Potential FDA Commissioner Nominees Would Shake Up Agency


Attorneys and other experts told me that the two potential nominees for FDA commissioner, Jim O’Neill and Scott Gottlieb, both have publicly expressed ideas that would significantly change the way the agency operates.

O’Neill, a managing director at Mithril Capital Management, has said the FDA should approve drugs based solely on their safety and not, as the agency currently does, based on their safety and effectiveness. Meanwhile, Gottlieb, a resident fellow at the American Enterprise Institute (AEI), favors deregulation and loosening the agency’s requirements for the approval of medical products.

Gottlieb is the more experienced candidate, having worked at the agency as a deputy commissioner and also having a medical degree, attorneys told me. But the fact that both candidates have ties to FDA-regulated industries should disqualify them, Michael Carome, director of Public Citizen’s Health Research Group, told me.

Gottlieb served as FDA deputy commissioner for medical and scientific affairs from 2005 to 2007. In addition to being a resident fellow at the AEI, Gottlieb is a venture partner at New Enterprise Associates, a firm that invests in medical and life sciences companies. AEI is a nonpartisan public policy research institute.

O’Neil’s firm Mithril Capital Management has invested in the medical device company Fractyl Laboratories Inc. It also invested in Avitide Inc., a manufacturer of purification solutions for the biopharmaceutical industry. O’Neill last served in government during the George W. Bush administration as principal associate deputy secretary at the Department of Health and Human Services.

My full story is at https://www.bna.com/potential-picks-lead-n73014448800/.

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