that he effectively served as a consultant to NEA, but that he generally did so with respect to health care services, rather than life sciences and medical device issues. He also stated his belief that he is "uniquely suited" to preventing entities from abusing the regulatory process to gain unfair advantages in the market. A number of Republican senators commented on Gottlieb’s extensive experience and knowledge which resulted, in part, from his NEA partnership. Sen. Lamar Alexander (R-Tenn) noted that most of the criticism was directed at work that was relevant to Gottlieb’s future work at the FDA.

Many senators asked Gottlieb to address the opioid crisis, which he characterized as "a public health emergency on the order of Ebola and Zika." Gottlieb emphasized the need to "look harder" for generic drugs with abuse-deterrent features, and also proposed alternatives to drugs, such as medical device therapy options, although Sen. Tammy Murray (D-Wis) noted that NEA had invested in a medical device company. Given the extent of the epidemic, the nominee noted that the FDA may have to take more "dramatic" steps than it would have a decade ago.

Gottlieb was also asked about balancing patient safety with accelerated FDA drug approvals. The nominee "reject[ed] a false dichotomy that it all boils down to a choice between speed and safety." Referring to recent passage of the 21st Century Cures Act (P.L. 114-255), he argued, "if we’re doing our jobs and leveraging the authorities you have given us . . . we can have better efficiency, and better safety, and also remain faithful to FDA’s gold standard for regulatory conduct." He emphasized his commitment to a strong workforce in response to Alexander’s expressed concern about a government hiring freeze.

Companies: New Enterprise Associates

MainStory: TopStory NewsStory SenateNews FDCActNews ControlledNews DrugBiologicNews FraudNews GenericDrugNews MDeviceNews PrescriptionDrugNews SafetyNews

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