FDA Policy/General

Gottlieb Joins Aetion’s Board of Directors

Former FDA commissioner Scott Gottlieb has joined Aetion’s board of directors. The health care technology company is working to deliver real-world evidence (RWE) for life science companies, payers, and regulatory agencies. As a board member, Gottlieb will advise the company as it expands the reach and utility of its Aetion Evidence Platform, a scientifically validated tool to assess the safety, effectiveness, and value of treatments, the company says.

Having served as the FDA chief from 5/2017 to 4/2019, Gottlieb was a proponent of the agency’s use of real-world evidence. “The widespread adoption of real-world evidence to the development and application of new treatments will improve the precision of prescribing decisions and help make drug discovery far more efficient,” Gottlieb is quoted as saying in a news release.

Aetion says it currently works with 12 of the top 20 biopharma firms in the world, along with leading payers. It is also working with Brigham and Women’s Hospital (BWH) and FDA to help inform the use of RWE in regulatory decisions for drug approval and safety through a demonstration project, the company says. Researchers are running RWE studies in the Aetion platform to attempt to replicate the results of 30 completed randomized controlled trials, and to predict the results of seven ongoing Phase 4 trials.

Since leaving FDA in April, Gottlieb has been appointed to the FasterCures advisory board, and Pfizer’ board of directors, including its regulatory and compliance committee and the science and technology committee. He is also a special partner at New Enterprise Association’s healthcare investment team and a resident fellow at the American Enterprise Institute. Additionally, Gottlieb is an elected member of the National Academy of Medicine.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome