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. Usually, when an official of Gottlieb's stature resigns in Washington or Wall Street, "spending more time with my family" is rarely the real reason. A spokesperson for the National Cancer Institute said in a statement to BioPharma Dive that the institute is not involved in decisions regarding the FDA Commissioner. Gottlieb said he has "no idea" what he will do next other than spending time with his three young daughters. "He's making it easier for companies to understand the transparency in the policy," Hills said. 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. "There was a fear that, God forbid, if something happened and I need to be home quickly, I just couldn't.". Subscribe to BioPharma Dive: Topics covered: Pharma, biotech, FDA, gene therapy, clinical trials, drug pricing and much more. Investors signaled disappointment as well. The FDA had its hands full while under Gottlieb. 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. For more on investing in health care innovation, click here to join us at our Healthy Returns Summit in New York City on May 21. In the meantime, here are five key takeaways from Gottlieb's departure and time at the FDA. "To the extent that he has recognized this trend early and convened workshops and panels for industry, Dr. Gottlieb has done a good job of showing FDA is forward-thinking," said Brad Loncar, a biotech investor and founder of two exchange-traded funds. He also called as many of his FDA colleagues as he could before announcing his resignation. 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. Abernethy came from Roche's Flatiron unit. According to Hills, the agency will surely continue to restructure how it regulates these areas to make the process more effective and transparent. 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. Allyson would tease him about how he wouldn't want to leave D.C. at the end of the week but didn't want to leave his home in Westport, Connecticut, on Sundays either. Should Abernethy get the top spot at the FDA, she "will need to build a similar support network — either with the same group or new faces — that can help in the new political climate with Democratic oversight," he added. The Nasdaq biotech index was down more than 2% Tuesday morning. (He let his daughters pick the vacation. Newly published data show that, after joining a clinical trial, patients who were given a drug from Amylyx Pharmaceutcials lived a median 6.5 months longer than those who didn't. "This is a man who worked hard to ensure the FDA was doing everything in his power, within the scope of its jurisdiction, it could do to lower drug prices," he added. While generally considered positive, Gottlieb's impact on the FDA does raise some issues. That's hard to do.". At the top of the list: spending the summer at home with his family. More clarity should come in the lead up to the leadership change. You'll never have another job like this again,'" Gottlieb recalls him saying. I know enough to know that.". © 2020 CNBC LLC. Hills noted that FDA commissioners tend to have a clinical background and a well-known presence in their research field. 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. "One thing that is really distinguishing factor of Scott was he seemed to have unbounded energy. Questions also persist over whether the FDA's speed in clearing novel drugs has weakened its historical standards on safety and efficacy. https://t.co/GIbry4H2OI. 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. It's still up in the air. A replacement will need to navigate a split Congress where Democrats now control the House of Representatives. 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. Although it is a common refrain amid many departing government officials, according to Gottlieb, it's a family matter. The unexpected exit has created a number of uncertainties for the pharmaceutical industry. Not true, Gottlieb said in an interview at the agency's Silver Spring, Maryland, headquarters, where his office bookcase is filled with family photos. Gottlieb, 46, is husband to Allyson Nemeroff and father to three daughters. A national opioid epidemic pushed the agency to call for new and safer pain medications. "I would expect we may not have another superhuman quite like him.". Right now, there's only one future plan Gottlieb said he's sure of: going to Disney World for spring break. Although he originally planned to stay at the agency through August, the accident helped put his priorities in order, he said. 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. These efforts were happening as the FDA dished out guidance on other areas of drug development, including cell and gene therapy, combination products and continuous manufacturing. He denied knowing what he's going to do next. Gottlieb plans to leave next month. ), "That last week is going to be hard. Novartis CEO Vas Narasimhan and Alnylam Pharmaceuticals head John Maraganore were among the biopharma executives to personally express gratitude. He'll step down before the policy is finalized or implemented. I mean, we get a press release every day out of the FDA, which is crazy," Hills of Mintz Levin said. 3,309 Followers, 81 Following, 43 Posts - See Instagram photos and videos from Scott Gottlieb, MD (@scottgottliebmd) Their phones immediately started ringing. "It will be important for the next FDA commissioner to also show that the agency will be a partner in the development of these new technologies as well.". He says he would have liked for the tobacco policies to be further along, though he says he's "confident" they will get out. Gottlieb will likely be remembered for his balancing act, keeping the FDA's core mission at the forefront even as he worked closely with industry to streamline clinical and approval pathways. He's worked at the FDA multiple times, invested in health-care companies as a venture capitalist and written about health policy at the conservative think tank, the American Enterprise Institute. STEM Careers Coalition Marks First Anniversary By Expanding Membership and Offering New, No-... BenchSci Expands Scientists’ Access to Critical Experimental Insights with Addition of Top J... 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