The approval of Scott Gottlieb, MD, as FDA Commissioner would place a staunch advocate for biosimilar development at the head of the drug approval agency. Gottlieb’s past writings and actions signal his support for speeding up the pipeline for “robust pharmaceutical innovation.”
After a whirlwind of rumors on March 10, President Donald Trump confirmed that he would nominate Gottlieb to lead the FDA. Gottlieb, who had widely been considered the frontrunner for the position, is a less radical choice than other names that had been hypothesized for the post, but if confirmed he could have a transformative impact on the drug approval process, including the pathway for biosimilars.
Industry experts say Gottlieb favors a more rapid pace of drug approvals, but without discarding current safety and efficacy regulations. He has also advocated for greater transparency during the approval process, saying that the FDA should publicly release the complete response letters it sends when it rejects a drug application, instead of keeping them under wraps as they are now.
Perhaps the biggest clue into Gottlieb’s stance on biosimilar regulation comes from a Forbes column he penned with Gillian Woollett, MA, DPhil, in 2013, where they discussed how policy compromises can balance innovation and value, adding that “biopharmaceutical innovation is increasingly dependent on a functional regulatory path for quality biosimilars.”
Specifically, he praised the European Medicine Agency for its “abridged regulatory process that creates genuine savings,” while the FDA had yet to “make key regulatory decisions” regarding interchangeability, bioequivalence, and labelling indications. Biosimilars’ promise of innovation, he cautioned, “will be put at risk if policy makers start to implement blunt measures to restrict the pricing and access to these drugs by policies that reduce the market-based incentives that have attracted capital into these endeavors.”
Gottlieb’s support for biosimilars dates back even before the FDA implemented the Biologics Price Competition and Innovation Act in 2010. He penned an article for the American Enterprise Institute in 2008 that envisioned how an abbreviated regulatory pathway for biosimilars could produce cost savings and expand access to treatment. He recommended using the European Union’s biosimilar approval process as “a model for anticipating and resolving the scientific and policy issues related to biosimilars in the U.S.”
Gottlieb has worn many hats in the pharmaceutical and medical industries, but his most relevant experience was his role as deputy FDA commissioner of medical and scientific affairs under President George W. Bush. After serving as a practicing physician, he also currently works as a clinical assistant professor at New York University, is a resident fellow at the American Enterprise Institute, a Forbes contributor, and a health information technology adviser for HHS. He will have to give up these posts if the Senate confirms his nomination to lead the FDA, which appears likely.