Those topics look set to grow in importance, particularly as more DNA-based treatments arrive before the FDA. The Wall Street Journal reports Norman Sharpless, director of the National Cancer Institute, and Brett Giroir, assistant secretary at the Department of Health and Human Services, are already viewed as possible successors. While the FDA is riding high on some victories, such as clearing a record number of generics for market, the agency has also spurred some concern about its oversight of drug quality. A replacement will need to navigate a split Congress where Democrats now control the House of Representatives. Gottlieb said he has "no idea" what he will do next other than spending time with his three young daughters. According to Hills, the agency will surely continue to restructure how it regulates these areas to make the process more effective and transparent. Although he originally planned to stay at the agency through August, the accident helped put his priorities in order, he said. "Gottlieb has built a team of senior staff with solid GOP bona fides ... to help him stay on top of politically sensitive topics and to manage FDA's public agenda," Weissenstein wrote in a March 5 note. More clarity should come in the lead up to the leadership change. While generally considered positive, Gottlieb's impact on the FDA does raise some issues. "[T]he generic and biosimilars industry will miss this true champion of patient access," said the Association for Accessible Medicines in a statement. She suspects opioids will remain a priority, though the focus on e-cigarettes may die down somewhat — perhaps because of a "difference of opinion" between the FDA and that industry. "I was very emotional because in some respects, I'm walking away from the best job I'll ever have. He'll step down before the policy is finalized or implemented. And his unexpected departure, just two months after denying plans to step down, fanned speculation that he was at odds with the Trump administration and forced out like so many other top officials over the last two years. In his nearly two years at the helm of the FDA, Gottlieb advanced sweeping initiatives like making cigarettes minimally or non-addictive and approving generic drugs faster. Subscribe to BioPharma Dive: Topics covered: Pharma, biotech, FDA, gene therapy, clinical trials, drug pricing and much more. Sign up for free newsletters and get more CNBC delivered to your inbox. (2020). And an accelerated use of e-cigarettes among teens caused regulators to take compliance actions targeting the way such products are marketed and sold. The unexpected exit has created a number of uncertainties for the pharmaceutical industry. Gottlieb is set to step down in one month, at which point Amy Abernethy, who was recently appointed principal deputy commissioner of the FDA, could presumably helm the agency on an interim basis until HHS finds a replacement. The commute didn't bother him so much until late last year when he was on a call with a U.S. senator and his other line kept ringing. Gottlieb said his predecessor Robert Califf warned him that it's going to feel weird when his phone stops ringing the day after he leaves. That is one of the biggest and most controversial issues of his tenure: curbing epidemic levels of teen vaping. He published roughly 175 commissioner statements and gave countless media interviews, helping raise the FDA's stature and influence. Although it is a common refrain amid many departing government officials, according to Gottlieb, it's a family matter. The night before Gottlieb announced his resignation, he called his old boss and friend, former FDA Commissioner Mark McClellan. "There's perhaps nothing that could pull me away from this role other than the challenge of being apart from my family for these past two years and missing my wife and three children," he wrote in a letter to FDA staff. Their phones immediately started ringing. Outside FDA's official mandate, he also took an active role in speaking about drug pricing, at times blasting both pharmas and generic companies for gaming the system. The volume of new drug approvals, as well as the hastened speed at which those therapies are coming to market, has been met with concern about data requirements. For the last two years, Scott Gottlieb missed a lot of time with his wife and three daughters — back-to-school nights, school plays and parent-teacher conferences. He also called as many of his FDA colleagues as he could before announcing his resignation. Retrieved from, By signing up to receive our newsletter, you agree to our, FDA Commissioner Scott Gottlieb resigning, to leave in one month, Trial success for 2 coronavirus vaccines backs up early research bets, Early signs of survival benefit raise optimism around a small biotech's ALS drug, Biogen stocks up on Sage's brain drugs in $3B deal, Merck, expanding coronavirus work, buys a small biotech and its COVID-19 drug, Pfizer, with vaccine results positive, readies plans to ship coronavirus shot, Regeneron COVID-19 drug, used to treat Trump, cleared for emergency use, Trends and developments in real-world evidence. Get biopharma news like this in your inbox daily. Gottlieb noted to The Washington Post that his commute was crimping the amount of time he spent with his family. Bethany Hills, chair of FDA practice at law firm Mintz Levin, said in an interview with BioPharma Dive that Abernethy will likely serve as interim commissioner, at least early on. "Novel Coronavirus SARS-CoV-2" [Image]. Paul Tudor Jones on CNBC got personal about his daughter's recovery from the coronavirus and how he aims to help New York City's most vulnerable denizens. He'll be too known for his transparency efforts, having upended agency communications with his steady stream of releases and Twitter omnipresence. He is married and has three daughters. Novartis CEO Vas Narasimhan and Alnylam Pharmaceuticals head John Maraganore were among the biopharma executives to personally express gratitude. Ned Sharpless, currently director of the National Cancer Institute, is filling in as acting FDA commissioner after Gottlieb's last day, which is Friday. Trade groups representing the pharmaceutical, biotechnology and generics industries commended the agency head for his leadership, which many argue helped streamline and invigorate the drug approval process. Whoever takes on his role will need to navigate a split Congress Democrats. 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