What This Contender for FDA's Top Job Could Do His First 6 Months on the Gig

What This Contender for FDA's Top Job Could Do His First 6 Months on the Gig February 21, 2017
By Alex Keown, BioSpace.com Breaking News Staff

WASHINGTON – Pharmaceutical and biotech industry insiders are waiting with bated breath to see who President Donald Trump appoints as the new commissioner of the U.S. Food and Drug Administration.

Of all the names floated so far as possible commissioners, one name has stood out as a welcome possibility by industry leaders—Dr. Scott Gottlieb, a former deputy commissioners at the FDA. Gottlieb has strong ties to the pharmaceutical industry and currently serves as an adviser to several companies, including GlaxoSmithKline . Unlike the other names circulated as potential candidates, including Joseph Gulfo, the former chief executive officer of Mela Sciences and Jim O’Neill, a longtime colleague of Trump transition team scientific adviser Peter Thiel, Gottlieb is not seen as a disruptor, someone who would come in with the intention to deregulate or dismantle the FDA.

This morning Endpoints laid out what could be an agenda for Gottlieb’s first six months on the job if he was tapped. The possible reforms he could make are based on comments Gottlieb has previously made in public, EndpointsJohn Carroll said. Some of those include reforming FDA rules for approving complex generic drugs, something Gottlieb has called for in the past, Carroll reported. In his article, Carroll said there is a “long list” of complex generics that can be sped along through regulatory channels—he would just need the right legislation to approve that change, which could be accomplished with a Republican controlled House and Senate. In previous remarks Gottlieb made to Congress, as well as in other forums, Carroll points out that if Gottlieb were selected and followed through on these previous ideas he’s floated, he would “earn a lot of support from the public as well as lawmakers.” While pharma companies will try to protect their drugs, if Gottlieb were successful in pushing through the top 10 complex generics awaiting approval, Carroll said that would reduce healthcare costs by billions and usher in new competition.

Another area where Gottlieb could make a difference is with the FDA’s breakthrough therapy designation program. Based on previous remarks and writings, Gottlieb has called for streamlining the FDA’s process for approving drugs with the designation.

Another issue that Gottlieb could lead on is transparency, particularly when the FDA rejects a drug. Carroll said Gottlieb has been a proponent of publishing Complete Response Letters, which would prevent drug companies from distorting or concealing why a drug was rejected. In a column he wrote in 2010, Gottlieb said the FDA’s disclosure of Complete Response Letters would keep developers on the straight and narrow path as they design trials and map a regulatory pathway most likely to succeed,” Carroll reported.

Gottlieb earned his medical degree from Mount Sinai School of Medicine and holds a bachelor’s degree in economics from Wesleyan University. He is currently a venture partner at New Enterprise Associates and resident fellow at the American Enterprise Institute, a conservative think tank. In addition to his roles at AEI, Gottlieb advises the U.S. Department of Health and Human Services as a member of the Federal Health Information Technology Policy Committee. Gottlieb served several years at the FDA and has a strong understanding of the agencies role. From 2003 to 2004, Gottlieb was a senior adviser to the FDA commissioner and then the agency’s director of medical policy development. In 2004, Gottlieb took on a role as senior adviser to the Centers for Medicare and Medicaid Services. And then from 2005-2007, he served as the FDA's deputy commissioner for medical and scientific affairs.

Earlier this month, Mizuho Securities USA conducted a survey of 53 drug companies asking which of Trump’s potential FDA commissioner candidates was preferable. Gottlieb was the overwhelming favorite, garnering 72 percent of the vote, Endpoints noted. O’Neill received 8 percent of the vote and Gulfo took in 9 percent. Another potential candidate, Balaji Srinivasan, the co-founder of Counsyl Inc., received 2 percent of the vote.

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