Former Deputy Commissioner Gottlieb Added to FDA Short List
Former FDA deputy commissioner Scott Gottlieb, who served under George W. Bush, has reportedly been added to the short list of candidates president-elect Donald Trump is considering for FDA commissioner under his administration. Gottlieb, who is also serving on the Trump transition team, is a resident fellow at the American Enterprise Institute and a clinical assistant professor at New York University School of Medicine. Additionally, he is a venture partner at the venture capital firm New Enterprise Associates, and a senior principal at TR Winston, a health care-focused merchant and investment bank.
Earlier this year, Gottleib, said FDA should adapt how it approaches pre-market regulation in order to properly address very novel areas of technology like gene editing and cell and gene therapy. He made these remarks at the International Society for Stem Cell Research in Berkeley, CA. The bottom line, according to Gottlieb, is that the agency needs to “more closely focus its organizational structure and its regulatory programs on measures of risk, and move away from its structural legacy that oriented its review programs mostly around discrete clinical areas of medicine. More and more, it’s the product features of these novel technologies, and not necessarily their clinical applications, that create the hypothetical and known risks. The regulatory efforts need to be structured around these product areas. That means FDA needs to organize more of its regulatory activities around programs centered on areas such as regenerative medicine and gene editing. It needs to more closely adjust its regulatory approach to address the unique nature of the different risks that it’s trying to address.”
Gottlieb has also advocated for a different regulatory scheme for mobile health apps to keep the agency’s hands off the technology in order to not stall technological advances. Instead of FDA regulating potential medical apps, Gottlieb said, the government should “subject the riskiest of these digital tools to the same sort of regulatory scheme that the government eventually fashioned for [electronic health records] EMRs. Early on, as EMRs started to gain wider use, FDA suggested that all of these software platforms met the definition of a medical device, even when they merely collected and reported data. FDA said the platforms should be subject to its oversight.”
Additionally, in a 2015 Forbes op-ed, Gottlieb complained about FDA restrictions on pharmaceutical company communications that prevent useful pharmacoeconomic information from being disseminated among healthcare providers and payers. “The end result is that there is less incentive to develop this data in the first instance,” he said. “Even if drug makers had rigorous data looking at the comparative risks and benefits of their medicines against cheaper alternatives, it’s unlikely they could share the economic aspects of these results under current FDA rules.”